Wednesday, April 8, 2009

Six Firms May Still Launch A Generic Version of Clarinex in 2009. . . .


While a few generic pharma-makers have settled with Schering-Plough in the last few months, it is still true that at least six such makers remain -- (including India's Orchid) -- see older scheduling order image, at right, but now remove Mylan and GeoPharma as parties, given the intervening announcements. [More background on the various patent claims and counterclaims, here.]

Per Forbes:

. . . .Mylan Inc. said Wednesday it settled a patent lawsuit brought by Schering-Plough Corp., and will be able to start selling a generic version of the allergy drug Clarinex on July 1, 2012.

Under the agreement, Mylan will be allowed to market 5 mg tablets of desloratadine, the active ingredient in the drug, providing its version receives approval from the Food and Drug Administration. . . . Mylan will be able to launch its drug before July 2012 under certain conditions [including if FDA approves its ANDA prior to that time]. . . .

Should be entertaining -- as fact discovery should be ordered closed any day now, by New Jersey federal District Court Judge Toni Bongiovanni, and trial prep should begin in earnest. So -- will there be an at-risk generic launch in 2009? [The branded franchise drug is still worth over $750 million a year in sales to Schering.] My best-guess candidate to do so would be Orchid Pharmaceuticals, out of India. We'll have to wait and see.

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