Mylan gets approval for generic version of Vfend
PITTSBURGH — Mylan has launched a generic drug for fungal infections, the company said Tuesday.
Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent.
The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer.
Mylan was the first company successfully to file with the Food and Drug Administration for approval of generic voriconazole tablets and to include in its application a Paragraph IV certification — a legal assertion that the patents covering Vfend are invalid, unenforceable or won’t be infringed — thus entitling it to 180 days of market exclusivity in which to compete directly with the branded version.