tag:blogger.com,1999:blog-76499957662793607782011-12-07T11:24:32.259+05:30This blog reviews generic phramaceutical newsDr. Amitanoreply@blogger.comBlogger7311100tag:blogger.com,1999:blog-7649995766279360778.post-68803973048425858372011-12-07T10:34:00.002+05:302011-12-07T11:01:31.946+05:30

The generic player Ranbaxy has launched the authorized generic version of Amlodipine+ Atorvastatin (Caudet) tablets in US market. This was confirmed by the generic pharma giant in following press release: http://www.ranbaxy.com/news/newsdisp.aspx?cp=988&flag=LNInnovator Pfizer is currently marketing about 11 combination strenghts in US market (Amlodipine+Atorvastatin):10+10, 10+20, 10+40, 10+80,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-82311697104677665082011-11-30T19:03:00.007+05:302011-12-01T23:11:57.993+05:30

The historic day for American public to welcome generic version of Blockbuster drug Atorvastatin hemicalcium tablets (Lipitor). In India, every person working in the Pharma industry was eagerly awaiting news about generic approval and launch by Ranbaxy. However, it was not clear that Ranbaxy would be able to launch the generic version till Nov 30 evening. However, Dec 1 morning in India bring

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-32397788028104603512011-08-19T23:01:00.004+05:302011-12-01T23:04:22.467+05:30

The richest molecule Atorvastatin is approching patent expiry in regulated market in US and EU and as the D-day is approching there has been new twists in activities by generic or innovator companies. The recent press releases have started disclosing their plans:1. Innovator Pfizer revealed that they intend to make OTC switch.2. Merck filed NDA on Ezetimibe+ Atorvastatin with USFDA. Although,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-26559608851834036842011-06-01T15:16:00.003+05:302011-06-01T15:32:27.897+05:30

About 16 players got final approval on Donepezil Hydrochloride 5 and 10 mg tablets for US market. Earlier, the First para IV filer Ranbaxy got final approval on Nov 26, 2010 after the expiry of compound patent.After the FTF expiry on May 30, 2011, the USFDA approved generic version of this medication on May 31, 20111) Teva2) Cipla3) Mutual4) Roxane5) Aurbindo6) Hikma7) Sandoz8) Pliva9) Sun10)

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-36447079500601935382010-07-23T17:40:00.004+05:302010-12-27T15:33:35.935+05:30

Refer to my earlier blog post on Pantoprazole Jury decision (http://ippharmdoc.blogspot.com/2010/04/pantoprazole-sodium-protonix-patent.html).Now, the pharma giant Teva Pharma announced that the U.S. District Court for the District of New Jersey denied Teva's motion to overturn key patent US4758579 (Expiry: Jan 19, 2011) w.r.t jury verdict finding the patent in suit not invalid.As per press

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-80874623925600318812010-07-23T17:33:00.001+05:302010-12-27T15:34:41.882+05:30

Generic player Mylan announced that its subsidiary Matrix Laboratories Limited received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn(R) ER, a treatment for acne, sold by Medicis Pharmaceuticals

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-60786081864910159722010-07-23T15:40:00.003+05:302010-12-27T15:35:48.763+05:30

After settlement with generic player Lupin and others, the innovator Forest and Merz Pharma have settled the patent litigation w.r.t method of use patent U.S. Patent No. 5,061,703 (scheduled to expire in April, 2015) with generic player Mylan. Mylan has confirmed in a press release that that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-45033078553327721542010-05-31T13:25:00.003+05:302010-06-03T16:53:34.950+05:30

Following 8 generic players have obtained final approval to market generic version of Valacyclovir (Valtrex) 500 mg and 1 g tablets in US market:1. Dr. Reddy's Laboratories2. Mylan Pharmaceuticals Inc: http://investor.mylan.com/releasedetail.cfm?ReleaseID=4734893. Matrix Laboratories Ltd.4. Roxane Laboratories, Inc.5. Sandoz Inc.,6. Teva Pharmaceuticals USA: http://www.tevapharm.com/pr/2010/pr_

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-39806649159811920512010-05-20T16:10:00.012+05:302010-06-03T18:02:05.187+05:30

Various generic players have received the Notice of Compliance from Health Canada to market generic version of Atorvastatin Calcium (Lipitor) 10, 20, 40 and 80 mg tablets in Canadian market.The generic players like a) Apotex, b) Pharmascience, c) Teva, d) Sandoz, e) Watson, F) Cobalt, g) NovoPharm and h) Ratiopharm have received Notice of Compliance letters on this blockbuster formulation on May

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-3510846792086333452010-05-05T15:19:00.005+05:302010-05-06T13:01:40.765+05:30

The generic players for Angiotensin Receptor Blocker (ARB) medicine Losartan Potassium (Cozaar) and Losartan + Hydrochlorthiazide (Hyzaar/Cozaar Plus) in the last 8-9 months have witnessed various interesting decisions in the courts, patent offices and regulatory agencies of US and Europe.In US, generic player Teva secured First To File (FTF) 180 days exclusivity by challenging innovator Merck’s

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-37274723579218425752010-04-27T18:28:00.007+05:302010-04-28T12:46:41.155+05:30

The generic player Teva (announced in a press release here ) about ongoing patent litigation and jury’s decision on Pantoprazole Sodium (Protonix) formulation.The Jury appointed by US district Court for the district of New Jersey has opined on April 23, 2010 that innovator Nycomed’s ( who licensed the molecule’s patents to wyeth, now part of Pfizer) compound patent US4758579 (Expiry: Jan 19, 2011

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-46337486355450736612010-04-16T17:56:00.002+05:302010-04-19T09:29:12.983+05:30

Innovator Pozen (announced in a press release here) and generic player Teva settled patent litigation w.r.t generic version of the migraine treatment Sumatriptan and Naproxen (Treximet) 85 mg+500 mg Tablets. Innovator Pozen has strong patent portfolio on this formulation. The listed patent has claims on method of use, formulation and pharmacokinetic properties of the combination Both parties

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-35884499356611387332010-04-16T17:36:00.002+05:302010-04-23T14:59:17.368+05:30

In a dispute between innovator Novo Nordisc and generic player Caraco on patent Use code listed for following Orange book listed patent on antidiabetic formulation Repaglinide tablets:US6,677,358 (Expiry: Jun 12, 2018): which covers use of Repaglinide in combination with MetforminThe CAFC has refused to correct patent use code boundary.The dispute is due to following patent use cod listed for ‘

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-25190631571073682052010-04-16T16:03:00.003+05:302010-04-17T14:42:39.230+05:30

In a significant decision, the U.S. District Court for the District of Delaware has declared the Orange Book listed patents of innovator Santarus (who has got licensed on the patents from University of Missouri) for Omeprazole + Sodium Bicarbinate (Zegerid) 20 mg; 1.1 g and 40 mg ;1.1 g Capsules and 20 mg/PACKET;1.68 g/PACKET and 40 mg/PACKET;1.68 g/PACKET powder for oral suspension were declared

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-26718769597238528202010-04-09T18:09:00.002+05:302010-04-10T13:32:33.343+05:30

The generic player M/S Teva Pharma announced (in a press release Here ) that the U.S. Food and Drug Administration (USFDA) has granted final approval for the Company's generic versions of innovator Merck's antihypertensive Losartan (Cozaar) 25 mg, 50 mg and 100 mg tablets and Losartan + HCTZ (Hyzaar) 100+ 12.5, 50+12.5, 100 + 25 mg tablets. Importantly, company is first to file on these products

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-5006942730577070792010-04-09T13:09:00.000+05:302010-04-09T13:10:00.493+05:30

Innovator Teva Pharma announced (in a press release Here ) that the U.S. District Court for the District of Nevada has granted Teva's Motion for Summary Judgment with respect to the validity of U.S. Patent No. 7,320,969. In March 2008, Duramed, now Teva Women's Health, brought suit in the District of Nevada against Watson alleging infringement of Teva's patent as a result of Watson's filing of

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-70189949627116375892010-04-09T13:07:00.000+05:302010-04-09T13:09:00.532+05:30

Jerusalem, April 1, 2010 - Teva Pharma announced (announced in a press release Here )today that patent infringement litigation pertaining to Teva's generic version of sanofi-aventis and Debiopharm's Oxaliplatin (Eloxatin) has been dismissed by the United States District Court for the District of New Jersey pursuant to a settlement between the parties. The settlement, which provides for a full

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-19034794045688270332010-04-09T13:06:00.000+05:302010-04-09T13:07:44.550+05:30

Jerusalem, April 1, 2010 Teva Pharma announced (announced in a press release Here ) today that the U.S. District Court for the Southern District of Indiana issued a decision yesterday on two patents for Gemcitabine (Gemzar®); the compound patent expiring on November 15, 2010, and a method of use patent expiring on May 7, 2013. As to the method of use patent, the Court denied Lilly's request for

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-39413418936294098982010-04-09T13:00:00.000+05:302010-04-09T13:06:02.919+05:30

Jerusalem, March 17, 2010 - Teva Pharma announced (in a press release Here) today that the parties to the patent litigation regarding Barr's U.S. generic version of Schering's Temodar® have entered into an agreement pending resolution of Schering's appeal to the Federal Circuit of the U.S. District Court's decision holding the '291 Patent unenforceable. Under the terms of the agreement, subject

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-76712354963657747012010-04-09T12:59:00.000+05:302010-04-09T13:00:23.221+05:30

Jerusalem, Israel, March 18, 2010 - Teva Pharmaceutical Industries Ltd. announced (in a press release Here) that it has entered into a definitive agreement to acquire ratiopharm, Germany's second largest generics producer and the sixth largest generic drug company worldwide, for an enterprise value of 3.625 billion euro. The transaction is subject to certain conditions including relevant

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-86793740425438601502010-03-03T14:08:00.002+05:302010-03-03T14:12:05.274+05:30

Generic player Teva has won 180 days exclusivity for Losartan (Cozaar) and Losartan + HCTZ (Hyzaar) after Court of Appeals for District of Columbia Circuit overturned a lower court's decision that Teva had forfeited its exclusivity rights in the light of delisting of another Orange Book patent on polymorph by innovator Merck & patent assignee Du Pont. The product patent on Losartan (Cozaar) and

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-27946446446466491032010-01-12T16:45:00.005+05:302010-03-04T14:28:50.897+05:30

Innovator Astra settled patent litigation with Teva pending in the U.S. District Court for the District of New JerseyAfter first settling with first paara IV filer Ranabxy in April, 2008, innovator M/S AstraZeneca has entered into a licensing agreement with generic player Teva and as per terms of the settlement Teva would be able to launch the generic version in May 27, 2014 (after the expiry of

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-15894116332398703252010-01-04T14:29:00.001+05:302010-01-04T14:31:26.693+05:30

1. Amlodipine Besylate and Atorvastatin Calcium (Caudet) 2.5 mg + 40 mg Tablets: Para IV filed on Sep 17, 20092. Arformoterol Tartrate (Brovana) Eq. 0.015 mg base/2 mL Inhalation Solution: Para IV filed on Oct 1, 20093. Niacin and Simvastatin (Simcor)1000 mg + 20 mg Extended-release Tablets: Para IV filed on Sep 17, 20094. Vardenafil Hydrochloride (Levitra) 2.5 mg Tablets: Para IV filed on Sep 4,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-51765544578783147982009-12-23T10:53:00.002+05:302009-12-23T11:00:28.358+05:30

Indian Pharma Giant M/S Lupin Pharma has announced that it has settled the litigation with innovator Forest Lab and Merz Pharma, which was pending in Delaware District Court, Maryland District Court and District of Columbia w.r.t generic version of Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets.Innovator has listed following patent in Orange Book for Memantine hydrochloride 5 mg and 10

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-28470219553947267612009-12-21T12:06:00.002+05:302009-12-21T12:09:12.268+05:30

Refer to our earlier post on Montelukast reexamination Here, Now, an article published in reuters (here ) reported that USPTO has upheld the validity of the key patent during re-examination. Now, generic version would be blocked till compound patent expiry in Aug 3, 2012.BackgroundEarlier, the United States Patent & Trademark Office (USPTO) had accepted the request of a Independent firm Article

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-2115548185143980992009-12-21T12:01:00.002+05:302009-12-21T12:05:28.961+05:30

The Court of Appeal for Federal Circuit(CAFC) has affirmed (Here) a summary judgment decision by U.S District Court for the District of New York on Omeprazole Delayed Release 20 mg and 40 mg Capsules (Prilosec OTC), wherein, court has opined that generic player Dr. Reddy’s generic version of Prilosec OTC would not infringe innovator Astra Zeneca’s following Orange Book listed patents:US5900424 (

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-71992151637791357462009-12-14T10:29:00.000+05:302009-12-14T10:31:31.196+05:30

1. Adapalene 0.30% Topical Gel (Differin): Paragraph IV filed on Sep 15, 20092. Colesevelam Hydrochloride 625 mg (Welchol ) Tablets: Paragraph IV filed on July 1, 20093. Fulvestrant 50 mg/mL, 2.5 mL and 5 mL syringe (Faslodex): Paragraph IV filed on Oct 1, 20094. Levofloxacin 25 mg/mL Oral Solution (Levaquin): Paragraph IV filed on July 30, 20095. Linezolid 2 mg/mL, 300 mL bag Injection (Zyvox):

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-35155809769120510492009-12-12T15:10:00.000+05:302009-12-12T15:17:42.380+05:30

Innovator Pfizer has sued generic player Dr. Reddy’s on Dec 8, 2009 for filing ANDA with Para IV certification against Orange Book listed patents for Atorvastatin (Lipitor) tablets in the U.S. District Court for the District of DelawareInnovator has asserted following polymorph patent against generic player:US5969156 (Expiry: June 8th, 2017): Which covers various hydrated Polymorphs of

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-73845871172175748962009-12-09T12:08:00.004+05:302009-12-09T17:37:14.418+05:30

Generic player Mylan announced (in a press release Here) that its subsidiary Mylan Pharmaceuticals Inc. has entered into settlement and license agreements with Wyeth, now part of Pfizer, relating to Venlafaxine HCl (Effexor XR) 37.5, 75 and 150 mg Capsules.Following patents are listed in Orange Book w.r.t Venlafaxine HCl (Effexor XR) 37.5, 75 and 150 mg Capsules: US6274171 (Expiry: September 20,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-18732558102125728262009-12-09T11:44:00.004+05:302009-12-10T14:13:51.563+05:30

Watson Pharmaceuticals confirmed (in a press release Here ) that its subsidiary, Watson Laboratories filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Ramelteon (Rozerem) 8 mg Tablets.Innovator has listed following patent in the Orange Book for this product:US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-39916624113155010882009-12-09T11:42:00.002+05:302009-12-10T14:11:19.396+05:30

Innovator Pfizer has sued generic player Kremer-Urbans LLC and its partner KUDCO for filing ANDA with Para IV certification against Orange Book listed patent for Atorvastatin (Lipitor) tablets in the U.S. District Court for the District of DelawareInnovator has asserted following polymorph patent against generic player:US5969156 (Expiry: June 8th, 2017): Which covers various hydrated Polymorphs

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-27664599445257225312009-11-27T16:45:00.003+05:302009-11-27T17:38:17.582+05:30

Generic pharma giant Ranbaxy has launched generic version of Valacyclovir hydrochloride (Valtrex) 500 mg and 1 g tablets in USA on November 25, 2009. Earlier, Ranbaxy was the first company who challenged innovator Glaxosmithkline (GSK) following Orange Book listed patent:US4957924 (Expiry: Dec 23, 2009): Which covers Valacyclovir as product.Subsequently, innovator sued Ranbaxy in New Jersey

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-91232685131502520552009-11-20T18:12:00.004+05:302009-11-21T14:48:05.881+05:30

Generic player Glenmark announced (in a press release Here ) the Paragraph IV patent litigation settlement with innovator Medicis Pharmaceutical on Fluocinonide (Vanos) cream and Ciclopirox Olamine (Loprox) gel topical formulations.Fluocinonide (Vanos) 0.10% creamEarlier, innovator Medicis sued Glenmark in New Jersey District Court in June, 2009 for the infringement of following Orange Book

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-33010083200214636562009-11-20T18:02:00.003+05:302009-12-09T17:40:57.999+05:30

Innovator Takeda has appealed against the U.S. District Court for the District of Delaware decision, wherein, court found no infringement by Teva in a patent dispute on Lansoprazole (Prevacid) ODT tablets.Earlier, generic player Teva Pharma announced (in a press release Here ) that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-18216844183175156632009-11-13T14:45:00.004+05:302009-11-13T15:37:13.226+05:30

1) Diclofenac Sodium and Misoprostol (Arthrotec) 50 mg + 0.2 mg DR Tablets : Paragraph IV filed on June 29, 20092) Fluvoxamine Maleate 100 mg Capsules (Luvox CR) 5 mg ad 10 mg Tablets: Para IV filed on April 20, 20093) Glycopyrrolate (Robinul Forte) 1.5 mg Tablets : Para IV filed on May 6, 20094) Vardenafil (Levitra) 5 mg ad 10 mg Tablets: Para IV filed on July 10, 20095) Amoxicillin and

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-37885407555740771442009-11-12T17:47:00.002+05:302009-11-13T16:35:52.964+05:30

In an attempt to block generic version of Ramelteon (Rozerem) 8 mg Tablets, innovator Takeda has filed an infringement action against generic player Teva pharma in U.S. District Court for the District of Delaware. Innovator has listed following patent in the Orange Book for this product:US6034239 (Expiry: Mar 6, 2017): The patent covers Ramelteon as productThe generic player Teva has challenged

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-70092786878380303092009-11-12T17:32:00.005+05:302009-11-13T15:39:07.514+05:30

Brimonidine tartrate ophthalmic solution 0.1% and 0.15% (ALPHAGAN): Innovator announced favorable decision by US courtInnovator Allergan announced (in a press release Here ) that the United States District Court for the District of Delaware has ruled in favor of Allergan on key patents covering Brimonidine tartrate ophthalmic solution 0.1% and 0.15% (ALPHAGAN). The court has upheld the validity

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-45248618631387519942009-10-22T13:03:00.007+05:302009-10-22T16:39:01.784+05:30

Innovator company Cephalon announced (in a press release Here ) that they have received Paragraph IV certification letter from generic player Teva Pharma on October 20, 2009, wherein, Teva has informed innovator that they have filed ANDA with Paragraph IV certification against some selected Orange Book listed patents for Armodafinil 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Tablets (Nuvigil).

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-31660136903106191792009-10-22T13:01:00.001+05:302009-11-13T16:30:15.593+05:30

Innovator Daiichi has got 6 months pediatric exclusivity for Olmesartan and it's combination products in US market.The Orange Book patents would expire on following revised dates:US5616599 (Expiry:Oct 25, 2016): Which covers Olmesartan as productUS6878703 (Expiry:May 19, 2022): which covers combination of Olmesartan with HCTZIn the light of above extension, the generic version would be delayed by

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-84388110283195132952009-10-20T14:38:00.004+05:302009-10-20T14:46:48.507+05:30

Refer to our earlier post Here, wherein, we reported the ANDA filing by generic player Mylan (with Para IV certification) against Glatiramer acetate 20 mg/ml injection (Copaxone). As expected, innovator Teva has reported Here that it has filed a lawsuit against Mylan Pharma and it's API supplier Natco Pharma for patent infringement in the U.S. District Court for the Southern District of New

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-29262048162863992202009-10-20T14:35:00.003+05:302009-10-22T14:45:11.598+05:30

Clindamycin phosphate (1%) and Benzoyl peroxide (5%) gel (Duac®Gel): perrigo announced settlement with innovatorGeneric player Perrigo has settled pending litigation with innovator Stiefel Laboratories (a division of Glaxo SmithKline) on Clindamycin phosphate (1%) and Benzoyl peroxide (5%) gel (Duac®Gel). Eralier, perrigo purchased the ANDA (as reported by Perrigo Here ) for this product from

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-32101245851385865012009-10-15T14:52:00.006+05:302009-10-15T15:21:59.814+05:30

Innovator Pfizer announced (in a press release Here) that it has entered into an agreement with generic player Mylan relating to a generic version of antifungal formulation Vfend (Voriconazole: (2R,3S)-2-(2,4-difluorophenyl)-3- (5-fluoropyrimidin-4-yl)-1- (1H-1,2,4-triazol-1-yl) butan-2- ol) 50 mg and 200 mg tablets. The agreement is limited to the tablet form of Voriconazole and does not cover

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-45477995351815997112009-10-14T16:18:00.001+05:302009-10-14T16:51:49.782+05:30

Innovator Shire, announced (in a press release Here ) that it has settled the pending patent litigation with generic player Sandoz on generic versions of Shire’s ADDERALL XR (mixed amphetamine salts like AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE) for the treatment of Attention Deficit Hyperactivity Disorder.The following patents are listed

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-87686530074532817432009-10-10T13:51:00.004+05:302009-10-10T14:01:28.000+05:30

1) Mycophenolic Acid (Myfortic) 180 mg Delayed-release Tablets: Para IV filed on June 4, 20092) Nisoldipine (Sular ) 8.5 mg and 17 mg Extended-release Tablets: Para IV filed on March 2, 20093) Telmisartan and Hydrochlorothiazide (Micardis HCT) 80 mg+25 mg Tablets: Para IV filed on Feb 27, 20094) Tramadol Hydrochloride (Ryzolt )100 mg, 200 mg and 300 mg ER Tablets: Para IV filed on June 18, 2009 5

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-41474396657544628392009-10-09T15:23:00.001+05:302009-10-09T15:41:12.189+05:30

The United States Patent and Trademark Office (USPTO) announced (in a press release Here ) that it has filed a joint motion with pharma giant GlaxoSmithKline (GSK) to dismiss the lawsuit related to continuation rules.Background of the caseEarlier in August 2007, The USPTO published new rules to improve patent prosecution and examination. However, contentious rules on Final Rule 114 (requests for

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-34559010723052288802009-10-08T17:21:00.003+05:302009-10-08T17:31:14.988+05:30

Innovator Pfizer has initiated patent infringement proceedings against generic player Sandoz for filing ANDA with Para IV certification against Orange Book listed patents on Atorvastatin + Amlodipine Besylate (Caudet) Tablets (80+5 mg and 80+10 mg tablets) in the U.S. District Court for the District of Delaware. Earlier, the generic player Sandoz send Para IV notice letter to innovator on August

Dr. Amitanoreply@blogger.com1tag:blogger.com,1999:blog-7649995766279360778.post-33283050687554314322009-09-30T14:52:00.000+05:302009-09-30T14:53:27.851+05:30

The Court of Appeal for Federal Circuit (CAFC) bench of Circuit Judges Mayer, Gajarsa, and Dyk (with dissent from Gajarsa) in 2-1 decision has upheld the U.S. District Court of Delaware’s decision (as detailed by this blog Here ) that innovator ORTHO MCNEIL JANSSEN’s key patent on Galantamine was invalid because of lack of enablement under 35 USC 112, lack of utility under 35 USC 101.The various

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-33692199622336747272009-09-29T19:59:00.002+05:302009-09-29T20:03:52.849+05:30

Innovator AstraZeneca announced (in a press release Here ) that the US Court of Appeals for the Federal Circuit has affirmed the Summary Judgment decision of No Inequitable Conduct in patent litigation involving Seroquel (quetiapine fumarate) tablets. Earlier in July 2008, the US District Court for the District of New Jersey granted the company's Motion for Summary Judgment of No Inequitable

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-29876638264633498352009-09-29T19:54:00.001+05:302009-09-30T14:13:46.004+05:30

Indian generic player Orchid Pharmaceuticals announced in a press release Here that company has received final approval from US regulatory authority USFDA to market Piperacillin and Tazobactam for Injection’s generic equivalents in 2.25 g, 3.375 g and 4.5 g vial as well as 40.5 g (Pharmacy Bulk Package) dosage forms and strengths. Importantly, Orchid has further confirmed that they have received

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-7409926195578380582009-09-25T16:01:00.002+05:302009-09-25T16:05:18.711+05:30

Japanese pharma giant M/S Astellas Pharma announced (in a press release Here ) that they have initiated the patent infringement action against generic pharma gaint M/S Teva pharma in United States District Court, Southern District of New York on September 22, 2009.Following patent is listed in the Orange Book for Solifenacin Succinate (Vesicare) 5 and 10 mg tablets:US6017927 (Assignee: Yamanouchi

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-27823933717727984102009-09-25T15:56:00.004+05:302009-09-30T15:08:42.310+05:30

Innovator Eli Lilly announced (in a press release Here ) that in a patent dispute with generic player Teva Pharma, the U.S. District Court for the Southern District of Indiana has upheld Eli Lilly and Company's method-of-use patents on Raloxifene Hydrochloride (Evista) 60 mg Tablets. The method of use patents provide patent protection for Raloxifene Hydrochloride (Evista) 60 mg tablets till March

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-2228741249824171292009-09-25T15:50:00.002+05:302009-09-25T15:54:03.573+05:30

Generic player Impax Lab confirmed (in a press release Here ) that it has initiated a Paragraph IV patent challenge to patents listed in the Orange book by innovator M/S Galderma Labs for Doxycycline 40 mg DR capsules (Oracea). Following patents are listed in Orange Book for Doxycycline 40 mg DR capsules (Oracea): US5789395 (Expiry: Aug 30, 2016): Which covers a method for inhibiting nitric oxide

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-64770676510748215262009-09-16T19:28:00.000+05:302009-09-16T19:29:40.021+05:30

The generic player M/S Mylan announced ( in a press release Here) that the U.S. Food and Drug Administration (FDA) has accepted for filing of Mylan Pharma's abbreviated new drug application (ANDA) for Glatiramer Acetate Injection (20 mg/ml), which is a generic version of innovator M/S Teva Pharma’s Glatiramer acetate injection (Copaxone). Glatiramer acetate injection (Copaxone) is indicated for

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-58531414643346830812009-09-15T17:04:00.003+05:302009-09-16T20:04:36.205+05:30

The chief judge honorable G.M. Sleet of U.S. District Court for the District of Delaware has signed off on a request to dismiss M/S Upsher-Smith Lab (and 3 other generic players) from a patent infringement lawsuit that innovator Forest Labs and Merz Pharma brought to thwart the generic challenge to the Alzheimer's drug Memantine (Namenda) hydrochloride 5 mg and 10 mg tablets.Innovator has listed

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-79296355854494289022009-09-15T16:46:00.002+05:302009-09-21T10:08:44.305+05:30

The US district court for the district of New Jersey declined M/S Gate pharma’s declaratory judgment request of non-infringement against 4 patents listed by innovator for Donepezil (Aricept) 5 mg and 10 mg TabletsFollowing patents are listed In the Orange book for 5 and 10 mg tablets of Donepezil hydropchloride:US4895841 (Expiry: NOV 25, 2010)- Product patentUS5985864 (Expiry: DEC 30,2016)-

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-21242550901878606092009-09-15T16:25:00.001+05:302009-09-15T16:36:54.547+05:30

The three generic players namely, Dr. Reddy, Par pharma and Teva Pharma has got final approval from USFDA on September 9, 2009 to market Nateglinide (Starilax) 60 mg and 120 mg tablets.The generic launch was possible after the expiry of product patent USRE34878, which expired on Sep 8, 2009Earlier, Innovator Novartis got final approval to market Nateglinide (Starilax) 60 mg and 120 mg tablets on

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-19476393781984467082009-09-15T16:23:00.000+05:302009-09-15T16:25:00.150+05:30

Innovator M/S Warner Chilcott announced (in a press release Here ) that one of its subsidiaries has filed lawsuits against Indian generic player M/S Lupin Pharma in the District Court for the District of Delaware for infringement of Warner Chilcott's U.S. Patent Nos. 5,552,394 (Expiry: in July 2014) and 6,667,050 (Expiry April 2019), which cover oral contraceptives Loestrin 24 Fe (

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-32787247024937024502009-09-11T11:39:00.005+05:302009-09-11T14:40:48.221+05:30

In a significant decision, The Court of Appeal for Federal circuit (CAFC) has rejected the claim construction of U.S. District Court for the District of New Jersey (decision by Judge J.A. Pisano) on key patent covering anti-cancer parenteral formulation of Oxaliplatin (Eloxatin). Earlier, the district court has granted summary judgment of non-infringement in favor of various generic players like

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-53374407641581497442009-09-07T17:23:00.002+05:302009-09-07T17:27:44.365+05:30

Innovator Orion and Hospira has sued generic player Sandoz in the U.S. to enforce their U.S. Patents covering the proprietary drug Dexmedetomidine hydrochloride (Precedex) 100 mcg base/ml (as reported by orion in press release Here )Orion Corporation and Hospira, Inc. filed together a patent infringement lawsuit in the United States to enforce following Orange Book listed patents:US4910214 (

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-45459655943828100442009-09-07T16:06:00.002+05:302009-09-07T16:13:44.623+05:30

The innovator, M/S Medicines Company announced (in a press release Here) that it has received Paragraph IV Certification notice letters from generic players M/S Teva Parenteral and M/S Pliva wherein, generic players informed the Company that they have submitted Abbreviated New Drug Applications (ANDAs) to the U.S. Food and Drug Administration (USFDA) for approval to market generic versions of

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-53892752108063386152009-09-04T16:24:00.001+05:302009-09-04T16:26:02.976+05:30

Innovator Purdue and Napp Pharma has filed an appeal with the U.S. Court of Appeals for the Federal Circuit (CAFC), challenging the United States District Court for the District of Delaware opinion of invalidation of two key patents US6254887 and US7074430, which covers Tramadol hydrochloride 100mg and 200mg ER tablets (Ultram ER).Earlier on August 16, 2009, United States District Court for the

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-28429791320002992142009-09-02T17:11:00.008+05:302009-09-04T11:08:59.613+05:30

In a patent dispute between generic player Apotex and innovator Upsher-Smith Lab, the U.S. District Court for the Southern District of New York has issued permanent injunction against generic player. (as reported by innovator in press release Here )The court has opined that the disputed patent US6440329, which was reissued after corrections by USPTO as USRE40812 is valid.Earlier in July, 2006,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-61863882234838747222009-08-28T18:04:00.004+05:302009-09-02T15:42:17.872+05:30

The Court of appeal for Federal circuit (CAFC) has reversed a portion of a previously decided summary judgment on patent litigation between innovator Ortho-McNeil ( a subsidiary of Johnson & Johnson) and Caraco (subsidiary of Sun Pharma), Teva regarding Acetaminophen 325 mg + Tramadol Hydrochloride 35.5 mg tablets (Ultracet). Further, the court has remanded the litigation to a lower court for

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-79472047417234426152009-08-27T17:45:00.002+05:302009-08-28T18:18:47.159+05:30

1. Amlodipine Besylate and Atorvastatin Calcium 5 mg + 80 mg tablets (Caduet) Paragraph IV filed on April 4, 20092. Fluvoxamine Maleate Extended- release Capsules (Luvox CR) Paragraph IV filed for 100 mg strength on May 18, 2009 and for 150 mg strength on April 13, 20093. Minoxidil 5% Topical Aerosol Foam (Men’s Rogaine) Paragraph IV filed on April 6, 20094. Paroxetine Hydrochloride 37.5 mg

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-44265860974996561172009-08-21T14:54:00.003+05:302009-08-21T15:09:49.094+05:30

Generic pharma giant Teva Pharma (announced in a press release Here ) that the U.S. District Court for the District of New Jersey has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Merck's Singulair® (Montelukast Sodium) Tablets, holding that product patent listed in Orange Bokk is valid and enforceable. Teva is

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-20241231755129602102009-08-18T18:10:00.001+05:302009-08-19T17:35:01.543+05:30

Innovator Eli Lilly announced (in a press release Here ) that the U.S. District Court for the Eastern District of Michigan has granted a motion by Sun Pharmaceuticals for partial summary judgment against key patent covering method of use of Gemcitabine HCl for injection (Gemzar) 200mg base/vial and 1 g base/vial.The following patents are listed in Orange Book for this product:US4808614 (Patent

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-79473859021629808712009-08-18T18:05:00.003+05:302009-08-19T17:43:05.397+05:30

Innovator Biovail Corporation announced (in a press release Here ) that the United States District Court for the District of Delaware, Honorable Judge Kent A. Jordan has issued an opinion in favour of generic player Par Pharmaceuticals in the patent-infringement litigation relating to Tramadol hydrochloride 100mg and 200mg ER tablets (Ultram ER). Although Biovail is not a party to the action, the

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-17064549280735355862009-08-17T17:47:00.002+05:302009-08-17T17:51:55.956+05:30

Innovator Astellas announced (in a press release Here ) that U.S. District Court in Washington, D.C has refused preliminary injunction and temporary restraining order against USFDA’s approval of ANDA for Tacrolimus (Prograf) 0.5 mg, 1mg and 5 mg capsules.Earlier, innovator informed about Citizen petition refusal by USFDA (in press release Here ). Subsequently, innovator challenged USFDA’s

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-24184660878376029102009-08-12T18:02:00.002+05:302009-08-18T10:28:09.052+05:30

The following generic players have got final/tentative approval to market antimigraine formulation Sumatriptan Succinate 25, 40 and 100 mg tablets (generic version of Imitrex): Final approvals 1. TEVA (ANDA approved on February 9, 2009)2. RANBAXY (25 and 50 mg tablets on August 10, 2009; 100 mg on February 9, 2009)3. DR REDDYS LABS INC (ANDA approved on August 10, 2009)4. COBALT LABS INC (ANDA

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-27727780101216028832009-08-12T17:34:00.001+05:302009-08-12T17:36:52.851+05:30

Generic player Sandoz has announced the introduction of Tacrolimus 0.5 mg, 1mg and 5 mg capsules, a generic equivalent of Prograf, in the US market. Tacrolimus is an immunosuppressive treatment used to help prevent rejection of a kidney or liver transplant.Sandoz is the first and only company to launch generic Tacrolimus in the US, delivering on its strategy of being first-to-market with key

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-52849971194040503632009-08-12T17:31:00.001+05:302009-08-12T17:34:25.863+05:30

Generic player Orchid and innovator Schering-Plough (now, subsidiary of Merck) have settled the patent litigation relating to Desloratadine tablets, 5 mg and Desloratadine 2.5 mg and 5 mg orally disintegrating tablets (ODT). These are generic versions of Schering's Clarinex and Clarinex Reditabs for allergy medication. The litigation has been pending in the US, District Court of New Jersey since

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-13833898480837126582009-08-11T14:40:00.001+05:302009-08-11T14:43:11.155+05:30

1. Solifenacin Succinate Tablets (Vesicare) Para IV filed on April 8, 20092. Dexmedetomidine Injection (Precedex) 100 mcg/mL Para IV filed on April 8, 20093. Quetiapine Fumarate Extended-release Tablets 150 mg (Seroquel XR) Nov 17, 2008(Source: USFDA)

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-13237868649434217012009-08-10T14:23:00.004+05:302009-08-10T16:04:06.067+05:30

1. Candesartan Cilexetil and Hydrochlorothiazide (Atacand HCT) Tablets 32 mg+25 mg Paragraph IV filed on March 6, 2009 (Earlier, a generic company has filed Paragraph IV against Atacand HCT Tablets 16 mg+12.5mg and 32mg+12.5mg on June 25, 2008) 2. Diazepam (Diastat Acudia) Rectal Gel 5 mg/ml, 4mL pre-filled syringe Paragraph IV filed on Dec 8, 2008 and for 2mL pre-filled syringe on Dec 23, 2008 3

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-37797449276241386902009-08-07T16:55:00.002+05:302009-08-10T14:21:01.892+05:30

Innovator company Daiichi Sankyo announced (in a press release Here) that the U.S. District Court in New Jersey has issued a decision in our U.S. patent litigation against Mylan (and its subsidiary Matrix) upholding the validity of our patent covering the Olmesartan (Benicar), Olmesartan+Hydrochlorthiazide (Benicar HCT) and Olmesartan+ Amlodipine (AZOR) formulations. Mylan was the first company

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-51603461189542973112009-08-06T18:09:00.001+05:302009-08-07T17:34:28.796+05:30

Generic pharma giant Teva Pharma announced (in a press release Here ) that U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the U.S. District Court for the District of New Jersey (as reported by us Here ) has declared innovator Bayer's orange book listed patent for Drospirenone and Ethinyl estradiol (Yasmin) 3.0 mg+0.03 mg tablets.The CAFC has declared following key patent

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-69738539036334269652009-08-06T17:48:00.002+05:302009-08-06T17:52:00.945+05:30

Indian Pharma giant Sun Pharma (announced in a press release Here ) that its subsidiaryCaraco Pharma (announced in a press release Here ) has executed a settlement agreement with innovator MedImmune, stipulating the dismissal of the lawsuits filed in the United States District Court for the District of Maryland regarding the submission of an Abbreviated New Drug Application (ANDA) for a generic

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-55112520636190225932009-08-06T17:39:00.001+05:302009-08-06T17:42:55.579+05:30

Innovator Orion Corporation has confirmed (in a press release Here) that generic player Sandoz has filed ANDA with Paragarph IV certification against Orange Book listed patents for Dexmedetomidine hydrochloride 100 mcg base/ml (Precedex) injection. following Orange Book listed patents for Dexmedetomidine hydrochloride 100 mcg base/ml (Precedex) injection:US5344840 (Expiry: Sep 6, 2011): Which

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-80098858723107544802009-08-06T17:35:00.000+05:302009-08-06T17:39:18.158+05:30

Innovator Warner Chilcott Limited announced (announced in a press release Here) that it has received two Paragraph IV Certification Notices from Indian generic player Lupin. The Paragraph IV Certification Notices advise the Company of the filing of Abbreviated New Drug Applications (ANDAs) by Lupin for generic versions of the Company's oral contraceptives Loestrin 24 Fe (norethindrone acetate and

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-84222996170978226812009-07-31T13:35:00.002+05:302009-08-10T14:14:21.990+05:30

Indian pharma giant Ranbaxy Pharmaceuticals Canada Inc announced that RLL has received approval in Canada to manufacture and market Ran-Ropinirole 0.25 mg, 1.0 mg, 2.0 mg, and 5.0 mg tablets (Ropinirole Hydrochloride) from Health Canada, Therapeutic Products Directorate (TPD). Total generic market size of Ropinirole Hydrochloride tablets in Canada is $4.8 million ($CAD) [IMS-CDH: July 2008].

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-23776581604959346092009-07-28T15:37:00.000+05:302009-07-28T15:38:26.938+05:30

Innovator Taro Pharmaceutical Industries (announced in a press release Here ) that it has filed a patent infringement lawsuit against generic players Synerx Pharma, DPT Labs and Karalex Pharma in the United States District Court for New Jersey for infringement of following Orange Book listed patent:US7560445 (Assignee: Taro Pharma; Expiry: Feb 1, 2027): The patent covers a topical pharmaceutical

Dr. Amitanoreply@blogger.com1tag:blogger.com,1999:blog-7649995766279360778.post-62211622897293064272009-07-28T14:15:00.005+05:302009-07-28T15:10:35.467+05:30

Generic player Teva Pharma announced (in a press release Here ) that Teva has entered into a licensing agreement with innovator Ortho-McNeil-Janssen to settle the patent infringement lawsuit in the U.S. District Court for the District of New Jersey related to Teva's generic version of the oral contraceptive formulation Norgestimate+Ethinyl Estradiol (Ortho Tri-Cyclen) 0.18 + 0.025 mg, 0.215 +

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-74145389006435542012009-07-24T11:41:00.001+05:302009-07-24T11:45:17.801+05:30

Rivastigmine 1.5, 3, 4.5 and 6 mg capsules & 2 mg/ml solution: Generic player Synthon announced (in a press release Here ) that Synthon has successfully completed multiple decentralized procedures (DCP) for Rivastigmine. Regulatory clearance has been obtained for Synthon's product in nearly all European countries. Registration has been obtained for multiple dosage forms including capsules (1.5, 3

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-43674014203952202232009-07-17T09:59:00.001+05:302009-07-17T10:01:56.300+05:30

Generic player Watson Pharma confirmed (in a press release Here) that company has filed an Abbreviated New Drug Application (ANDA) with Paragraph IV certification against innovator Supernus Pharma and Allergen’s Orange Book listed patents on Trospium chloride Extended Release 60 mg Capsules (Sanctura XR). Watson has challenged following Orange Book listed patent:US7410978 (Assignee: Supernus;

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-46955290951617774202009-07-16T12:58:00.004+05:302009-07-16T17:10:46.331+05:30

Innovator Forest Labs and H. Lundbeck have settled pending litigation with generic player Sun pharma and its subsidiary Caraco on Orange Book listed patents USRE34712, US6916,941, and US7420,069 (As per Forest’s press release Here and Sun Pharma's press release Here) on Escitalopram Oxalate (Lexapro) 5, 10, and 20 mg tablets . Before settlement, the companies were litigating on USRE34712 (

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-30463889280841069022009-07-10T17:24:00.002+05:302009-07-10T17:42:58.891+05:30

Generic player Ratiopharm Canada has won a five-year long legal battle against innovator Pfizer’s key patent covering Amlodipine besylate (Norvsac). The said decision will allow the marketing of Amlodipine Besylate (Norvasc) 2.5 mg, 5 mg and 10 mg tablets by generic manufacturers. Generic player Ratiopharm challenged the following patent in 2004 :CA1321393 (Expiry: August, 2010): which covers A

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-51786641990962312472009-07-10T16:28:00.001+05:302009-07-10T16:30:21.282+05:30

Teva Pharma (as per press release Here) has stopped shipping a generic version of innovator Johnson & Johnson's birth control pill Ortho Tri-Cyclen (Norgestimate / Ethinyl Estradiol).Teva agreed to stop shipping the drug till a preliminary injunction hearing in a patent infringement lawsuit from innovator Johnson & Johnson. The Preliminary Injunction hearing is scheduled to begin on July 15.

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-72659204603420976112009-07-10T16:22:00.004+05:302009-07-10T16:28:24.131+05:30

Innovator Takeda Pharma has sued Indian generic player Torrent Pharma in U.S. District Court for the Southern District of New York in a bid to block generic challenge on Pioglitazone Hydrochloride (Actos) 15, 30 and 45 mg tablets. Innovator Takeds in it’s complaint has asserted six patents against Torrent and has requested court to block generic approval till (June, 2016) expiry of asserted

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-80986565561375197552009-07-10T16:13:00.003+05:302009-09-21T10:22:16.796+05:30

Reuters has reported Here that Generic player Apotex in a bid to trigger 180 days exclusivity of generic player Ranbaxy has filed Declaratory Judgment request of non-infringement against innovator Esai’s Orange Book listed patents on Donepezil Hydrochloride (Aricept) 5 and 10 mg tablets in the U.S. District Court for the Middle District of North CarolinaFollowing patents are listed In the Orange

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-56845842940806815112009-07-09T11:28:00.003+05:302009-07-09T18:48:15.975+05:30

Innovator GALDERMA LABS LP has sued Indian generic player Lupin in US District Court for the District of Delaware for filing ANDA with Para IV certification on DOXYCYCLINE DELAYED RELEASE (ORACEA ) Capsules 40 mg.Following patents are listed in Orange Book for this product:US5789395 (Expiry: Aug 30, 2016): Which covers a method for inhibiting nitric oxide production in a mammal system, comprising

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-29195162511898893232009-07-08T10:10:00.001+05:302009-07-08T10:13:18.454+05:30

Various generic players have received final approval to market anti-cancer formulation Bicalutamide (Casodex) 50 mg tablets after the expiry of product patent US4636505 (Expiry: Apr 1, 2009) in USA. Following generic players have got final approval from USFDA:1. Teva2. Synthon3. Kudoco Ireland4. Sandoz5. Accord Healthcare6. Zydus Pharma7. Sun Pharma8. MylanThe generic Bicalutamide (Casodex) 50

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-41309116467712190662009-07-06T16:24:00.003+05:302009-07-08T09:52:07.618+05:30

In a significant and pro-patient judgment, the Intellectual Property Appellate Board (IPAB), has ruled that innovator Novartis's controversial anti-cancer drug, Imatinib Mesylate tablets (Gleevac), lacks patentability and refused patent to innovator. The said patent was challenged by Indian generic players like Natco, Ranbaxy, Cipla and some NGO’s like Cancer Patient Aid Association.The IPAB

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-65447496549936088152009-07-06T12:50:00.002+05:302009-07-08T18:09:37.827+05:30

Hyderabad based generic player Dr. Reddy's Laboratories has received tentative approval on June 26, 2009 from the USFDA on generic Valacyclovir hydrochloride (Valtrex) 500 mg and 1 g tablets. The product patent US4957924 will expire on Dec 23, 2009. Also, innovator has listed two additional patents in Orange Book for this product US5879706 and US6107302 (both patents will expire on Jul 19, 2016),

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-60451773802278852302009-07-06T12:49:00.000+05:302009-07-06T12:50:24.648+05:30

1. Ursodiol tablets 250 mg and 500 mg: Authorized generic leader Prasco Laboratories announced that it has entered into a distribution and supply agreement with Axcan Pharma. for Authorized Generic versions of Ursodiol 250 mg and 500 mg tablets. The details are Here2. Azelastine (Optivar) ophthalmic solution: Indian Pharma giant Sun Pharma announced in a press release Here the tentative approval

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-69272495844679696152009-07-06T12:33:00.002+05:302009-07-06T12:49:05.554+05:30

In a significant decision by THE HONOURABLE MR JUSTICE KITCHIN of Court of Appeal for England and Wales on dispute between generic player Generics (UK) Ltd v Daiichi Pharma (innovator), court opined that SPC (supplementary protection certificate no. SPC/GB97/085) granted to product patent European Patent (UK) No. 0206283, which covers Levofloxacine is justified and not invalid. The ‘283 patent

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-71688703177553562432009-07-03T11:09:00.004+05:302009-07-03T11:22:34.548+05:30

Innovator Bayer has sued generic player Teva in US district court for the district of Delaware in a bid to block generic version of Vardenafil Hydrochloride (Levitra) 2.5 mg, 5 mg, 10 mg and 20 mg tablets.Innovator has sued Teva for the infringement of following Orange Book listed patent:US6362178 (Expiry: Oct 31, 2018): Which covers a method of treating chronic heart failure or erectile

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-91997982195549828032009-06-30T17:18:00.001+05:302009-06-30T17:42:08.141+05:30

Innovator Daiichi has sued generic player Apotex for filing ANDA with Paragraph IV certification to market Cevimeline Hydrochloride (Evoxac) 30 mg Capsules. Innovator has sued Apotex in US district court for the district of Delaware. Following patents are listed in the Orange Book for this product:US4855290 (Expiry: Aug 30, 2009): which covers various quinuclidine derivatives as productUS5340821

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-81563925869119385502009-06-30T17:12:00.003+05:302009-06-30T17:48:25.250+05:30

In one of the important jury verdict, an Eastern District of Texas jury has opined that Abbott should pay around $1.6 billion in damages for infringing Centocor and New York university’s following patent on TNF alpha:US7070775 (Assignee: New York University & Centocor; Date of Grant: July 4, 2006): which covers an isolated recombinant anti-TNF-.alpha. antibody or antigen-binding fragment thereof,

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-61261305342910445072009-06-29T15:24:00.003+05:302009-06-29T15:32:37.527+05:30

Various organisation have reacted diffrently to Federal Trade Commission report on Authorized Generics, during the 180-day Exclusivity Period. The generic player Prasco (an authorized generic leader) and Generic pharmaceutical Association (GPhA) has released press release on this issue. Prasco applauds FTC reportPrasco Laboratories, a Mason-based independent authorized generic company, applauds

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-84957607602541999412009-06-26T11:37:00.004+05:302009-06-26T12:14:00.196+05:30

'Authorized generic' is a contentious issue between generic players and pioneer companies. Various generic players have constantly opposed the launch of authorized generics by innovator, which affect sale of First Para IV filer generic player during 180 days generic exclusivity period. The “authorized generic’ launch is the last resort for innovator companies when the generic launch is imminent.

Dr. Amitanoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-15431447608388540672009-06-25T15:28:00.003+05:302009-06-25T15:42:24.335+05:30

Generic player Synthon have filed ANDA with Paragraph IV certification against innovator Sepracor/UCB’s Orange Book listed patents on Levocetirizie Dihydrochloride (Xyzal) Oral Solution 2.5 mg/5ml. Following patent is listed in Orange Book for this product:US5698558 (Expiry: September 24, 2012): This patent covers a method of treating the symptoms of seasonal and perennial allergic rhinitis in a

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