Glenmark Confirms Patent Challenge of Fluticasone Lotion
Glenmark Generics Ltd’s US subsidiary(GGI) confirmed Nycomed US (”Nycomed”) filed a patent infringement lawsuit on 12 Dec 2008 in the U.S. District Court, Eastern District Court of New York regarding Glenmark’s Abbreviated New Drug Application (”ANDA”) for its Fluticasone Propionate 0.05% Lotion product. Nycomed currently markets its Fluticasone product as CUTIVATE®.
Glenmark filed its ANDA containing a paragraph IV certification for a generic version of Fluticasone Propionate lotion with the U.S. Food & Drug Administration (FDA), and following receipt of the notice from the FDA that Glenmark’s ANDA had been accepted for filing, Glenmark notified the New Drug Application (NDA) holder and patent owner.
Nycomed’s lawsuit is part of the patent challenge process under the Hatch-Waxman Act. Based on the information published by the FDA, Glenmark believes it may be the first applicant to have filed an ANDA for this product with a paragraph IV certification. In the event that Glenmark successfully challenges Nycomed’s patent, Glenmark will be entitled to a 180-day exclusivity period.
CUTIVATE (Fluticasone Propionate) 0.05% Lotion had annual sales of approximately USD 33 million in the U.S., based on IMS sales data ending September 2008.
With this filing, Glenmark has three products currently under litigation under the Hatch-Waxman Act. The earlier two molecules are Ezetimibe and Trandolapril+Verapamil Hydrochloride . On successful patent challenges, Glenmark will be entitled for the 180 days exclusivity.
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