Watson Confirms District Court Order Concerning Generic Version of LOVENOX(R)
PARSIPPANY, N.J., Oct. 7, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) 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. In entering the TRO, the court made no finding concerning plaintiffs' likelihood of success on the merits of their claim. A hearing on Momenta and Sandoz's motion for a preliminary injunction is expected to be held on October 20, 2011. Watson expects to launch the product during the fourth quarter of 2011 if the 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.
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