Pozen (POZN) Receives Notice from Dr. Reddy's Labs (RDY) Indicating Dr. Reddy's has Filed an ANDA to Market a Generic Version of Treximet
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In a Form 8-K, Pozen (Nasdaq: POZN) announced that on July 31, 2009, the company received a notice from Dr. Reddy’s Laboratories, Inc. (NYSE: RDY) pursuant to 21 U.S.C. 355(j)(2)(A)(vii)(IV) indicating that Dr. Reddy’s had filed an Abbreviated New Drug Application with the U.S. FDA seeking regulatory approval to market a generic version of Treximet® before the expiration of U.S. Patent Nos. 6,060,499, 6,586,458 and 7,332,183. These patents are assigned to POZEN and listed with respect to Treximet® in the FDA’s Approved Drug Products with Therapeutic Equivalents Evaluation publication. In its Paragraph IV Notice Letter, Dr. Reddy’s asserts that its generic product will not infringe the listed patents or that the listed patents are invalid. POZEN is currently evaluating Dr. Reddy’s Paragraph IV Notice Letter.
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