• Natco to Acquire License to Sell Generic Lena­lido­mide in the U.S. Without Volume Limitation commencing in late Jan­u­ary­, 2026
• License Will Also Provide Natco With a Volume-Limited Entry Beginning in March, 2022 with Anticipated Mid-Single-Digit Percentage Of Capsules Sold In the First 12 Months, Anticipated to Increase Gradually Each Year

{{image}}Summit, NJ (Press Release) – Celgene Corpo­ra­tion (NASDAQ: CELG) today announced the settle­ment of lit­i­ga­tion with Natco Pharma Ltd. of India, Natco’s U.S. 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 United States 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 license to Celgene’s patents required to manu­fac­ture and sell an unlimited quantity of generic lena­lido­mide in the United States beginning on Jan­u­ary­ 31, 2026. In addi­tion, Natco will re­ceive a volume-limited license to sell generic lena­lido­mide in the United States 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 U.S. in the final year of the volume-limited license under this agree­ment. Natco’s ability to mar­ket lena­lido­mide in the U.S. 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.”

About Celgene

Celgene Corpo­ra­tion, headquartered in Summit, New Jersey, is an integrated global bio­pharma­ceu­tical com­pany engaged primarily in the discovery, devel­op­ment and com­mer­cial­iza­tion of inno­va­tive ther­a­pies for the treat­ment of cancer and inflammatory dis­eases through gene and protein reg­u­la­tion. For more in­­for­ma­tion, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn and YouTube.

About REVLIMID^®

In the U.S., 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 U.S. 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. Limitations of Use: REVLIMID^® is not in­di­cated and is not rec­om­mended for the treat­ment of chronic lym­pho­cytic leukemia (CLL) outside of con­trolled clin­i­cal trials.

Forward-Looking Statements

This press release con­tains for­ward-looking state­ments, which are generally state­ments that are not historical facts. Forward-looking state­ments can be identified by the words "expects," "antic­i­pates," "believes," "intends," "esti­mates," "plans," "will," “outlook” and similar ex­pres­sions. Forward-looking state­ments are based on man­agement’s current plans, esti­mates, assump­tions and pro­jec­tions, and speak only as of the date they are made. We under­take no obli­ga­tion to update any for­ward-looking state­ment in light of new in­­for­ma­tion or future events, except as other­wise required by law. Forward-looking state­ments in­volve­ in­her­ent risks and un­cer­tain­ties, most of which are dif­fi­cult to predict and are generally beyond our con­trol. Actual results or out­comes may differ ma­teri­ally from those implied by the for­ward-looking state­ments as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Se­cu­ri­ties and Ex­change Com­mis­sion.

Source: Celgene.