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Sun Pharma enters patent litigation settlement with Celgene for launch of generic Revlimid

As per the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022.

June 22, 2021 / 09:24 AM IST
Revlimid is a blockbuster blood cancer drug with sales of $12.1 billion for BMS in 2020.

Revlimid is a blockbuster blood cancer drug with sales of $12.1 billion for BMS in 2020.

 
 
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Sun Pharma, India's largest drug-maker, has reached an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb (BMS), 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.

Revlimid is a blockbuster blood cancer drug with sales of $12.1 billion for BMS in 2020.

As per the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. This will be subject to USFDA approval.

In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

"As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed.

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Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals.

BMS has settled with other Indian generic drug makers such as Natco Pharma, Dr Reddy's. The first generic is expected to enter the market in 2022.
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Jun 22, 2021 09:24 am

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