BARR CONFIRMS GENERIC THALOMID APPLICATION

Barr Laboratories, a subsidiary of Barr Pharmaceuticals, Dec. 26 confirmed that it is seeking approval from the FDA to manufacture and market a generic version of Celgene Corporation's Thalomid capsules, 50 mg and 100 mg.

Barr filed an abbreviated new drug application (ANDA) containing a Paragraph IV certification for a generic version of Thalomid (thalidomide) capsules with the FDA in September 2006. As originally filed, that ANDA sought approval to manufacture and market the 200-mg strength. The company received notification of the application's acceptance for filing from the FDA on Dec. 5, 2006. Following receipt of the notice from the FDA, Barr notified Celgene, the patent owner and NDA holder. Also in December 2006, the company amended its application to include the 50-mg and 100-mg capsule strengths.

On Dec. 13, 2006, Celgene confirmed it had received notification of Barr's ANDA on file with the FDA containing a Paragraph IV certification for Thalomid capsules, 200 mg. Celgene indicated that it intends to file a complaint alleging infringement of the patents protecting Thalomid capsules, 200 mg, within the required forty-five day response period.

On Nov. 28, 2006, the U.S. Patent and Trade Office issued a new patent for Celgene's Thalomid capsule product. Barr amended its ANDA on file with the FDA to certify against the patent in December 2006. Barr's amendment included a certification that the patent listed in the Orange Book for Thalomid capsules was invalid or would not be infringed by Barr's product. Barr notified Celgene of its challenge to the new patent.

Thalomid Capsules, 50 mg, 100 mg and 200 mg, had annual sales of approximately $424 million for the twelve months ended October 2006, based on IMS sales data.