On Tuesday, Indian-based pharmaceutical company Dr. Reddy’s Laboratories announced the final approval of its Abbreviated New Drug Application (ANDA) for generic lenalidomide capsules from the Food and Drug Administration (USFDA).
In a press release, the company said the FDA approved lenalidomide capsules in 2.5 mg and 20 mg strengths, giving tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths.
“With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg,” the company said.
Sold under the trade name Revlimid and others, lenalidomide is used to treat multiple myeloma, myelodysplastic syndromes, and a variety of other cancers.
The drug has also been used to successfully treat inflammatory disorders. Lenalidomide has been found to have three main activities – anti-tumor effect, inhibition of angiogenesis, and immunomodulation. In addition, it has a broad range of activities that can be used to treat hematologic and solid cancers.
In September, Dr. Reddy’s announced a settlement agreement of their litigation with New Jersey-based pharma company Celgene, the maker of brand Revlimid. Celgene is a Bristol Myers Squibb company.
Marc Kikuchi, CEO – North America Generics at Dr. Reddy’s Laboratories, said, “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. We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”
Celgene has also agreed to provide a license to Dr. Reddy’s so it can sell volume-limited amounts of generic lenalidomide in the U.S. market, probably from March 2022.
The company’s press release said, “Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning January 31, 2026.” The story was first published in The Economic Times.
