Alvogen licensed to sell volume-limited amounts of generic
lenalidomide in the U.S. beginning on a confidential date after the
March 2022 date Celgene previously granted to Natco
Alvogen also licensed to sell generic lenalidomide in the U.S.
without volume limitation beginning on January 31, 2026
The earliest licensed entry of any generic lenalidomide in the U.S.
continues to be March 2022, based on settlements reached
SUMMIT, N.J.–(BUSINESS WIRE)–Celgene Corporation (NASDAQ:CELG) and Lotus Pharmaceutical Co., Ltd. and
Alvogen Pine Brook, LLC (collectively, Alvogen) today announced the
settlement of their litigation 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 Alvogen 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 has
agreed to provide Alvogen with a license to Celgene’s patents required
to manufacture and sell certain volume-limited amounts of generic
lenalidomide in the United States beginning on a confidential date that
is some time after the March 2022 volume-limited license date that
Celgene previously provided to Natco. For each consecutive twelve-month
period (or part thereof) following the volume-limited entry date until
January 31, 2026, the volume of generic lenalidomide sold by Alvogen
cannot exceed certain agreed-upon percentages. Although the agreed-upon
percentages are confidential, they increase gradually each period to no
more than a single-digit percentage in the final volume-limited period.
In addition, Celgene has agreed to provide Alvogen with a license 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.
Alvogen’s ability to market lenalidomide in the U.S. will be contingent
on its obtaining approval of an Abbreviated New Drug Application.
ABOUT CELGENE
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical 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 the Company’s
website at www.celgene.com.
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About REVLIMID®
In the U.S., REVLIMID® (lenalidomide) in combination with
dexamethasone is indicated for the treatment of patients with multiple
myeloma. REVLIMID® as a single agent is also indicated as a
maintenance therapy in patients with multiple myeloma following
autologous hematopoietic stem cell transplant. 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 Statement
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 U.S. Securities and
Exchange Commission, including factors related to the proposed
transaction between Bristol-Myers Squibb and Celgene, such as, but not
limited to, the risks that: management’s time and attention is diverted
on transaction related issues; disruption from the transaction makes it
more difficult to maintain business, contractual and operational
relationships; pending legal proceedings or any future litigation
instituted against Bristol-Myers Squibb, Celgene or the combined company
could delay or prevent the proposed transaction; and Bristol-Myers
Squibb, Celgene or the combined company is unable to retain key
personnel.
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Contacts
Celgene Corporation
Investors:
908-673-9628
ir@celgene.com
Media:
908-673-2275
media@celgene.com