Sun Pharma bags USFDA approval for Generic Lenalidomide Capsules

10 Feb 2023 , 02:15 PM

Sun Pharmaceutical Industries Limited announced that one of its wholly-owned subsidiaries has bagged the final USFDA approval for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 25mg, 15mg, 5mg, 10mg, and tentative approval for 2.5mg, 20mg.

The company stated that the respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg, and 2.5mg, 20mg as a reference product.

Sun Pharma reached an agreement with Celgene Corporation (Celgene) in June 2021 to settle the patent litigation involving Sun Pharma’s generic lenalidomide capsules.

In accordance with the agreement reached, Celgene has generously bestowed upon Sun Pharma the authorization to utilize Celgene’s patents for the production and distribution of a limited quantity of generic lenalidomide capsules in the US, starting from a date after March 2022.

Furthermore, the license opens up the opportunity for Sun Pharma to unlimitedly produce and sell generic lenalidomide capsules in the US market beginning January 31, 2026.

At around 2.04 PM, Sun Pharma was trading at Rs1,005.30 per piece, down by 0.15% against the previous close of Rs1,006.80 on NSE.

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