Nycomed filed Patent Litigation against Glenmark for fluticasone Propionate lotion

Source confirmed that Nycomed US has filed a patent infringement lawsuit on Dec 12, 2008, in the US District Court

, Eastern District Court of New York regarding Glenmark's abbreviated new drug application for its fluticasone propionate 0.05% lotion product; CUTIVATE^®. There is only one patent listed in OB i.e. US7300669 which expires on Oct 20, 2019; exclusivities for this product has already expired on Mar, 2008 and Sep, 2008

 

Claim of  US7300669

1. A topical lotion, comprising: about 0.005 to 1.0 wt. % fluticasone, or a pharmaceutically acceptable salt or ester thereof; about 4.0 to 6.0 wt. % of a C14-C20 fatty alcohol or mixtures thereof; about 1.0 to 5.0 wt. % of at least one first skin conditioning agent; about 5.0 to 15.0 wt. % propylene glycol; and the balance in water; wherein the lotion is free of mineral oil and white soft paraffin, and wherein the lotion causes more vasoconstriction when applied to living human skin than does application of a cream containing mineral oil or soft white paraffin, or both, the cream containing the same amount of the fluticasone or the pharmaceutically acceptable salt or ester thereof.

Glenmark filed its ANDA containing a paragraph IV certification for a generic version of fluticasone propionate lotion with the US Food and Drug Administration, and following receipt of the notice from the FDA that Glenmark's ANDA had been accepted for filing, Glenmark notified the new drug application 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 at $33 million in the US, based on IMS sales data ending September 2008. On successful patent challenges, Glenmark will be entitled for the 180 days exclusivity.