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Dr. Reddy’s Announces the Re-Launch of Over-the-Counter Naproxen Sodium Tablets USP, 220 mg, Store-Brand Equivalent of Aleve® in the U.S. Market

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Dr. Reddy’s Laboratories Ltd. has announced the re-launch of its OTC Naproxen Sodium Tablets USP, 220 mg in the U.S., approved by the FDA. This product is a store-brand equivalent of Aleve® and serves as a pain reliever and fever reducer. CEO Marc Kikuchi highlighted its significance in the company's Pain/Analgesics portfolio, emphasizing the robust supply chain for consistent product availability. Naproxen Sodium had U.S. retail sales of around $316 million as of July 2021, and the tablets will come in various pack sizes for consumer convenience.

Positive
  • Re-launch of OTC Naproxen Sodium Tablets enhances the Pain/Analgesics portfolio.
  • FDA approval signifies compliance with regulatory standards.
  • Naproxen Sodium had U.S. retail sales of approximately $316 million as of July 2021.
Negative
  • None.

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 re-launch of over-the-counter (OTC) Naproxen Sodium Tablets USP, 220 mg, the store-brand equivalent of Aleve®, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

“The re-launch of Dr. Reddy’s Naproxen Sodium Tablets, 220 mg (OTC), is an important addition to our Pain/Analgesics portfolio of OTC products,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “This launch represents our continued endeavor to leverage our strong capabilities and vertically integrated supply chain on key APIs like naproxen to ensure a consistent and reliable supply of finished products for our customers and patients.”

Dr. Reddy’s OTC Naproxen Sodium Tablets USP, 220 mg is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) for use as a pain reliever and fever reducer. It temporarily relieves minor aches and pains due to: minor pain of arthritis, muscular aches, backache, menstrual cramps, headache, toothache, and the common cold; it is also used to temporarily reduce fever.

Naproxen Sodium Tablets USP, 220 mg, had U.S. retail sales of approximately $316 million as of July 2021 according to IRI*.

Dr. Reddy’s Naproxen Sodium Tablets USP, 220 mg, will be available in multiple-pack sizes to allow consumers a variety of purchasing options.

Aleve® is a trademark of Bayer HealthCare LLC.

*IRI POS TOTAL US – MULO Period ending July 11, 2021

RDY-0821-OTC

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 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 contained herein.”

FAQ

What is the significance of Dr. Reddy's re-launch of Naproxen Sodium Tablets USP, 220 mg?

The re-launch adds to Dr. Reddy's Pain/Analgesics portfolio, indicating growth in the OTC market.

When was the re-launch of OTC Naproxen Sodium Tablets announced?

Dr. Reddy's announced the re-launch on August 3, 2021.

What are the retail sales figures for Naproxen Sodium Tablets in the U.S. market?

Naproxen Sodium had U.S. retail sales of approximately $316 million as of July 2021.

What does the FDA approval mean for Dr. Reddy's Naproxen Sodium Tablets?

FDA approval ensures that the product meets safety and efficacy standards for consumer use.

What types of pain does Naproxen Sodium Tablets relieve?

Naproxen Sodium Tablets relieve minor aches due to arthritis, muscular aches, backache, menstrual cramps, headache, toothache, and the common cold.

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