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.