Barr Laboratories Inc., a subsidiary of Barr Pharmaceuticals, Inc. has confirmed that it is seeking approval from the US Food & Drug Administration (FDA) to manufacture and market a generic version of Celgene Corporation's Thalomid (thalidomide) 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 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 December 5, 2006. Following receipt of the notice from the FDA, Barr notified Celgene, the patent owner and New Drug Applications (NDA) holder. Also in December 2006, the company amended its application to include the 50 mg and 100 mg capsule strengths.

On December 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 November 28, 2006, the US Patent and Trade Office (PTO) 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.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.