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news.Merck & Co has reached a deal to settle a patent litigation with Par Pharmaceutical Companies' partner, Glenmark Generics Limited and Glenmark Generics US that resolves Glenmark's challenge to Merck's patent covering Zetia (ezetimibe).
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The settlement effectively ends the lawsuit 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. Specifically, Glenmark challenged Merck’s basic compound patent, RE 37,721 (the ‘721 patent) on numerous grounds.
Earlier, on May 3, 2010, Par acquired the exclusive rights to market, sell and distribute generic Zetia (ezetimibe) in the US from Glenmark Generics Limited. The companies are expected to share in profits from the sales of the product.
As per the agreement, Par will be able to launch the product on December 12, 2016 or earlier under certain circumstances, ahead of the April 25, 2017 expiration of Merck’s patent exclusivity for Zetia.
The settlement agreement is subject to review by the Federal Trade Commission, the US Department of Justice, and the Attorney General for the State of New Jersey.