For Immediate Release

Contact: Timothy F. Bannon
(203) 588-8450

 

 

Purdue Comments on Federal Court of Appeal

Decision on OxyContin Patent Litigation

 

Stamford, CT - June 8th, 2005 - On June 7th, 2005, a panel of three judges of the United States Court of Appeals for the Federal Circuit upheld a U.S. District Court’s decision from January 2004 that certain of Purdue’s patents for OxyContin® (oxycodone HCl controlled release) Tablets could not be enforced.  Following the decision, Endo Pharmaceutical Holdings Inc. announced that it would immediately launch generic versions of all four strengths of OxyContin.

 

Purdue Pharma believes that its patents were properly obtained and are enforceable.  Accordingly, the company will promptly seek a rehearing of this decision by all twelve appellate court judges.

 

“In our opinion, and that of our legal advisers, this decision is contrary to principles of patent law established by the Federal Circuit as well as by the Supreme Court of the United States,” said Howard Udell, Executive Vice President and Chief Legal Officer at Purdue.

 

“While we are disappointed with this outcome, we have taken certain precautionary steps to prepare for the possibility of such a decision,” said Michael Friedman, President and CEO of Purdue.  “We intend to continue the production and sale of our branded OxyContin product line.  Additionally, as part of our contingency planning, we have entered into an agreement with IVAX Pharmaceuticals that allows IVAX to distribute authorized generic versions of OxyContin Tablets in all four strengths.  This will enable Purdue to introduce a quality product in the growing generic segment of the $2 billion oxycodone extended-release product category.” 

 

The company is actively engaged in discussions with a number of other pharmaceutical companies to add other medications to its product portfolio. 

 

The professional product labeling for OxyContinâ 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.

 

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