The drug major on Wednesday announced the launch of Lenalidomide capsules in the US market with an approval from the US Food and Drug Administration (USFDA).
The said drug is the therapeutic equivalent generic version of Revlimid (lenalidomide) capsules.
Lenalidomide is an anti-cancer medication. It is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS).
The pharmaceutical company said with this volume-limited launch, the company is eligible for first-to-market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.
Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories, said, We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity. Bringing a more affordable generic version to market creates greater patient access for this important drug.
As previously announced, Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. in settlement of all outstanding claims of its litigation. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy's is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on 31 January 2026, the drug maker stated in press release.
Dr. Reddy's Laboratories is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.
The drug major's consolidated net profit surged 108% to Rs 1,187.6 crore on 6% rise in net sales to Rs 5,215.40 crore in Q1 FY23 over Q1 FY22.
Shares of Dr. Reddy's Laboratories were up 0.37% at Rs 4,267 on the BSE.
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