Sun Pharmaceutical Industries (Sun Pharma) along with one of its fully-owned subsidiaries has reached an agreement with Celgene, a fully-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation pertaining to generic Revlimid (lenalidomide).

The patent litigation is about the submission of an abbreviated new drug application (ANDA) for a generic version of lenalidomide capsules in the US.

Revlimid is indicated in the US for the treatment of multiple myeloma and myelodysplastic syndromes.

As per the terms of the settlement, Celgene will issue a license to Sun Pharma to its patents needed for manufacturing and selling, subject to approval from the US Food and Drug Administration (FDA) certain limited quantity of generic lenalidomide capsules in the US.

Sun Pharma will be able to do so from a confidential date that is sometime after March 2022. Apart from that, the license will enable the Indian pharma company to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US starting from 31 January 2026.

According to Sun Pharma, all Hatch-Waxman litigation it has with Celgene regarding the Revlimid patents will be dismissed, owing to the settlement. The settlement agreement is contingent on customary regulatory approvals.

Last month, another Indian pharma company – Natco Pharma had secured the final approval from the FDA of its ANDA for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative approval of the 2.5mg and 20mg.

  Bristol-Myers Squibb, Celgene, lenalidomide, Multiple myeloma, Myelodysplastic syndrome, myelodysplastic syndromes, REVLIMID, Sun Pharma, Sun Pharmaceutical Industries, USA