19 October 2021 - Dr. Reddy’s Laboratories today announced the final approval of its abbreviated new drug application for lenalidomide 2.5 mg & 20 mg capsules and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of Revlimid (lenalidomide) capsules, from the U.S. FDA.
With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for lenalidomide 2.5 mg and 20 mg capsules.