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Barr seeks approval for generic Thalomid

Celgene Corporation has indicated its intention to defend its patent for Thalomid after Barr Pharmaceuticals submitted an application to the FDA to market a generic version of the drug as a leprosy treatment.

Barr is seeking authorization to market a generic version of Thalomid 200mg tablets in the US. Celgene has approval to market Thalomid as a treatment in combination with dexamethasone for newly diagnosed multiple myeloma patients as well as for leprosy complications. The key ingredient in the medicine, thalidomide, was once banned for causing birth defects.

Celgene said it intends to vigorously protect and defend its intellectual property rights against the infringement.

Celgene intends to file a complaint alleging infringement of Celgene patents, within the required forty-five day response period. By bringing suit, Celgene is entitled to up to a 30-month injunction against the applicant’s marketing of generic thalidomide.