Healthcare Industry News: Oxycodone
News Release - April 2, 2007
Purdue Pharma L.P. Announces Agreement to End OxyContin(R) Patent Lawsuit with IMPAX LaboratoriesIMPAX acknowledges validity, enforceability and infringement of Purdue Pharma's OxyContin patents
STAMFORD, Conn., April 2 (HSMN NewsFeed) -- Purdue Pharma L.P. of Stamford, Connecticut and IMPAX Laboratories, Inc. of Hayward, California have agreed to end their lawsuit concerning certain Purdue Pharma patents on OxyContin® (Oxycodone HCl controlled-release) Tablets. Under the terms of the settlement agreement, IMPAX Laboratories acknowledges that Purdue Pharma's OxyContin patents are valid, enforceable and infringed by IMPAX's extended-release Oxycodone products and Purdue agrees it will not pursue damages against IMPAX for past infringement. Purdue also will grant a license to permit IMPAX (through its marketing partner, DAVA Pharmaceuticals) to keep its extended- release Oxycodone products on the market through June 14, 2007, with rights to resume distribution in the future of a limited amount of product for a limited period of time.
The parties will be submitting the agreement to federal antitrust authorities for review and will also submit a consent judgment reflecting certain terms from the agreement to the federal district court in which the action was filed.
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 OxyContinâ Tablets contains the following boxed 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.
Source: Purdue Pharma
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