The Hindu Business Line : Nycomed files patent suit against Glenmark

Mumbai, Dec. 17 Drug-firm Nycomed has filed a patent infringement suit in the US District Court regarding Glenmark’s generic version for its Fluticasone Propionate skin lotion.

Nycomed markets its Fluticasone product as Cutivate and the annual sales of the product is estimated at $33 million in the US, according to industry data.

With this filing, Glenmark has three products currently under litigation — the other two molecules being cholesterol drug Ezetimibe and hypertension medicine Trandolapril+Verapamil Hydrochloride.

Glenmark filed a paragraph IV certification (that involves a patent challenge) for a generic version of Fluticasone Propionate lotion with regulator, the US Food and Drug Administration (FDA).

After getting the notice from the FDA that Glenmark’s filing had been accepted, Glenmark notified the New Drug Application (NDA) holder and patent owner, a note from the company said, detailing the process of patent challenges as required by the US law — 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,” the company said.

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