Cipla Settles Patent Litigation over REVLIMID Capsules with Celgene, Bristol Myers in US

As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents in suit, except as provided for in the settlement, as described below.;

Published On 2020-12-12 11:06 GMT | Update On 2020-12-12 11:06 GMT

Mumbai: Cipla Limited has recently announced the settlement of its litigation with Celgene Corporation, and a wholly-owned subsidiary of Bristol Myers Squibb relating to patents for REVLIMID (lenalidomide).

As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after March 2022. For each consecutive twelve-month period (or part thereof) following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed-upon percentages. The specific volume-limited license date and percentages agreed-upon with Cipla are confidential.

In addition, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026. Cipla's ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

Mr. Arunesh Verma, CEO, Cipla North America, said, "This is an important step forward for us and is in line with our pursuit of improving access to high-quality life-saving treatments."

Read also: COVID antibody test in 10 mins: Cipla launches Covi-G for COVID-19 rapid antibody detection

In the U.S., REVLIMID (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID as a single agent is also indicated as maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

Read also: Cipla says demand for Covid antiviral drug remdesivir rising sharply in India

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Cipla Settles Patent Litigation over REVLIMID Capsules with Celgene, Bristol Myers in US

As part of the settlement, the Parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents in suit, except as provided for in the settlement, as described below.;

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