Dr. Reddy’s has obtained the Food and Drug Administration's approval 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.
The product is the generic of Celgene’s Revlimid. With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg.
[Read more: Dr. Reddy's intros generic Revlimid in Canada]
Revlimid is used to treat adult patients with multiple myeloma.
In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, a 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 United States 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 also is licensed to sell generic lenalidomide capsules in the United States without volume limitation beginning on Jan. 31, 2026.
[Read more: Dr. Reddy's unveils generic BiCNU]
“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,” said Marc Kikuchi, Dr. Reddy's CEO, North America generics. “We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”