Mylan confirms generic Lescol patent challenge

Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis' Lescol(R) Capsules.

Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the product. The company filed an ANDA with the U.S. Food and Drug Administration (FDA) in June. Novartis filed a lawsuit Oct. 10 in the U.S. District Court for the District of New Jersey alleging infringement of U.S. Patent No. 5,354,772.

Fluvastatin Capsules, used in the treatment of high cholesterol, had approximately $60 million in sales for the twelve months ending June 30, 2008, according to IMS Health.

Currently, Mylan has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.

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