Full Press Release Details
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
Please find enclosed a Press Release on "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."
This is for your information.
For Dr. Reddy's Laboratories Limited
| /s/ K Randhir Singh | |
| K Randhir Singh | |
| Company Secretary & Compliance Officer |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, | AMIT AGARWAL | USHA IYER |
| Hyderabad - 500034. Telangana, India. | amita@drreddys.com | ushaiyer@drreddys.com |
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
Hyderabad, India and Princeton, NJ, USA.
September 7, 2022 - 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
and VENOUS and ARTERIAL THROMBOEMBOLISM
See full prescribing information for complete boxed warning.
EMBRYO-FETAL TOXICITY
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
Revlimid is a trademark
of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.
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 levels and frequency / severity of insured loss events, (ii) 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