Watson Confirms Court Stays Preliminary Injunction
Permits Launch of Generic LOVENOX® -
PARSIPPANY, N.J., Jan. 26, 2012 /PRNewswire via COMTEX/ -- Watson Pharmaceuticals, Inc. WPI +1.49% , today confirmed that the United States Court of Appeals for the Federal Circuit has granted Watson and Amphastar Pharmaceuticals, Inc's request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar's Enoxaparin Sodium Injection, a generic equivalent to Sanofi-aventis' LOVENOX®. The Federal Circuit's Order does not represent a final decision with respect to the merits of the pending appeal or the underlying litigation. Amphastar and Watson plan to launch their Enoxaparin Sodium Injection product immediately.
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.
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.
Forward-Looking Statement
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 September 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 Aventis Pharma A.G.
CONTACTS: Investors:
Patty Eisenhaur
(862) 261-8141
Media:
Charlie Mayr
(862) 261-8030
SOURCE Watson Pharmaceuticals, Inc.