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.

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.