USA – Sun Pharmaceutical Industries today announced settlement of patent litigation for generic Revlimid (lenalidomide) in the US.
Lenalidomide, sold under the trade name Revlimid among others, is a medication used to treat multiple myeloma (MM) and myelodysplastic syndromes (MDS), cancer forms that fall under leukemia.
Multiple myeloma is a relatively uncommon cancer. In the United States, the lifetime risk of getting multiple myeloma is 1 in 132 (0.76%).
The American Cancer Society’s estimates for multiple myeloma in the United States for 2021 are, About 34,920 new cases will be diagnosed (19,320 in men and 15,600 in women).
In 2020, an estimated 19.3 million new cancer cases (18.1 million excluding nonmelanoma skin cancer) and almost 10.0 million cancer deaths (9.9 million excluding nonmelanoma skin cancer) occurred worldwide.
Sun Pharmaceutical Industries along with one of its wholly owned subsidiaries has announced that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US.
Pursuant to the terms of the settlement, Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, will grant Sun Pharmaceutical Industries, a license to Celgene Corporation’s patents.
The patent grants Sun Pharma the rights required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the United States beginning on a confidential date that is sometime after March 2022.
This is conditional on US Food and Drugs Authority approval of the drug.
In addition, the license will also allow Sun Pharmaceutical Industries to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning on 31 January 2026.
As a result of the settlement, all Hatch-Waxman litigation between Sun Pharmaceutical Industries and Celgene Corporation, regarding the Revlimid (lenalidomide capsules) patents, will be dismissed.
As per the exchange filing on the bourses, additional details regarding the settlement are confidential and the agreement is subject to customary regulatory approvals.
Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.
According to allied researchers, the global cancer therapeutics market size was valued at $98,900 million in 2018 and is estimated to reach at $180,193 million by 2026, registering a CAGR of 7.7% from 2019 to 2026.
Cancer therapeutics involves the use and administration of chemotherapy and oncology drugs to treat cancer.