CELGENE SUES BARR OVER GENERIC THALOMID

Celgene has filed a patent infringement lawsuit in federal court to block the manufacturing and marketing of generic Thalomid, Barr Laboratories said.

Celgene filed the suit in the U.S. District Court for the District of New Jersey after being notified of an abbreviated new drug application (ANDA) submitted by Barr seeking FDA approval to produce generic Thalomid (thalidomide) in 200-mg capsules.

Celgene markets Thalomid capsules in 50-, 100- and 200-mg doses and it owns seven patents related to the administration and use of the drug in treating cancer, according to company President Robert Hugin.

Barr filed its ANDA last September to market generic Thalomid in 200-mg capsules. It amended that application last month with a request to market the drug in 50- and 100-mg strengths.

Thalomid capsules in 50-, 100-, and 200-mg doses had annual sales of approximately $417 million for the 12 months ended November 2006, according to IMS Health sales data.