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Please find enclosed a Press Release on "Dr.
Reddy's Laboratories announces approval for Lenalidomide Capsules from the U.S. Food and Drug Administration (USFDA)"
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | AMIT AGARWAL amita@drreddys.com | USHA IYER ushaiyer@drreddys.com |
Laboratories announces approval for Lenalidomide
Capsules from the U.S. Food and Drug Administration (USFDA)
Hyderabad, India and Princeton, NJ, USA.
October 19, 2021 - 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 final approval of its Abbreviated
New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15
mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the U.S. Food
and Drug Administration (USFDA). With this approval, Dr. Reddy's is eligible for 180 days of generic drug exclusivity for
Lenalidomide Capsules, 2.5 mg and 20 mg.
In September 2020, Dr. Reddy's announced
a settlement agreement of their litigation with Celgene, the maker of REVLIMID (lenalidomide) Capsules and a wholly-owned
subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for the branded drug.
In settlement of all outstanding claims in
the litigation, Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide
capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. 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.
"We are pleased with the Agency's
approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity," says Marc Kikuchi,
CEO, North America Generics, Dr. Reddy's Laboratories. "We look forward to bringing a more affordable generic version
of this drug to market for the benefit of patients."
Please refer to Lenalidomide Capsules 2.5 mg and 20 mg Package
Insert for Black Box warning and important safety information. Please click here for full prescribing information: https://www.drreddys.com/pi/final-25mg-20mg.pdf
Revlimid is a trademark
of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.
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. Through its three businesses - Pharmaceutical
Services & Active Ingredients, Global Generics and Proprietary Products - 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, 2021. The company assumes no obligation to update any information