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Watson Reaches Settlement with Mallinckrodt Over Exalgo(R)

PARSIPPANY, N.J., Jan. 26, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc.- Florida has reached a settlement with Mallinckrodt Inc. on outstanding patent litigation related to Watson's generic versions of Mallinckrodt's Exalgo® (Hydromorphone Hydrochloride Extended-Release ) tablets.  Mallinckrodt filed its lawsuit on December 10, 2010 in the United States District Court for the District of New Jersey following Watson's filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its product in the 8 mg, 12 mg, and 16 mg dosage strengths.

Under terms of the settlement agreement, Mallinckrodt has granted Watson a royalty-free license to U.S. patents relating to Exalgo®.  Watson will have the right to launch its bioequivalent products on November 15, 2013.  Other details of the settlement were not disclosed.

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Exalgo® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

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.

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 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.

Exalgo® is a registered trademark of Mallinckrodt LLC.

CONTACTS:

Investors:

 

Patty Eisenhaur

 

(862) 261-8141

 

 

 

Media:

 

Charlie Mayr

 

(862) 261-8030

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SOURCE Watson Pharmaceuticals, Inc.