Mumbai-headquartered Sun Pharmaceutical Industries Ltd on Friday said that one of its wholly-owned subsidiaries had received final approval from the United States Food and Drug Administration (USFDA) for generic medication used in the treatment of different types of cancer, including multiple myeloma.
NSE
In a filing to the stock exchanges, the company said it had received final approval for its Abbreviated New Drug Application (ANDA) for generic lenalidomide capsules, 5mg, 10mg, 15mg, 25mg, and tentative approval for 2.5mg, 20mg.
This approved product is a generic version of Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg.
In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding Sun Pharma's generic lenalidomide capsules. Under the terms of this settlement, Celgene granted Sun Pharma a licence to Celgene's patents required to manufacture and sell specific limited quantities of generic lenalidomide capsules in the US beginning sometime after March 2022. Further, the licence allows Sun Pharma to manufacture and sell an unlimited amount of generic lenalidomide capsules in the US starting January 31, 2026.
Other drug majors such as Dr Reddy's Laboratories, Cipla and Natco have launched Revlimid generic in the US.
Sun Pharmaceutical's consolidated net profit for Q3FY23 rose five percent year-on-year to Rs 2,166 crore from Rs 2,058.8 crore.
The company's quarterly revenue increased 15 percent year-on-year to Rs 11,241 crore. The figure was higher than the CNBC-TV18 poll of Rs 11,180.5 crore. Net profit too was marginally higher than the expectations of Rs 2,138.3 crore.
Sun Pharmaceutical Industries Ltd stock traded 0.25 percent lower at Rs 1004.25 apiece on BSE at 12:55 PM on Friday.