Celgene settles Revlimid patent litigation
![](/46/pdcnewsitem/03/84/88/Celgene.png)
Natco to acquire licence to sell generic Lenalidomide in the US without volume limitation commencing in late January, 2026.
Celgene Corp. has 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 US District Court for the District of New Jersey that enjoin Natco 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 licence to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the US beginning on 31 January 2026. In addition, Natco will receive a volume-limited licence to sell generic lenalidomide in the US commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the US 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."
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance