By: IPP Bureau
Last updated : September 09, 2022 9:24 am
Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S.
Dr. Reddy's Laboratories announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules approved by US Food and Drug Administration (USFDA). With this volume-limited launch, Dr. Reddy's is eligible for first-tomarket, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.
"We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories. "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 January 31, 2026.