Celgene corporation is a subsidiary of Bristol Myers (BMS), an American multinational pharmaceutical company, headquartered in New York City. BMS is one of the world’s largest pharmaceutical companies. One of the main drugs manufactured by Celgene is an immunology drug against cancer, namely Lenalidomide sold under the trade name Revlimid, used to treat (MM) Multiple Myeloma and (MDS) Myelodysplastic Syndromes.
In December 2005, Celgene received approval from the FDA to market Revlimid.. It is part of a class of drugs called immunomodulatory drugs (IMiDs), which work against cancer cells partly by supporting the function of the immune system. Since then, many generics have filed ANDA (Abbreviated New Drug Application) for Revlimid drug including renowned pharmaceutical companies such as Dr Reddy Laboratories, Cipla Pharmaceutical Company, Natco Pharma and Lotus Pharmaceutical.
Celgene faced its first generic contender in 2010 when Natco Pharma, Arrow Pharmaceuticals and Watson Pharmaceutical Private Limited (collectively as NACTO ) filed an ANDA with FDA seeking approval to make a generic version of Celgene Corporations Lenalidomide Drug under the market name Revlimid, whereas Celgene Corporation proposed that Natco infringes its patents, which on the other hand initiated a Hatch-Waxman Lawsuit (known as Drug Price Competition and Patent Term Restoration Act).
Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad, which makes finished dosage formulations and active pharmaceutical ingredients (API). It is the market leader in branded oncology medicines in India, and among the country’s top three producers of hepatitis C drugs. A settlement agreement was agreed upon between Celgene Corporation and Natco Pharma which allowed Natco to initiate generic launch of the drug in March 2022. The agreement allowed Natco Pharma to begin manufacturing “mid-single-percentage” of Revlimid’s total volume, with this specified figure gradually increasing over time to one-third of Revlimid’s numbers.
Followed by Natco Pharma’s license to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after March 2022, Dr Reddy Laboratories was also granted the license to sell volume-limited amounts of Revlimid in U.S after March 2022.
In 2017, Celgene Corporation filed a patent infringement suit against Dr Reddy Laboratories. . The settlement agreement between Celgene and Dr Reddy Laboratory remains confidential. But in a settlement of all outstanding claims in this litigation, Celgene has agreed to provide Dr. Reddy’s Laboratories with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. Dr. Reddy’s was also granted a license to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026. The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on the settlement executed.
In an agreement between Celgene corporation and Alvogen in 2019, Celgene Corporation was able to settle disputes and reach a settlement with Alvogen over the sale and manufacturing of the anti-cancer drug. Alvogen is an American pharmaceutical company which has about 350 different medical and non-medical products, and it markets the products under the brand name pharmaceutical companies. Both Celgene and Alvogen reached a settlement and licensed Alvogen to sell generics up to single-digit percentages of Revlimid volumes sometime after March 2022. Alvogen had already launched a Revlimid generic earlier in some European countries. Global pharmaceutical company Alvogen reached the settlement of their litigation relating to patents for Revlimid (lenalidomide) with Celgene Corporation along with Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co. Ltd.
Celgene Corporation settled its patent dispute with Natco Pharma, Dr Reddy Laboratories and Alvogen respectively and all three companies can now roll out unlimited generics in the U.S. after January 31, 2026.
In March 2021 Cadila Healthcare settled its patent suit with Celgene Corporation over the anti-cancer drug Revlimid. Cadila Health (also known as Zydus Cadila) is an Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat, India primarily engaged in the manufacturing of generic drugs. In 2021 both Celgene and Cadila Healthcare will file a consent judgement which is a judgement specifying the settling disputes between the parties. This suit will be filed before the US Court which prohibits Zydas from marketing the generic drug before its patent expiration.
In June 2021, Celgene settled a patent infringement suit with Sun Pharmaceutical Industries Ltd, an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. This litigation was regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in US by Sun Pharma. Celgene agreed to grant a license to Sun Pharma, for a specific volume in exchange of royalty to manufacture and sell the drug, subject to the U.S. Food and Drug Administration approval. Celgene granted Sun Pharma a license to sell a certain limited quantity of generic lenalidomide capsules in the U.S. subject to USFDA approval, beginning on a confidential date, sometime after March 2022.
Therefore to conclude, Celgene corporation has settled its patent infringement suit against Sun Pharma in June 2021 and subsequently with companies like Natco Pharma, Dr Reddy Laboratories, Alvogen, Cadila Healthcare, Lotus Pharmaceuticals respectively. These Indian companies are leading pharma Medicare producers in India and are ranked amongst the fastest growing pharmaceutical companies in India.
By: ANUSHKA SEEMENDRA, ICFAI UNIVERSITY, DEHRADUN
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