FDAnews Drug Daily Bulletin

IMPAX'S GENERIC OXYCONTIN TO BE DISTRIBUTED BY DAVA

Nov. 16, 2005
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IMPAX Laboratories has signed a supply and distribution deal under which DAVA Pharmaceuticals will market IMPAX's oxycodone HCl extended-release tablets in the U.S. and Puerto Rico.

The 10-year agreement calls for DAVA to have exclusive sales of distribution rights to IMPAX's oxycodone tablets in 10-, 20-, 40- and 80-mg dosage strengths. IMPAX's products are the generic equivalent of Purdue Pharma's pain drug OxyContin.

IMPAX had been marketing its 80-mg product through its global pharmaceutical division, but will be transitioning sales and marketing responsibilities to DAVA. IMPAX currently has a tentative abbreviated new drug application (ANDA) approval for the 10-, 20- and 40-mg dosage strengths with final approval subject to the expiration of Endo Pharmaceuticals market exclusivity on Dec. 5. Endo launched its generic OxyContin products in June.

The combined branded and generic U.S. sales for the 10-, 20-, 40- and 80-mg strengths of oxycodone hydrochloride extended release tablets were more than $1.8 billion for the 12-month period ended Aug. 31, according to NDCHealth.