Friday, August 20, 2010

Merck Sues Impax For Infringement, After Impax Files FDA Papers To Market Generic Version Of Vytorin®

Well, it is past time to update my Merck patent cliff chart, anyway (see my next post, for that) -- and here's a $1 billion reason to do so.

Moreover, with comparative effectiveness testing due in the US by about the same time, Vytorin® may be effectively "out-of-runway", before IMPROVE-IT is published in mid-2014 (as I predicted on April 2, 2010). So ends the would be dynasty. A sincere hat tip to theflyonthewall online data aggregator:

. . . .Impax confirms patent challenge relating to Vytorin

Impax Laboratories has initiated a challenge of patents listed by MSP Singapore Co. LLC in connection with Vytorin, 10 mg/80 mg. Impax filed its ANDA containing a paragraph IV certification for a generic version of Vytorin with the FDA. Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification. On August 19, 2010, Schering Corporation and MSP Singapore Co. LLC filed suit for patent infringement against Impax in the United States District Court for the District of New Jersey. This action formally initiates the patent challenge process under the Hatch-Waxman Act. Once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products. . . .

[Editors' Subsequent Note: In July 2010, New Merck also sued Mylan, and Teva, for infringement of similar patents, covering the ezetimibe portion of this combo pill -- ezetimibe is presently sold as Zetia®, around the world by New Merck.] Although Vytorin was a $1.8 billion franchise this year -- by about November 19, 2013, or 39 months from now -- it may well be all but gone, due to generic competition.

So, even if, by dint of some dark miracle, IMPROVE-IT is published by mid-2013 -- and reaches a favorable outcome -- after New Merck/Schering-Plough's 0-for-4 record (albeit in other, smaller studies), it likely won't matter -- for more than five months, from June to November, 2013. And remember, it is actually far more likely that IMPROVE-IT won't be published until mid 2014.

Game (effectively) over.

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