Singapore, Dec19, 2008: Glenmark Generics’ US subsidiary (GGI) has confirmed that Nycomed US has filed a patent infringement lawsuit on December 12^th 2008 in the US District Court, New York.

 

The lawsuit is 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 to the FDA containing a paragraph IV certification for a generic version of Fluticasone Propionate lotion. After the filing was accepted Glenmark is said to have 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.

 

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.

 

Cutivate 0.05% lotion had annual sales of approximately $33 million in the US, based on IMS sales data ending September 2008.