In connection with the agreement, Purdue has agreed to grant Mallinckrodt a royalty-bearing license to sell limited quantities of generic versions of 10mg, 20mg, 40mg, and 80mg extended-release oxycodone tablets for a limited period of time ending in 2009.
As a result, Mallinckrodt expects to begin selling oxycodone hydrochloride extended-release tablets before the end of September 2008.
As required by statute, the agreement is subject to review by the Federal Trade Commission and the Antitrust Division of the Department of Justice.
The announcement follows the FDA approval of Mallinckrodt’s abbreviated new drug application for oxycodone hydrochloride extended-release tablets in 10mg, 20mg, 40mg and 80mg dosage strengths, which was obtained on July 24, 2008. Mallinckrodt’s oxycodone hydrochloride extended-release (ER) tablets are the generic pharmaceutical equivalent to OxyContin.
Chuck Bramlage, president of pharmaceutical products at Covidien, said: “The launch of our oxycodone hydrochloride ER tablets is an important milestone that reinforces Covidien’s commitment to developing products for pain management.”