Cipla settles patent litigation for Revlimid with Celgene, Arunesh Verma

By: |
December 11, 2020 8:29 PM

Cipla’s ability to market lenalidomide in the US will be contingent on its obtaining approval of an abbreviated new drug application (ANDA), the domestic firm said.

Cipla also added that the specific volume-limited licence date and percentages agreed upon with it are confidential.

Pharma major Cipla on Friday announced the settlement of its patent litigation with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for Revlimid (lenalidomide).

“As part of the settlement, the parties will file consent judgements with the US 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,” Cipla said in a filing to BSE.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a licence 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, it added.

“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 filing said.

Cipla also added that the specific volume-limited licence date and percentages agreed upon with it are confidential.

In addition, Celgene has agreed to provide Cipla with a licence 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, the filing said.

Cipla’s ability to market lenalidomide in the US will be contingent on its obtaining approval of an abbreviated new drug application (ANDA), the domestic firm 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,” Cipla North America CEO Arunesh Verma said.

Shares of Cipla closed at Rs 755.90 per scrip on BSE, down 0.92 per cent from the previous close.

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