Par announces tentative approval of generic ribavirin

By Jennifer Chiou

New York, Oct. 20 - Par Pharmaceutical Cos., Inc. said marketing partner Three Rivers Pharmaceuticals was granted tentative approval by the U.S. Food and Drug Administration for its abbreviated new drug application for a generic version of ribavirin in 200 mg, 400 mg and 600 mg tablets.

Ribavirin, a synthetic nucleoside analog with antiviral activity, is used with peginterferon alfa-2a for hepatitis C.

Roche Pharmaceuticals markets ribavirin tablets under the brand name Copegus and annual U.S. sales are about $200 million.

Par said it expects final approval of ribavirin after the expiration of Copegus' exclusivity on Dec. 3. Under the agreement with Three Rivers, Par will co-market Three Rivers' ribavirin tablets and the companies will split profits.

Spring Valley, N.Y.-based Par Pharmaceutical develops and markets generic pharmaceuticals.

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