CORONA, Calif., Oct. 18 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that, under a supply agreement with Purdue Pharma L.P., Watson has been appointed as the exclusive distributor of authorized generic oxycodone HCl controlled-release tablets C-II in 10, 20, 40 and 80 mg dosage strengths. Oxycodone HCl is the generic version of Purdue’s OxyContin(R) (C-II) Tablets, a narcotic analgesic indicated for the treatment of moderate to severe pain for patients in need of a continuous round-the-clock analgesic for an extended period of time. For the 12-months ending August 2005, OxyContin and generic equivalents had sales of approximately $2.0 billion, according to IMS Health data.
Under the terms of the supply agreement, Purdue will manufacture and supply the Oxycodone HCl tablets to Watson, which will market, sell and distribute the generic product in the United States. Purdue will receive a share of the profits from Watson’s sales of the generic product in the U.S. market. Watson expects to launch the product shortly. Further details on the agreement have not been disclosed.
The professional product labeling for Oxycodone HCl Controlled-Release Tablets contains the following boxed warning:
WARNING: Oxycodone HCl Controlled-Release Tablets are an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Oxycodone HCl Controlled-Release Tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Oxycodone HCl Controlled-Release Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. Oxycodone HCl Controlled-Release Tablets are NOT intended for use as a prn analgesic. OXYCODONE HCl CONTROLLED-RELEASE 80 MG TABLETS ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. This tablet strength may cause fatal respiratory depression when administered to patients not previously exposed to opioids. OXYCODONE HCl CONTROLLED-RELEASE TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OXYCODONE HCl CONTROLLED-RELEASE TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE. About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, California, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceutical’s Web site at http://www.watsonpharm.com.
Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson’s current expectations depending upon a number of factors affecting Watson’s business. These factors include, among others, the impact of competitive products and pricing, market acceptance of and continued demand for Watson’s products, difficulties or delays in manufacturing; and 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, 2004 and Form 10-Q for the period ended June 30, 2005.
OxyContin(R) is a registered trademark of Purdue Pharma, L.P.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/