Dr Reddy's Laboratories gets a USFDA nod on Lenalidomide capsules

Dr Reddy's Laboratories received the final approval of its Abbreviated New Drug Application for Lenalidomide capsules (in 2.5 mg and 20 mg) and tentative approval (for 5 mg, 10 mg, 15 mg and 25 mg) from the United States Food and Drug Administration.

With this approval, Dr Reddy's Laboratories is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg. In September 2020, the pharmaceutical major announced a settlement agreement of their litigation with Celgene, the maker of Revlimid (Lenalidomide) capsules and a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr Reddy's Laboratories with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential. As part of the settlement, Dr Reddy's Laboratories is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on 31 January 2026.

The company's consolidated net profit declined by 36% to Rs 380.40 crore on a 11.4% rise in net sales to Rs 4,919.40 crore in Q1 FY22 over Q1 FY21.

Shares of Dr Reddy's Laboratories rose 0.17% to Rs 4,882.25 on BSE. Dr Reddy's Laboratories is an integrated pharmaceutical company. Through its three businesses - pharmaceutical services & active ingredients, global generics and proprietary Products.

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