Celgene controversies
Controversies tied to this brand in public sources. A listing is not a finding of fault.
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2021
Celgene sues Biocon Pharma over drug patents
Lawsuit filed
Celgene Corporation filed a complaint against Biocon Pharma in the District of New Jersey, alleging that Biocon's potential generic drug would infringe Celgene patents. Celgene sought relief including an injunction and a delay to the generic drug's approval effective date; the article reports allegations, not a court determination.
Source excerpt
On Friday, Celgene Corporation filed a complaint in the District of New Jersey. The case was filed against Biocon Pharma Inc.
Celgene alleged that the information submitted to the FDA on its face shows intent to infringe upon the patents held by Celgene and seeks redress.
2021
Zydus reaches U.S. patent litigation settlement concerning generic Revlimid
Settlement
Cadila Healthcare and its subsidiary Zydus Pharmaceuticals (USA), together referred to as Zydus Cadila, announced an agreement with Celgene concerning patents for Revlimid. Under the settlement, the parties will file consent judgments enjoining Zydus Cadila from marketing generic lenalidomide before the patents expire, except as provided in the settlement.
Source excerpt
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 Zydus Cadila from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement.
Cadila Healthcare Limited and its subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus Cadila) has announced that they have reached an agreement with Celgene Corporation (Celgene), a wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) relating to patents for REVLIMID® (lenalidomide).
2020
Dr. Reddy’s and Celgene settle Revlimid patent litigation
Settlement
Dr. Reddy’s announced a settlement of its litigation with Celgene over patents for Revlimid capsules. Under the settlement, Celgene agreed to license Dr. Reddy’s to sell volume-limited generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022, subject to regulatory approval, and without volume limitation beginning January 31, 2026.
Source excerpt
In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Dr. Reddy's 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 is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.
Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries (together referred to as "Dr. Reddy's"), today announced the settlement of their litigation with Celgene, a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for REVLIMID® (lenalidomide) Capsules.
2020
Cipla and Celgene settle Revlimid patent litigation
Settlement
Cipla announced a settlement of its patent litigation with Celgene concerning Revlimid. The settlement provides for consent judgments enjoining Cipla from marketing generic lenalidomide before the relevant patents expire, subject to settlement terms, and licenses for certain volume-limited US sales after a confidential date following March 2022 and unlimited sales no earlier than January 31, 2026. Cipla's ability to market the drug is contingent on obtaining ANDA approval.
Source excerpt
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).
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.
“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.
2018
FDA criticism over access to samples
The FDA listed Celgene among companies reported to have refused potential generic manufacturers access to samples needed for development and testing of competing products.
2017
False Claims Act settlement involving Revlimid and Thalomid
Celgene agreed to resolve government allegations that it caused false or fraudulent claims to be submitted for certain uses of Revlimid and Thalomid that were not reimbursable by Medicare or state Medicaid programs. Contemporary disclosures described a total resolution amount that included fees and expenses.
2009
Thalomid sample-access and antitrust dispute
Generic-drug companies challenged Celgene’s refusal to provide Thalomid samples for bioequivalence testing. Related litigation alleged that the restricted distribution system was used to impede generic competition; the principal case settled before trial.
Revlimid pricing criticism
Celgene and, later, Bristol Myers Squibb faced public criticism over repeated increases in Revlimid’s price. Specific price comparisons vary by source and time period; no financial figure is included here because the supplied material does not provide a verifiable source URL for the stated amounts.