Mylan gains 180-day marketing exclusivity on Pfizer's Vfend generics

Mylan Inc said yesterday 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.

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and maintains one of the industry's broadest and highest quality product portfolios supported by a strong product pipeline. It operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies.

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.