PARSIPPANY, N.J., Oct. 8, 2011 /PRNewswire via COMTEX/ -- Watson Pharmaceuticals, Inc. today confirmed that the United States District Court for the District of Massachusetts has granted a request by Momenta Pharmaceuticals, Inc. and Sandoz Inc. for a temporary restraining order (TRO) preventing Watson and Amphastar Pharmaceuticals, Inc. from marketing or selling Amphastar's Enoxaparin Sodium Injection product, a generic equivalent to Sanofi-aventis' LOVENOX®. The temporary restraining order expires on October 21, 2011. During the hearing on the TRO, the court made no finding concerning plaintiffs' likelihood of success on the merits of their claim. However, in its written order, the court found the plaintiffs had demonstrated a likelihood of success on the merits for the purpose of the TRO. The court scheduled a full hearing on the merits of Momenta and Sandoz's motion for a preliminary injunction for October 20, 2011. Watson expects to launch the product during the fourth quarter of 2011 if the plaintiffs' request for a preliminary injunction is denied.
Enoxaparin 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.
On September 19, 2011, Amphastar received U.S. Food and Drug Administration ("FDA") approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection in the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL, 100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths. Watson has the exclusive right to distribute Amphastar's Enoxaparin in the U.S. retail pharmacy channel.
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.
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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 difficulty of predicting the timing and outcome of the pending patent litigation and risks that an adverse outcome in such litigation could render Watson liable for substantial damages; 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.