PARSIPPANY, N.J., Sept. 19, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that Amphastar Pharmaceuticals, Inc., has received U.S. 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 U.S. retail pharmacy channel. Amphastar will receive between 50 and 55 percent 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 U.S. 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.
About Watson Pharmaceuticals, Inc.
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. Watson has operations in many of the world's established and growing international markets.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
About Amphastar Pharmaceuticals, Inc.
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.
Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. Actual results may differ materially from Watson's current expectations depending upon a number of factors, risks and uncertainties affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products; and such other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's quarterly report on form 10-Q for the quarter ended June 30, 2011 and Watson's annual report on Form 10-K for the year ended December 31, 2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
LOVENOX® is a registered trademark of Sanofi-aventis U.S. LLC.
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SOURCE Watson Pharmaceuticals, Inc.