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

Rhea-AI Summary

Dr. Reddy’s Laboratories has launched Lenalidomide Capsules, a generic version of REVLIMID®, in the U.S. Approved by the USFDA, this launch grants the company 180-day exclusivity for 2.5 mg and 20 mg strengths. The launch supports greater patient access and follows a settlement with Celgene, allowing Dr. Reddy’s to market limited amounts of the drug until January 31, 2026, when the volume limitation will be lifted. The capsules are available in various strengths, catering to diverse patient needs.

Positive

• Launch of Lenalidomide Capsules provides 180-day market exclusivity.
• Increased patient access to a more affordable generic version of an important drug.
• Settlement with Celgene allows for future unlimited sales starting January 31, 2026.

Negative

• None.

HYDERABAD, India & PRINCETON, N.J.--(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 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 contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220907006110/en/

INVESTOR RELATIONS

AMIT AGARWAL amita@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the significance of Dr. Reddy's launch of Lenalidomide Capsules (RDY)?

The launch of Lenalidomide Capsules marks Dr. Reddy’s entry into the U.S. market with a generic version of REVLIMID®, providing 180-day exclusivity and enhancing patient access to the medication.

When can Dr. Reddy's sell Lenalidomide Capsules without volume limitation?

Dr. Reddy’s is licensed to sell Lenalidomide Capsules in the U.S. without volume limitation starting January 31, 2026.

What strengths of Lenalidomide Capsules has Dr. Reddy's launched?

Dr. Reddy’s Lenalidomide Capsules are available in strengths of 2.5 mg and 20 mg, among others, catering to a variety of patient needs.

What is the expected market impact of Dr. Reddy's Lenalidomide Capsules launch?

The launch is expected to significantly increase patient access to lenalidomide, potentially enhancing revenue for Dr. Reddy's in the competitive U.S. generic market.

How does the settlement with Celgene affect Dr. Reddy's sales of Lenalidomide?

The settlement allows Dr. Reddy's to market a limited amount of Lenalidomide Capsules and to sell without restrictions beginning January 31, 2026.