Healthcare Industry News:  Oxycodone 

Biopharmaceuticals Generics Litigation

 News Release - October 16, 2006

Purdue Pharma L.P. Announces Signing of Consent Judgment Ending OxyContin(R) Tablets Patent Lawsuit with Teva Pharmaceuticals

Teva admits Purdue Pharma's OxyContin patents are valid, enforceable and infringed

STAMFORD, Conn., Oct. 16 (HSMN NewsFeed) -- The patent litigation between Purdue Pharma L.P. of Stamford, Connecticut and Teva Pharmaceuticals USA, Inc. of North Wales, Pennsylvania concerning certain Purdue Pharma patents on OxyContin® (Oxycodone HCl controlled-release) Tablets ended on Thursday, October 12 with the signing of a Consent Judgment in the United States District Court for the Southern District of New York. In the Consent Judgment, Teva admits that Purdue Pharma's OxyContin patents are valid, enforceable and infringed by Teva's extended-release Oxycodone products.

On August 29, 2006 Purdue Pharma and Teva announced their agreement to terminate the litigation subject to certain contingencies, including review by the United States antitrust agencies and the United States District Court for the Southern District of New York. The agreement permits Teva to continue sales of its generic version of OxyContin at least through March 31, 2007.

"We worked for years to invent an important medicine and lawfully obtained the patents necessary to protect it from infringers. We are pleased that Teva has acknowledged our innovation as well as our rights to enforce our patents," said Michael Friedman, President and CEO of Purdue Pharma. "We will continue to enforce our patents vigorously against all infringers."

"We will continue to be innovators, constantly looking for new products to serve physicians and the patients in their care," Friedman concluded.

Purdue Pharma has filed infringement actions to protect its OxyContin patents against other companies. On February 1, 2006, the United State Circuit Court of Appeals for the Federal Circuit ruled the Purdue patents to have been infringed by extended-release Oxycodone products sold by Endo Pharmaceuticals Inc. of Chadds Ford, Pennsylvania.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

The professional product labeling for OxyContin® Tablets contains the following boxed warning:

WARNING:

OxyContin is 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 OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

OxyContin 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.

OxyContin Tablets are NOT intended for use as a prn analgesic.

OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF Oxycodone.

Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF.


Source: Purdue Pharma

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