FDA Approves Generic of Revlimid

The FDA has approved Dr. Reddy’s abbreviated new drug application for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and given a tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths. Lenalidomide is a therapeutic equivalent generic version of Celgene’s Revlimid, which is an oral cancer drug that is used for the treatment of multiple myeloma.

With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg.

In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug. 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 date sometime after March 2022.

As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the United States without volume restrictions beginning on Jan. 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,” Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories, said in a statement.

Dr. Reddy’s has also launched a generic version of carmustine for injection, a therapeutic equivalent generic version of Emcur Pharmaceuticlal’s BiCNU, a cancer therapeutic used to treat patients with brain tumors, multiple myeloma, Hodgkin disease, and non-Hodgkin lymphoma.