tag:blogger.com,1999:blog-76499957662793607782024-02-21T04:20:46.233+05:30IP Pharma DocThis blog reviews generic phramaceutical newsUnknownnoreply@blogger.comBlogger731125tag:blogger.com,1999:blog-7649995766279360778.post-68803973048425858372011-12-07T10:34:00.002+05:302011-12-07T11:01:31.946+05:30Atorvastatin+Amlodipine (Caudet): Ranbaxy launched authorized genericThe 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+Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-82311697104677665082011-11-30T19:03:00.007+05:302011-12-01T23:11:57.993+05:30Atorvastatin: Authorized generic arrived, Ranbaxy generic approved with help from TevaThe 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-32397788028104603512011-08-19T23:01:00.004+05:302011-12-01T23:04:22.467+05:30Atorvastatin (Lipitor): The action begins in various marketsThe 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, Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-26559608851834036842011-06-01T15:16:00.003+05:302011-06-01T15:32:27.897+05:30Donepezil (Aricept): 16 generic players got final approval after FTF expiryAbout 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) Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-36447079500601935382010-07-23T17:40:00.004+05:302010-12-27T15:33:35.935+05:30Pantoprazole Sodium (Protonix) patent issues Part II: Court Found Innovator's Key Patent Valid & Infringed by generic playersRefer 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-80874623925600318812010-07-23T17:33:00.001+05:302010-12-27T15:34:41.882+05:30Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg Tablets: Announces Settlement Agreement with innovatorGeneric 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-60786081864910159722010-07-23T15:40:00.003+05:302010-12-27T15:35:48.763+05:30to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets: Mylan announced settlement with innovatorAfter 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-45033078553327721542010-05-31T13:25:00.003+05:302010-06-03T16:53:34.950+05:30Valacyclovir Hydrochloride (Valtrex) 500 mg and 1 g tablets: 8 generic players got final approval from USFDAFollowing 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/Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-39806649159811920512010-05-20T16:10:00.012+05:302010-06-03T18:02:05.187+05:30Generic version of Atorvastatin Calcium tablets approved and launched in CanadaVarious 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-3510846792086333452010-05-05T15:19:00.005+05:302010-05-06T13:01:40.765+05:30Losartan Potassium (Cozaar) and Losartan +HCTZ (Hyzaar/Cozaar Plus): Interesting decisions in US and EUThe 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-37274723579218425752010-04-27T18:28:00.007+05:302010-04-28T12:46:41.155+05:30Pantoprazole Sodium (Protonix) patent issues: Jury decision favorable to innovator; final decision pendingThe 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, 2011Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-46337486355450736612010-04-16T17:56:00.002+05:302010-04-19T09:29:12.983+05:30Sumatriptan and Naproxen (Treximet) 85 mg+500 mg Tablets: Innovator Pozen and generic player Teva settled patent litigationInnovator 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-35884499356611387332010-04-16T17:36:00.002+05:302010-04-23T14:59:17.368+05:30Repaglinide (Prandin) tablets: CAFC refused to change patent use codeIn 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 ‘Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-25190631571073682052010-04-16T16:03:00.003+05:302010-04-17T14:42:39.230+05:30Omeprazole + Sodium Bicarbinate (Zegerid) Capsules and oral suspension: Innovator Santarus’ key patents declared invalid by US courtIn 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 declaredUnknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-26718769597238528202010-04-09T18:09:00.002+05:302010-04-10T13:32:33.343+05:30Losartan (Cozaar) and Losartan + HCTZ (Hyzaar): Teva launched generic versionThe 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 productsUnknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-5006942730577070792010-04-09T13:09:00.000+05:302010-04-09T13:10:00.493+05:30Seasonique: Teva Receives Favorable Court DecisionInnovator 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-70189949627116375892010-04-09T13:07:00.000+05:302010-04-09T13:09:00.532+05:30Oxaliplatin (Eloxatin): Teva Settled patent Litigation with innovator Sanofi & DebipharmJerusalem, 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-19034794045688270332010-04-09T13:06:00.000+05:302010-04-09T13:07:44.550+05:30Gemcitabine (Gemzar®): Teva Provides Update on patent LitigationJerusalem, 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 forUnknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-39413418936294098982010-04-09T13:00:00.000+05:302010-04-09T13:06:02.919+05:30Teva Provides Update on Generic Temodar®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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-76712354963657747012010-04-09T12:59:00.000+05:302010-04-09T13:00:23.221+05:30Teva To Acquire RatiopharmJerusalem, 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-86793740425438601502010-03-03T14:08:00.002+05:302010-03-03T14:12:05.274+05:30Losartan (Cozaar) and Losartan + HCTZ (Hyzaar): Teva won 180 days exclusivityGeneric 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) Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-27946446446466491032010-01-12T16:45:00.005+05:302010-03-04T14:28:50.897+05:30Esomeprazole Magnesium (Nexium) 20 and 40 mg tablets: Innovator Astra settled patent litigation with TevaInnovator 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-15894116332398703252010-01-04T14:29:00.001+05:302010-01-04T14:31:26.693+05:30Paragraph IV Patent Certifications Reported by USFDA as of December 22, 20091. 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,Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-51765544578783147982009-12-23T10:53:00.002+05:302009-12-23T11:00:28.358+05:30Memantine hydrochloride (Namenda) 5 mg and 10 mg Tablets: Lupin entered into licensing agreement with innovatorIndian 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 Unknownnoreply@blogger.com0tag:blogger.com,1999:blog-7649995766279360778.post-28470219553947267612009-12-21T12:06:00.002+05:302009-12-21T12:09:12.268+05:30Montelukast sodium (Singulair): USPTO upheld the validity of compound patent during re-examinationRefer 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 Unknownnoreply@blogger.com0