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news.Par Pharmaceutical, the generic division of Par Pharmaceutical Companies, has signed a licensing agreement with Glenmark Generics Limited and Glenmark Generics, USA to market Ezetimibe 10mg tablets, the generic version of Merck & Co's Zetia, in the US.
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As per the terms of the licensing and supply agreement, Par Pharmaceutical has made a payment to Glenmark for exclusive rights to commercialise Ezetimibe in the US. The companies are expected to share in profits from the sales of the product.
Zetia is a cholesterol modifying agent used to treat high cholesterol, along with a low-fat, low-cholesterol diet. It is sometimes given with other cholesterol-lowering medications. It is also used to treat high blood sitosterol and campesterol along with diet therapy.
Glenmark believes it is the first to file an ANDA containing a paragraph IV certification for the product. On April 24, 2009, Glenmark was granted tentative approval for its product by the FDA.
Glenmark is currently involved in patent litigation concerning Ezetimibe in the US District Court for the District of New Jersey. Par will share control and costs with Glenmark for ongoing litigation. A trial is scheduled to commence on May 12, 2010.