Dr. Reddy's Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity
September 07 2022 - 1:28PM
Business Wire
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE:
RDY, NSEIFSC: DRREDDY, along with its subsidiaries together
referred to as “Dr. Reddy’s”) today announced the launch, in the
U.S. market, of Lenalidomide Capsules, a therapeutic equivalent
generic version of REVLIMID® (lenalidomide) Capsules approved by
U.S. Food and Drug Administration (USFDA). With this volume-limited
launch, Dr. Reddy’s is eligible for first-to-market, 180 days of
generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20
mg strengths.
“We are pleased with the first-to-market launch of two of our
six strengths of Lenalidomide Capsules with 180-day market
exclusivity,” says Marc Kikuchi, CEO, North America Generics, Dr.
Reddy’s Laboratories. “Bringing a more affordable generic version
to market creates greater patient access for this important
drug.”
As previously announced, Celgene agreed to provide Dr. Reddy’s
with a license to sell volume-limited amounts of generic
lenalidomide capsules in the U.S. in settlement of all outstanding
claims of its litigation. The agreed-upon percentages remain
confidential. As part of the settlement, 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 Lenalidomide Capsules are available in strengths of
2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well
as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size
of 21.
Please click here to see the full prescribing information, along
with boxed warning for Dr. Reddy’s Lenalidomide Capsules.
WARNING: EMBRYO-FETAL
TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL
THROMBOEMBOLISM
See full prescribing information for
complete boxed warning.
EMBRYO-FETAL
TOXICITY
- Lenalidomide, a thalidomide analogue, caused limb abnormalities
in a developmental monkey study similar to birth defects caused by
thalidomide in humans. If lenalidomide is used during pregnancy, it
may cause birth defects or embryo-fetal death.
- Pregnancy must be excluded before start of treatment. Prevent
pregnancy during treatment by the use of two reliable methods of
contraception.
Lenalidomide capsules are available only
through a restricted distribution program, called the Lenalidomide
REMS program.
HEMATOLOGIC
TOXICITY.
Lenalidomide can cause significant
neutropenia and thrombocytopenia.
VENOUS AND ARTERIAL
THROMBOEMBOLISM
- Significantly increased risk of deep vein thrombosis (DVT) and
pulmonary embolism (PE), as well as risk of myocardial infarction
and stroke in patients with multiple myeloma receiving lenalidomide
with dexamethasone. Anti-thrombotic prophylaxis is
recommended.
Revlimid® is a trademark of Celgene, a wholly-owned subsidiary
of Bristol Myers Squibb.
RDY-0822-441
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE:
500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated
pharmaceutical company, committed to providing affordable and
innovative medicines for healthier lives. Dr. Reddy’s offers a
portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are
gastrointestinal, cardiovascular, diabetology, oncology, pain
management and dermatology. Dr. Reddy’s operates in markets across
the globe. Our major markets include – USA, India, Russia & CIS
countries, and Europe. For more information, log on to:
www.drreddys.com
Disclaimer: This press release may include statements of future
expectations and other forward-looking statements that are based on
the management’s current views and assumptions and involve known or
unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those expressed or
implied in such statements. In addition to statements which are
forward-looking by reason of context, the words "may", "will",
"should", "expects", "plans", "intends", "anticipates", "believes",
"estimates", "predicts", "potential", or "continue" and similar
expressions identify forward-looking statements. Actual results,
performance or events may differ materially from those in such
statements due to without limitation, (i) general economic
conditions such as performance of financial markets, credit
defaults , currency exchange rates, interest rates, persistency
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mortality and morbidity levels and trends, (iii) changing levels of
competition and general competitive factors, (iv) changes in laws
and regulations and in the policies of central banks and/or
governments, (v) the impact of acquisitions or reorganization,
including related integration issues, and (vi) the susceptibility
of our industry and the markets addressed by our, and our
customers’, products and services to economic downturns as a result
of natural disasters, epidemics, pandemics or other widespread
illness, including coronavirus (or COVID-19), and (vii) other risks
and uncertainties identified in our public filings with the
Securities and Exchange Commission, including those listed under
the "Risk Factors" and "Forward-Looking Statements" sections of our
Annual Report on Form 20-F for the year ended March 31, 2022. The
company assumes no obligation to update any information contained
herein.
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INVESTOR RELATIONS AMIT AGARWAL amita@drreddys.com
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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