The drug major announced that one of its wholly owned subsidiaries has received final approval from USFDA for its abbreviated new drug application (ANDA) for generic lenalidomide capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.
Lenalidomide capsules are used to treat patients with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes, as a maintenance therapy following stem cell transplant. It is equivalent to reference product, Revlimid capsules.In June 2021, Sun Pharma had entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding Sun Pharma's generic lenalidomide capsules. Pursuant to the terms of this settlement, Celgene granted Sun Pharma a license to Celgene's patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning 31 January 2026.
Sun Pharmaceutical Industries is engaged in the business of manufacturing, developing and marketing a wide range of branded and generic formulations and Active Pharmaceutical Ingredients (APIs)
The company's consolidated net profit rose 5.2% to Rs 2,166.01 on 13.1% jump in net sales to Rs 11,100.14 crore in Q3 FY23 over Q3 FY22.
The scrip was down 0.02% to Rs 1,006.60 on the BSE.
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