May 4, 2010 – A deal has been struck to produce a generic version of Merck & Company’s Zetia (ezetimibe). In the United States, the cholesterol modifying agent has annual U.S. sales of about $1.4 billion, according to IMS Health data.
Par Pharmaceutical Inc. yesterday announced it entered into an exclusive licensing agreement with Glenmark Generics to market ezetimibe 10 mg tablets. Glenmark believes it is the first to file a U.S. Food and Drug Administration (FDA) abbreviated new drug application (ANDA) for generic drug approval of the pharmaceutical. The ANDA includes a paragraph IV certification for the product, which would potentially provide 180 days of marketing exclusivity. In April 2009, Glenmark was granted tentative approval for its product by the FDA.
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 United States. The companies will share in profits from the sales of the product.
Glenmark is currently involved in patent litigation concerning the drug in the U.S. 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 May 12.
Par Pharmaceutical is a U.S.-based specialty pharmaceutical company. It develops, manufactures and markets generic drugs and niche proprietary pharmaceuticals.
For more information: www.parpharm.com