On Friday, Sun Pharmaceutical Industries announced that its subsidiary has been granted approval by the US Food and Drug Administration (FDA) to market a generic drug for the treatment of multiple myeloma.
Sun Pharmaceutical Industries has announced that its subsidiary has received the final approval from the United States Food and Drug Administration (USFDA) for the generic lenalidomide capsules. According to a statement released by the company, the approval covers multiple strengths of the medication.
This marks an important milestone for the company and its efforts to bring affordable and accessible treatments to patients in need. The approval of the generic lenalidomide capsules is expected to help address a significant unmet need for patients suffering from multiple myeloma.
In June 2021, Sun Pharma reached a settlement agreement with Celgene Corporation to resolve the patent dispute related to its generic lenalidomide capsules.
As part of the settlement, Celgene provided Sun Pharma with a license to the necessary patents to produce and sell a limited quantity of generic lenalidomide capsules in the United States, starting from a date after March 2022.
Additionally, the settlement agreement included provisions that permit Sun Pharma to further expand its operations in the United States. The license granted by Celgene allows Sun Pharma to not only manufacture but also sell an unlimited quantity of generic lenalidomide capsules in the country starting from January 31, 2026. This represents a significant development for the company, as it opens up new opportunities for growth and revenue generation in the US market.
The license provides Sun Pharma with the necessary legal authorization to bring these critical treatments to patients in need, and is an important step towards fulfilling the company’s mission of improving access to high-quality, affordable healthcare.
