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Sun Pharma settles patent dispute with US Celgene Corporation
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SME Times News Bureau | 22 Jun, 2021
Pharma major Sun Pharmaceutical Industries Ltd. on Tuesday said it along
with one of its subsidiaries have reached an agreement with Celgene
Corporation (Celgene) to resolve a patent litigation.
In a
statement Sun Pharma said it along with its subsidiary has agreed with
Celgene Corporation-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.
As per the agreement, Celgene
will grant Sun Pharma a license to Celgene's patents required to
manufacture and sell (subject to USFDA approval) certain limited
quantity of generic lenalidomide capsules in the US sometime after March
2022.
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.
According to Sun
Pharma, as a result of the settlement between Sun Pharma and Celgene
under the US Hatch-Waxman Act, regarding the Revlimid patents, will be
dismissed.
Additional details regarding the settlement are
confidential. The agreement is subject to customary regulatory
approvals, Sun Pharma said.
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