Dr Reddy’s labs announces final approval of ANDA for Lenalidomide capsules

Insight Online News

Hyderabad, Oct 19 : Dr. Reddy’s Laboratories Limited on Tuesday announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules.

The Lenalidomide capsules will be 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, Hyderabad-based pharmaceutical giant is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

In September last year, 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 (NYSE: BMY), relating to patents for the branded drug, the pharma company said in a release here.

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, Dr Reddy’s Laboratories CEO ( North American Generics) Marc Kikuchi said.

“We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients”, he added.

UNIINDIA

Leave a Reply

Your email address will not be published. Required fields are marked *