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Dr. Reddy’s announces the re-launch of over-the-counter Famotidine Tablets USP, 10 mg and 20 mg, store-brand equivalent of Pepcid AC® in the U.S. Market

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Dr. Reddy’s Laboratories has re-launched OTC Famotidine Tablets USP, 10 mg and 20 mg, in the U.S. market after receiving USFDA approval. These tablets serve as generic equivalents of Pepcid AC®, helping to fill a therapy gap created by the withdrawal of Ranitidine. The Pepcid AC® brand generated approximately $211 million in U.S. sales in the twelve months ending August 2020. Available in various pack sizes, this move expands Dr. Reddy’s OTC Antacid portfolio, catering to customer needs and providing relief from heartburn and acid indigestion.

Positive
  • Re-launch of OTC Famotidine Tablets expands product portfolio.
  • Addresses therapy gap from Ranitidine withdrawal.
  • Potential market size of $211 million previously generated by Pepcid AC®.
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 re-launch of over-the-counter (OTC) Famotidine Tablets USP, 10 mg and 20 mg, the store-brand equivalents of Original Strength and Maximum Strength Pepcid AC®, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers that prevent and relieve heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.

"We are pleased to continue to expand our OTC Antacid portfolio for our customers and consumers,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “This launch will help us fulfil an important therapy gap created in Antacids market due to Ranitidine withdrawal.”

The Pepcid AC® brand and generic had U.S. sales of approximately $211 million for the most recent twelve months ending in August 2020 according to IRi*.

Dr. Reddy’s OTC Famotidine Tablets USP, 10 mg and 20 mg, are available in multiple pack sizes to allow consumers a variety of purchasing options.

Pepcid AC® is a registered trademark of Johnson & Johnson.

* IRi, Latest 52 weeks ending August 2020

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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 did Dr. Reddy’s announce regarding Famotidine tablets on October 20, 2020?

Dr. Reddy’s announced the re-launch of OTC Famotidine Tablets USP, 10 mg and 20 mg, in the U.S. market.

What is the significance of the Famotidine re-launch for Dr. Reddy’s?

The re-launch helps fill a therapy gap left by the withdrawal of Ranitidine and expands their OTC Antacid portfolio.

What were the U.S. sales figures for Pepcid AC® prior to the re-launch of Famotidine tablets?

Pepcid AC® had approximately $211 million in U.S. sales for the twelve months ending August 2020.

Who approved the re-launch of Famotidine Tablets by Dr. Reddy’s?

The re-launch was approved by the U.S. Food and Drug Administration (USFDA).

What are the strengths of the new Famotidine tablets being offered?

Dr. Reddy’s offers Famotidine Tablets USP in strengths of 10 mg and 20 mg.

Dr. Reddy's Laboratories Limited American Depositary Shares

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