Watson Pharmaceuticals, Inc. announced that Amphastar Pharmaceuticals, Inc., has received US Food and Drug Administration (FDA) approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin sodium injection in the 100mg/mL and 150mg/mL strengths. Enoxaparin sodium injection is the generic equivalent to sanofi-aventis' Lovenox, and is a low molecular weight heparin indicated in the prophylaxis and treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.
Pursuant to the terms of the parties' exclusive Distribution Agreement, Amphastar will supply Enoxaparin sodium injection to Watson, which will market, sell and distribute the product to the US retail pharmacy channel. Amphastar will receive between 50 and 55 per cent of Watson's gross profits on product sales, depending on the number of competitors in the market. Amphastar will market, sell and distribute the product to all other channels. For the 12-months ending July 30, 2011, Lovenox and its generic equivalents had total US sales of approximately $2.6 billion, according to IMS Health. Amphastar is currently preparing for launch and anticipates launching its Enoxaparin Sodium Injection product in the fourth quarter of 2011.
Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health.
Amphastar Pharmaceuticals, Inc., established in 1996, is a specialty and generic pharmaceutical company focusing on injectable, inhalation, and other categories of pharmaceutical products. Amphastar's state-of-the-art, aseptic, cGMP compliant facilities develop, manufacture, and market innovative proprietary and generic products using new technologies and delivery systems.