Thursday 22 October 2009

Armodafinil 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Tablets (Nuvigil): Innovator confirmed receipt of Para IV notice letter from Teva

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).

Following Patents are listed in Orange Book for Armodafinil 50 mg, 100 mg, 150 mg, 200 mg and 250 mg Tablets (Nuvigil):

US4927855 (Assignee: Laboratoire L. Lafon; Expiry: Oct 22, 2010): Which covers (-)-Benzhydrylsulfinylacetamide and derivatives as product

US7132570 (Assignee: Cephalon France; Expiry: Jun 18, 2024): The said patent covers crystalline polymorphic form I of Armodafinil

US7297346 (Assignee: Cephalon Inc; Expiry: May 29, 2024): Which covers a pharmaceutical composition of Armodafinil

USRE37516 (Assignee: Cephalon, Inc; Expiry: Apr 6, 2015): Which covers particle size of Armodafinil

As per press release, Teva has filed ANDA with Paragraph IV certification against ‘570, ‘346 and ‘516 patents. Importantly, Teva has not challenged compound patent '855.

Armodafinil, which is chemically, (–)-2-[(R)-(diphenylmethyl)sulfinyl]acetamide improves wakfulness and used as stimulant agent in the treatment of hypersomnia.

Olmesartan (Benicar), Olmesartan+Hydrochlorthiazide (Benicar HCT) and Olmesartan+ Amlodipine (AZOR) formulations: Innovator got Pediatric exclusivity

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 product

US6878703 (Expiry:May 19, 2022): which covers combination of Olmesartan with HCTZ

In the light of above extension, the generic version would be delayed by 6 months.

The generic for Olmesartan tablets (Benicar) would be expected after Oct 25, 2016.

The generic version for Olmesartan+ Amlodipine (AZOR) formulations would be expected after Oct 25, 2016.

Further, Olmesartan+Hydrochlorthiazide (Benicar HCT) would be expected after May 19, 2022

Tuesday 20 October 2009

Glatiramer acetate 20 mg/ml injection (Copaxone): Teva sued Mylan

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 York.

Innovator Teva has listed US5981589, US6054430, US6342476, US6362161, US6620847, US6939539 and US7199098 patents in Orange Book for Glatiramer acetate 20 mg/ml injection (Copaxone). The said patents would expire on May 24, 2014. As per complaint filed in in the U.S. District Court for the Southern District of New York, Teva has requested court to block the generic version’s approval till May 24, 2014.

Earlier, innovator has sued generic players Momenta and Sandoz in U.S. District Court for the Southern District of New York for filing ANDA in Jul, 2008.

Pharma news

Clindamycin phosphate (1%) and Benzoyl peroxide (5%) gel (Duac®Gel): perrigo announced settlement with innovator

Generic 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 first para IV filer KV pharma.

Lilly to Sell Tippecanoe Manufacturing Site to Evonik Industries
Pharma Giant Eli Lilly and Company announced (in a press release Here ) the sale of its Tippecanoe Laboratories manufacturing facility to Evonik Industries AG, one of the world's largest chemical companies

Update on Oct 22, 2009

Dr. Suresh Pillai of Patent docs has reviewed the following interesting cases:

1) Escitalopram (Lexapro)

2) Memantine (Namenda)

3) Moxifloxacin (Vigamox)

For details, please check following link:

http://www.patentdocs.org/2009/10/biotech-2.html

Thursday 15 October 2009

Voriconazole 50 mg and 200 mg Tablets (Vfend): Pfizer announced settlement and licensing agreement with Mylan

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 Pfizer’s Voriconazole products for intravenous use or oral suspension.

The following patents are listed in Orange Book:

US5116844 (Expiry: Aug 11, 2009): which covers composition
US5364938 (Expiry: Nov 15, 2011): Covers Voriconazole generically
US5567817 (Expiry: May 24, 2016): Covers Voriconazole specifically
US5773443 (Expiry: Jan 25, 2011): Covers Voriconazole generically

Earlier, first Para IV filer, Matrix submitted its ANDA on April 14, 2008, as reported earlier by IP Pharma Doc Here. Importantly, Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval.

Voriconazole 50 mg and 200 mgTablets (Vfend) was approved by USFDA on May 24, 2002.
Pursuant to the agreement, Mylan will have the right to market voriconazole tablets in the United States in the first quarter of 2011. Additional details of the agreement with Mylan remain confidential. The agreement is subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Wednesday 14 October 2009

Amophetamine salts (ADDERALL XR) 5, 10, 15, 20, 25 and 30 mg ER Capsules: Shire and Sandoz Settled patent litigation

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 in Orange Book for this product:

US6322819 (Assignee: Shire Laboratories; Date of Grant: November 27, 2001; Expiry: Apr 21, 2019): which covers a pharmaceutical composition for delivery of one or more pharmaceutically active amphetamine salts, comprising: (a) one or more pharmaceutically active amphetamine salts covered with an immediate release coating; and (b) one or more pharmaceutically active amphetamine salts that are covered with an enteric release coating that provides for delayed pulsed enteric release, wherein said enteric release coating releases essentially all of said one or more pharmaceutically active amphetamine salts coated with said enteric coating within about 60 minutes after initiation of said delayed pulsed enteric release.

US6605300 (Assignee: Shire Laboratories; Date of Grant: August 12, 2003; Expiry: Apr 21, 2019): A pharmaceutical formulation for delivery of a mixture of amphetamine base salts effective to treat ADHD in a human patient comprising: an immediate release dosage form that provides immediate release upon oral administration to said patient; a delayed enteric release dosage form that provides delayed release upon oral administration to said patient; and a pharmaceutically acceptable carrier; wherein said amphetamine base salts comprise dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate; wherein said pharmaceutical formulation is sufficient to maintain an effective level of amphetamine base salts in the patient over the course of at least 8 hours without further administration of amphetamine base salt, and the peak plasma concentration of amphetamine base salts reached after release of said delayed enteric release dosage form exceeds the peak plasma concentration previously reached after release of said immediate release dosage form; and wherein said pharmaceutical formulation, when containing about a total dose of 20 mg, will produce in a human individual a plasma concentration versus time curve (ng/ml versus hours) having an area under the curve (AUC) of about 467 to about 714 ng hr/ml.


The generic player Sandoz challenged Orange Book patents in 2007, subsequently, innovator sued Sandoz in Colorodo District Court.

As part of the settlement, Sandoz has agreed to a consent judgment confirming that its proposed generic products infringe Shire’s ’819 and ’300 Patents and that the two patents are valid and enforceable. Also as per press release, resolution of the case against Sandoz ends all pending litigation against generic ANDA applicants over ADDERALL XR. As per press release, the US Federal Trade Commission (FTC) would review the said agreement.


The settlement also provides Sandoz with a license to market it own generic versions of ADDERALL XR in the United States beginning upon approval of its own generic products by the USFDA and Sandoz will pay Shire a royalty from those sales. Also, no payments to Sandoz are involved in the settlement agreement. Impax Pharmaceuticals Inc. and Barr Laboratories Inc. remains the only authorized generic supplier of ADDERALL XR.


Earlier, innovator Shire got approval to market this combination product on Oct 11, 2001 (30, 20 and 10 mg Capsules) and on May 22, 2002 (15, 5 and 25 mg capsules)

Saturday 10 October 2009

New Paragraph IV certifications reported by USFDA from Sep 8, 2009 to Oct 8, 2009

1) Mycophenolic Acid (Myfortic) 180 mg Delayed-release Tablets: Para IV filed on June 4, 2009

2) Nisoldipine (Sular ) 8.5 mg and 17 mg Extended-release Tablets: Para IV filed on March 2, 2009

3) Telmisartan and Hydrochlorothiazide (Micardis HCT) 80 mg+25 mg Tablets: Para IV filed on Feb 27, 2009

4) Tramadol Hydrochloride (Ryzolt )100 mg, 200 mg and 300 mg ER Tablets: Para IV filed on June 18, 2009

5) Carbidopa, Levodopa and Entacapone (Stalevo 75 and Stalevo 125) Tablets: Para IV filed on May 19, 2009

6) Ephinephrine (Epipen) Injection: Para IV filed on Nov 21, 2008

7) Docetaxel (Taxotere) Injection 40mg/mL, 0.5mL and 2mL vials: Para IV filed on June 30, 2009

8) Piperacillin and Tazobactam (Zosyn) For Injection 2.25 g/vial, 3.375 g/vial, 4.5 g/vial: Para IV filed before Feb 5, 2009

9) Repaglinide and Metformin (Prandimet) 1 mg + 500 mg and 2 mg + 500 mg Tablets : Para IV filed on April 9, 2009

Source: USFDA website Here

Friday 9 October 2009

Continuation patent Applications: USPTO and GSK settled patent litigation

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 case

Earlier in August 2007, The USPTO published new rules to improve patent prosecution and examination. However, contentious rules on Final Rule 114 (requests for continued examination), Final Rule 75 (claims), and Final Rule 265 (examination support documents) were opposed.

After the said notification, an inventor Dr. Triantafyllos Tafas and GSK (and others) opposed said rule and filed complaint in U.S. District Court of the Eastern District of Virginia. Later in April, 2008 the district court sided with GSK, subsequently, USPTO appealed against said decision in U.S. Court of Appeals for the Federal Circuit (CAFC).


On March 20, 2009, the CAFC issued a decision addressing:
a) whether the Claims and Continuation Final Rules fall within the scope of the USPTO’s rulemaking authority and
b) whether the Final Rules are contrary to the Patent Act.


The Court opined that the Final Rules were all within the agency’s rulemaking authority. The Court also concluded that Final Rule 114 (requests for continued examination), Final Rule 75 (claims), and Final Rule 265 (examination support documents) are consistent with the Patent Act, but that Final Rule 78 (continuations) violates the Patent Act. The Court remanded several issues to the district court.

In 2009, the Federal Circuit granted rehearing en banc, and ordered additional briefing that would have commenced in the coming weeks.

Thursday 8 October 2009

Atorvastatin + Amlodipine Tablets (Caudet): Pfizer sued Sandoz for filing ANDA with Para IV certification

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 24, 2009, subsequently, innovator sued generic player on Oct 6, 2009 in U.S. District Court for the District of Delaware

Following patents are listed in Orange Book for Atorvastatin + Amlodipine Besylate (Caudet) Tablets:


US4681893 (Expiry: 24 March, 2010)- Covers racemic form of Atorvastatin generically.

USRE40667/ US5273995 (Expiry: 28th June, 2011)- Covers Atorvastatin enantiomer and salts as Product (Specifically)

US5686104 (Expiry: 11th May, 2015)- Covers stable Formulation

US5969156 (Expiry: 8th June, 2017)- Polymorph (Form I, II and IV)

US6126971 (Expiry: 19th July, 2013)- Covers stable formulation


US6455574 (Expiry: Aug 11, 2018)- Which covers combination of Atorvastatin + Amlodipine


As per complaint, innovator has sued generic player for the infringement of ‘574 patent.

Probably, Sandoz has filed Para IV with invalidation grounds against ‘574 patent.

Atorvastatin + Amlodipine Besylate (caudet) combination is indicated for the treatment of hypertension and hyperlipidemia

web page statistics
Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
eXTReMe Tracker