STAMFORD, Conn., Nov. 27 /PRNewswire-FirstCall/ -- Purdue Pharma L.P. today announced that IMPAX Laboratories, Inc. and its distributor DAVA Pharmaceuticals will resume sales of a limited amount of IMPAX’s generic version of Purdue’s OxyContin(R) (oxycodone HCl extended-release) Tablets on November 27, 2007 pursuant to the agreement the companies signed on March 30, 2007 to resolve then pending patent litigation. IMPAX sales of its generic product are expected to continue until the earlier of January 28, 2008, or until the company’s sales quota under its license agreement with Purdue has been reached.
Under the terms of the March 30, 2007 settlement agreement, IMPAX Laboratories acknowledged that Purdue’s OxyContin patents are valid, enforceable and infringed by IMPAX’s extended-release oxycodone. Purdue in turn granted a limited license permitting IMPAX and its marketing partner, DAVA Pharmaceuticals, to keep its extended-release oxycodone on the market through June 14, 2007 and to resume distribution at a future date of a limited amount of product for a limited period of time. Further terms of the agreement were not disclosed.
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(R) 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/PI/Prescription/Oxycontin.pdf.
CONTACT: James Heins of Purdue Pharma L.P., +1-203-588-8069
Web site: http://www.purduepharma.com/
http://www.purduepharma.com/PI/Prescription/Oxycontin.pdf/
