Mylan debuts Lescol copy; Impax challenges Gralise patent

16 April 2012

US generic drug major Mylan (Nasdaq: MYL) revealed last Friday that it has begun shipping its generic version of the lipid-lowerer Lescol (fluvastatin), after its subsidiary Mylan Pharmaceuticals received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for fluvastatin capsules USP, 20mg and 40mg, the first generic copy of the branded product from Swiss pharma major Novartis (NOVN: VX).

This product is indicated for the treatment of both familial and non-familial hypercholesterolemia and mixed dyslipidemia. It is also indicated for the secondary prevention of cardiovascular disease. The Lescol brand generated US sales of $27.9 million in 2011.

Under a settlement and license deal with Novartis, Mylan was granted rights to launch a copy of fluvastatin prior to the expiration of the pediatric exclusivity associated with US Patent No 5,356,896, which expires on June 12, 2012.

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