Dr. Reddy';s Laboratories Announces the Launch of Fesoterodine Fumarate Extended-Release Tablets in the U.S. Market

Rhea-AI Summary

Dr. Reddy’s Laboratories has launched Fesoterodine Fumarate Extended-Release Tablets in the U.S., a generic equivalent to Toviaz®, approved by the U.S. FDA. The brand Toviaz® recorded U.S. sales of approximately $211 million for the year ending May 2022. The new product is available in 4 mg and 8 mg tablets, in bottles of 30. This therapeutic launch marks Dr. Reddy’s commitment to providing affordable medications in key international markets.

Positive

• Launch of Fesoterodine Fumarate Extended-Release Tablets expands product portfolio.
• Approval from U.S. FDA enhances credibility and market access.
• Access to a market with Toviaz® sales at approximately $211 million indicates potential revenue.

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”) announces the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA).

The Toviaz® brand had U.S. sales of approximately $211 million MAT for the most recent twelve months ending in May 2022 according to IQVIA.

Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.

Please click here to see the full prescribing information: https://www.drreddys.com/pil/pi_fesoterodine-fumarate-er-oral-tablet-extended-release-24-hour.pdf.

Toviaz is a trademark of Pfizer Inc.

RDY-0622-424

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/20220708005386/en/

INVESTOR RELATIONS

AMIT AGARWAL

amita@drreddys.com



MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What did Dr. Reddy's announce in their recent press release?

Dr. Reddy's announced the launch of Fesoterodine Fumarate Extended-Release Tablets in the U.S., a generic equivalent to Toviaz®.

When was Dr. Reddy's Fesoterodine Fumarate approved?

It was approved by the U.S. FDA before its launch.

What are the strengths available for Dr. Reddy's Fesoterodine Fumarate Extended-Release Tablets?

The tablets are available in 4 mg and 8 mg strengths.

What were the U.S. sales figures for the Toviaz® brand?

The Toviaz® brand had U.S. sales of approximately $211 million for the twelve months ending in May 2022.

How many tablets are in each bottle of Dr. Reddy's Fesoterodine Fumarate?

Each bottle contains 30 tablets.