Par Pharmaceutical Companies, Inc announced that its generic division, Par Pharmaceutical, has entered into an exclusive licensing agreement with Glenmark Generics Limited and Glenmark Generics Inc, USA to market ezetimibe 10 mg tablets, the generic version of Merck & Co Inc's Zetia, in the US. Zetia is a cholesterol modifying agent with annual US sales of approximately US$ 1.4 billion, according to IMS Health data. Glenmark believes it is the first to file an ANDA containing a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity. On April 24, 2009, Glenmark was granted tentative approval for its product by the US Food and Drug Administration.
Under the terms of the licensing and supply agreement, Par has made a payment to Glenmark for exclusive rights to market, sell and distribute ezetimibe in the US. The companies will share in profits from the sales of the product.
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.
Par Pharmaceutical is a US-based specialty pharmaceutical company. Through its wholly-owned subsidiary's two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.