Celgene Corp said it plans to file a complaint alleging infringement against India's Natco Pharma Ltd, which has submitted a request to the US Food and Drug Administration for authorization to make and sell generic versions of Celgene's cancer drug Revlimid in the United States.
Celgene said it intends to vigorously enforce its intellectual property rights for Revlimid, its most important drug, and will file the complaint within the required 45-day response period.
Natco's Abbreviated New Drug Application submitted to the FDA requests authorization to make the drug in 5, 10, 15, and 25 milligram capsules.
Revlimid is currently protected by 12 issued patents listed in the FDAs Approved Drug Products List and has additional patent applications pending, Celgene said.
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