Dr Reddy's Labs bags USFDA okay for Lenalidomide capsules

Published On 2021-10-19 06:15 GMT | Update On 2021-10-19 06:19 GMT

Hyderabad: Drugmaker, Dr. Reddy's Laboratories Ltd., today announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, 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. Food and Drug Administration (USFDA).

With this approval, Dr. Reddy's is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:

• Multiple myeloma (MM), in combination with dexamethasone.

• MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).

• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

In September 2020, Dr. Reddy's 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 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 is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

"We are pleased with the Agency's approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories. "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Dr Reddy's Labs bags USFDA okay for Lenalidomide capsules

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