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Dr. Reddy's Laboratories Announces the Launch of Dimethyl Fumarate Delayed-Release Capsules in the U.S. Market

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Dr. Reddy's Laboratories has launched Dimethyl Fumarate Delayed-Release Capsules, a generic equivalent of Tecfidera®, approved by the U.S. FDA. The launch addresses a significant market, with U.S. sales of the Tecfidera® brand reaching approximately $3.8 billion for the twelve months ending June 2020, according to IQVIA Health. The new capsules are available in 120 mg and 240 mg strengths, offered in bottles of 14 and 60 capsules. This development expands Dr. Reddy's generics portfolio aimed at providing affordable medicines.

Positive
  • Launch of Dimethyl Fumarate Delayed-Release Capsules provides a new revenue stream.
  • The product targets a lucrative market, with Tecfidera® generating approximately $3.8 billion in sales.
Negative
  • None.

HYDERABAD, India & PRINCETON, N.J.--()--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr.Reddy’s”) today announced the launch of Dimethyl Fumarate Delayed-Release Capsules, a therapeutic equivalent generic version of Tecfidera® (dimethyl fumarate) Delayed-Release Capsules, approved by the U.S. Food and Drug Administration (USFDA).

The Tecfidera® brand and generic market had U.S. sales of approximately $3.8 billion MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Dimethyl Fumarate Delayed-Release Capsules are available in 120 mg and 240 mg capsules in bottle count sizes of 14 and 60 capsules, respectively.

Please see full prescribing information.
https://www.drreddys.com/pi/dimethyl-fumarate.pdf

Tecfidera® is a trademark of Biogen.

*IQVIA Retail and Non-Retail MAT June 2020

RDY-0820-312

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) 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, 2020. The company assumes no obligation to update any information contained herein.”

Contacts

INVESTOR RELATIONS
AMIT AGARWAL
amita@drreddys.com
(PH: +91-40-49002135)

MEDIA RELATIONS
APARNA TEKURI
aparnatekuri@drreddys.com
(PH: +91-40- 49002446)

FAQ

What new product did Dr. Reddy's launch on September 26, 2020?

Dr. Reddy's launched Dimethyl Fumarate Delayed-Release Capsules, a generic version of Tecfidera®.

What is the market size for Tecfidera® in the U.S.?

The Tecfidera® brand had U.S. sales of approximately $3.8 billion for the twelve months ending in June 2020.

What are the available strengths and packaging of Dimethyl Fumarate Capsules?

The capsules are available in 120 mg and 240 mg strengths, in bottle counts of 14 and 60 capsules.

Dr. Reddy's Laboratories Limited American Depositary Shares

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