BARR FILES APPLICATION FOR GENERIC THALOMID

Barr Laboratories has filed an abbreviated new drug application to manufacture and market a generic version of Celgene's Thalomid (thalidomide) capsules, 200 mg.

Thalomid capsules 200 mg had annual sales of approximately $59 million for the 12 months ending in October, according to IMS sales data.

The drug is approved for treating newly diagnosed multiple myeloma in combination with dexamethasone, as well as for the acute treatment of cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

Following receipt of the notice from the FDA, Barr notified Celgene. Celgene indicated that it intends to file a complaint alleging infringement of the patents protecting Thalomid within the required 45-day response period. Celgene is entitled to up to a 30-month injunction against the applicant's marketing of generic thalidomide, according to the company.