Mylan Confirms First-to-File Patent Challenge Relating to Pristiq Tablets
Mylan Inc. (Nasdaq: MYL) today confirmed that the company has been sued by Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg. This product is the generic version of Pfizer's Pristiq® Tablets, which are indicated for the treatment of major depressive disorder (MDD) in adults.(1)
Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for both strengths and expects to share 180 days of marketing exclusivity upon final FDA approval. The plaintiffs filed the lawsuit in the U.S. District Court for District of Delaware.
For the 12 months ending March 31, 2012, Pristiq Tablets had total sales of approximately $559.4 million, according to IMS Health.
Currently, Mylan has 169 ANDAs pending FDA approval representing $83.9 billion in annual sales, according to IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $25.6 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
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