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USFDA approves Sun Pharma's generic medication

Sun Pharma received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement.

Sun Pharma posts 16.5% rise in Q3 net profit, declares dividend of Rs 8.50/share
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Sun Pharma posts 16.5% rise in Q3 net profit, declares dividend of Rs 8.50/share

Sun Pharma received final approval from the US Food and Drug Administration (USFDA) for the generic lenalidomide capsules in multiple strengths, Sun Pharma said in a statement.

In June 2021, Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding its generic lenalidomide capsules.

Under the terms of this settlement, Celgene granted Sun Pharma a license to patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US, beginning sometime after March 2022.

In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

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