Mylan has been sued by Pfizer, Wyeth, Wyeth Pharmaceuticals, and PF Prism CV in connection with the filing of an abbreviated new drug application (ANDA) with the US 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.
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 US District Court for District of Delaware.
According to IMS Health for 12 month ending March 31, 2012, Pristiq tablets registered a total sales of approximately $559.4 million.
Currently, Mylan has 169 ANDAs pending FDA approval representing $83.9 billion in annual sales, according to IMS Health. 37 of these pending ANDAs are potential first-to-file opportunities, representing $25.6 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health.
EH News Bureau