Dr. Reddy’s nods the FDA to generic Revlimid. Enjoy 180 days of exclusivity, Health News, ET Health World

Doctor Reddies Laboratories Ltd. announced on Tuesday the final approval of its shortened new drug application (ANDA). Lenalidomide capsule, From the US Food and Drug Administration (USFDA).

According to a press release issued by a Hyderabad-based pharmaceutical company, the FDA has approved 2.5 mg and 20 mg strength lenalidomide capsules and tentatively approved 5 mg, 10 mg, 15 mg, and 25 mg strengths. .. Lenalidomide is used to treat various types of cancer. 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. Reddies announced a settlement agreement with Celgene. Revrimid (Lenalidomide) A wholly owned subsidiary of Bristol Myers Squibb related to capsule and branded drug patents.

“We are pleased that lenalidomide capsules 2.5 mg and 20 mg have been approved by the authorities and gained 180 days of market exclusivity. To bring a more affordable generic version of this drug to the market for the benefit of our patients. “I’m looking forward to it,” said Kikuchi, CEO of Mark North America Generic, said Dr. Reddy’s Laboratories.

In the settlement of all outstanding claims in the proceedings, Celgene licensed Doctor Reddies to sell a limited quantity of generic lenalidomide capsules in the United States from a confidential date after March 2022, subject to regulatory approval. Agreed to provide.

The agreed percentage remains secret. As part of the settlement, Dr. The release states that Reddy’s is also allowed to sell generic lenalidomide capsules in the United States in unlimited quantities after January 31, 2026.

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