Watson Pharmaceuticals, Inc.'s Generic BONIVA(R) 150mg Receives FDA Approval
Published: Mar 21, 2012
PARSIPPANY, N.J., March 20, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc. has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Ibandronate 150mg tablets, the generic equivalent to Roche's BONIVA® tablets. Watson intends to begin shipping the product in the second quarter. BONIVA® 150mg tablets had total U.S. sales of approximately $510 million for the twelve months ending January 31, 2012, according to IMS Health. Ibandronate tablets are indicated to prevent and treat osteoporosis in women who have undergone menopause. Roche has sued Watson for patent infringement in connection with Watson's ANDA for Ibandronate 150mg tablets. That lawsuit remains pending.
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.
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 annual report on Form 10-K for the year ended December 31, 2011. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
BONIVA® is a registered trademark of Roche Therapeutics, Inc.
SOURCE Watson Pharmaceuticals, Inc.