Merck settles Zetia patent suit, allowing early generic release

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Merck and Glenmark Pharmaceuticals have reached an agreement to settle their patent litigation involving Glenmark's challenge to Merck's patent covering Zetia (ezetimibe).

Glenmark, headquartered in Mumbai, India, challenged Merck's basic compound patent, RE 37,721 (the ‘721 patent) on numerous grounds. Under the agreement, Glenmark will be able to launch their product on Dec. 12, 2016, or earlier under certain circumstances, ahead of the April 25, 2017, expiration of Merck's patent exclusivity for the cholesterol drug Zetia.

According to the Whitehouse Station, N.J.-based Merck, this settlement effectively ends the lawsuit that was scheduled to begin on May 12, involving a challenge by Glenmark, which sought to launch a generic version of Zetia before the April 2017 expiration of the patent exclusivity covering Zetia.