Watson Provides Update on District Court Order Concerning Generic Version of LOVENOXÃ‚®
PARSIPPANY, N.J., Oct. 8, 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. 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,