Merck & Co has settled a patent dispute with India’s Glenmark Pharmaceuticals over Zetia, Merck’s top-selling cholesterol drug.
Under the terms of the settlement, Glenmark will be able to begin selling its own generic version of Zetia on 12 December 2016, four months before Merck’s patent expires on 25 April 2017.
Glenmark received US Food and Drug Administration approval for its generic in April. In May, the company licensed its generic to Par Pharmaceuticals, which will market and distribute the generic.
Zetia (ezetimibe) was launched in the US in 2002 and is also one of the two components of a newer cholesterol drug Vytorin. The other component of Vytorin, Zocor, is already available as a generic.
Teva Pharmaceutical Industries, the world’s biggest generic-drug maker, and Mylan Inc are challenging the patent as part of their efforts to sell a generic version of Vytorin.