Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole Tablets, 50 mg and 200 mg, under a previously announced settlement and license agreement with Pfizer Inc. Mylan was the first company to have filed a substantially complete ANDA containing a Paragraph IV certification for Voriconazole Tablets and was awarded 180 days of marketing exclusivity.
Voriconazole Tablets are the generic version of Pfizer's Vfend® Tablets, a triazole antifungal agent. This product had U.S. sales of approximately $186 million for the 12 months ending Dec. 31, 2010, according to IMS Health.
Currently, Mylan has 170 ANDAs pending FDA approval representing $97.7 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24.2 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health.