Endo Pharmaceuticals Holdings Inc, a market leader in pain management, announced that it has decided at this time to launch its 10mg, 20mg and 40mg strengths oxycodone extended-release tablets after the appellate court decision.

Endo's oxycodone extended-release tablets are AB-rated bioequivalent versions of the same strengths of OxyContin, a product of The Purdue Frederick Company that is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.

The company remains confident that the District Court decision declaring Purdue's OxyContin patents invalid will be affirmed by the Federal Circuit Court. The company will continue to monitor the situation and may in the future decide to launch its oxycodone extended-release tablets in advance of the appellate court decision. Endo will have 180 days of marketing exclusivity with respect to the 10mg, 20mg and 40mg strengths at the earlier of the launch of these strengths or a favorable appellate court decision, since the company was the first applicant to file an ANDA containing a Paragraph IV certification for these dosages.

As previously announced on March 24, 2004, the U.S. Food and Drug Administration (FDA) granted final approval of Endo's abbreviated new drug application (ANDA) for oxycodone extended-release tablets, 10mg, 20mg and 40mg. Final FDA approval followed an Opinion and Order issued by the U.S. District Court for the Southern District of New York, as announced on January 5, 2004, dismissing the claims that Endo's oxycodone extended-release tablets, 10mg, 20mg, 40mg, and 80mg, infringe Purdue's U.S. Patent Nos. 5,549,912, 5,508,042 and 5,656,295, declaring the patents invalid, and enjoining Purdue from enforcing the patents.

The FDA has confirmed Endo's marketing exclusivity period and has reaffirmed its tentative approval for Endo to market the 80mg strength, which will be granted final approval upon the expiration of another company's 180 days of marketing exclusivity on this strength.

On January 12, 2004, Purdue filed a Notice of Appeal in the United States District Court for the Southern District of New York, petitioning the United States Court of Appeals for the Federal Circuit to overturn the District Court's January 5, 2004 ruling. Because an appeal is pending, Endo would be launching these products at risk of damages payable to Purdue, potentially for Purdue's lost profits, should the District Court's decision be overturned.