INDIA – The United States Food and Drug Administration (USFDA) has granted approval to Sun Pharma’s generic medication indicated for several hematological malignancies in adults.
The license comes after Sun Pharma reached a settlement with Celgene Corporation in June 2021 to resolve the patent litigation regarding its generic lenalidomide capsules.
Celgene granted Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US, effective March 2022.
Celgene, which is now part of Bristol Myers Squibb, also agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the United States in a settlement.
Following the settlement, Sun Pharma has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.
Sun Pharma will manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US from January 31, 2026 in line with the terms of the settlement.
Lenalidomide is an immunomodulatory prescription, which is used to treat patients with multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma.
Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings.
The respective product approval of Sun Pharma’s generic lenalidomide capsules is based on Revlimid capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product.
Moreover, Sun Pharma’s generic lenalidomide capsules is a generic equivalent of Bristol Myers Squibb’s Revlimid (lenalidomide) capsules.
Revlimid had annual sales of US$2.58 billion for the 12-month period ending June 2022, according to IQVIA data.
In addition to the US FDA approval for generic medication, Sun Pharma recently entered into a landmark deal to acquire Concert for up to US$576 million in equity value.
“Specialty is expected to continue as a key growth driver for Sun Pharma. We are investing to scale up this business, especially in our core therapy areas. Proposed Concert acquisition is a step forward in this direction,” said Dilip Shanghvi, Managing Director of Sun Pharma.
With the acquisition of Concert, Sun Pharma seeks to build its global Dermatology and Ophthalmology franchise and aims to be a preferred development and commercial partner in these therapies worldwide.
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