Dr. Reddy';s Laboratories Announces the Launch of Valsartan Tablets, USP in the U.S. Market

Rhea-AI Summary

Dr. Reddy's Laboratories has launched Valsartan Tablets, a generic version of Diovan® approved by the U.S. FDA. The brand had U.S. sales of approximately $150 million for the twelve months ending October 2021 according to IQVIA Health. The Valsartan Tablets are available in various dosages, including 40 mg, 80 mg, 160 mg, and 320 mg. A warning regarding fetal toxicity is included, advising discontinuation if pregnancy is detected. This launch positions Dr. Reddy’s strategically within the generic pharmaceutical market.

Positive

• Launch of Valsartan Tablets provides a new revenue stream.
• Generic version targets a market with annual sales of approximately $150 million.

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 of Valsartan Tablets, USP, a therapeutic equivalent generic version of Diovan® (valsartan) Tablets approved by the U.S. Food and Drug Administration (USFDA).

The Diovan® brand and generic market had U.S. sales of approximately $150 million MAT for the most recent twelve months ending in October 2021 according to IQVIA Health*.

Dr. Reddy’s Valsartan Tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90.

Please click here for full prescribing information including boxed warning: https://www.drreddys.com/pil/150084612-Valsartan-Tablets_Outsert-v_10.pdf

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue Valsartan as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)

Diovan^® is a trademark owned or licensed by Novartis Corporation.

*IQVIA Retail and Non-Retail MAT October 2021

RDY-1021-377

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. Through its businesses, 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 contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211209005397/en/

INVESTOR RELATIONS

AMIT AGARWAL

AMITA@DRREDDYS.COM

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What are Valsartan Tablets launched by Dr. Reddy's?

Valsartan Tablets are a generic version of Diovan® approved by the U.S. FDA.

What is the market size for Valsartan in the U.S.?

The U.S. market for Diovan® and its generics was approximately $150 million for the year ending October 2021.

What dosages are available for Dr. Reddy's Valsartan Tablets?

Valsartan Tablets are available in 40 mg, 80 mg, 160 mg, and 320 mg dosages.

What is the significance of the Valsartan launch for RDY?

The launch provides Dr. Reddy's access to a significant market opportunity, enhancing its product portfolio.