Thursday 18 December, 2008

Cutivate (Fluticasone propionate): Innovator sued Glenmark generics for filing ANDA with Para IV certification

Innovator Nycomed U.S. has filed a patent infringement lawsuit in the United States against Glenmark Generics, after receipt of Para IV notice letter from Glenmark on generic version of Nycomed's Cutivate (Fluticasone propionate) skin lotion. Glenmark has filed ANDA with Para IV certification against following Orange Book listed patent:
US7300669 (Assignee: Altana, Issued on: November 27, 2007 , Expiry: Oct 20, 2019): Which covers 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.
Innovator Nycomed got approval for this product on March 31, 2005.
Fluticasone propionate is a steroid having anti-inflammatory, anti-pruitic, and vasoconstrictive properties

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