Celgene Corporation announced the settlement of litigation with Natco Pharma Ltd. of India, Natco's US partner Arrow International Limited, and Arrow's parent company, Watson Laboratories, Inc. (a wholly-owned subsidiary of Allergan plc) relating to patents for Revlimid (lenalidomide).
As part of the settlement, the parties will file Consent Judgments with the that enjoin 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 will permit entry of generic lenalidomide before the April 2027 expiration of Celgene's last-to-expire patent listed in the Orange Book for Revlimid. Celgene has agreed to provide Natco with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic lenalidomide in commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total lenalidomide capsules dispensed in the US in the final year of the volume-limited license under this agreement. Natco's ability to market lenalidomide in the US will be contingent on its obtaining approval of an Abbreviated New Drug Application.
"We believe strongly in our patent estate for Revlimid, and that this settlement appropriately recognizes the strength of our patents. This settlement provides clarity around the future of Revlimid, and we will continue to focus on developing our many important pipeline assets, which provide great potential promise to patients with unmet medical needs," said Bob Hugin, chairman and CEO of Celgene Corporation. "We remain confident in the strength of our patents, and will continue to vigorously defend them."
In the US, Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. 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 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. Revlimid is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.