Dr. Reddy';s Laboratories announces the launch of Difluprednate Ophthalmic Emulsion 0.05% in the U.S. Market

Rhea-AI Summary

Dr. Reddy's Laboratories has launched a therapeutic generic version of Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following FDA approval. This product is aimed at enhancing the accessibility of ophthalmic treatments. The brand and generic had U.S. sales of approximately $40 million for the twelve months ending November 2022, according to IQVIA. Dr. Reddy's Difluprednate is available in 5 ml bottles, packaged in lots of 24. The company continues to emphasize its commitment to providing affordable healthcare solutions.

Positive

• Launch of a therapeutic generic equivalent to Durezol® enhances product portfolio.
• Potential market impact with U.S. sales for Durezol® reaching approximately $40 million annually.

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 Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05%, a therapeutic generic equivalent to Durezol® (Difluprednate Ophthalmic Emulsion 0.05%) in the U.S. market, following the approval by the U.S. Food and Drug Administration (USFDA).

The Durezol® brand and generic had U.S. sales of approximately $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA*.

Dr. Reddy’s Difluprednate Ophthalmic Emulsion 0.05% is available in 5 ml bottles in case packs of 24.

Please click here for full prescribing information: https://drreddys.com/pi/PI_Difluprednate-Opthalmic.pdf.

Durezol® is a trademark of Novartis AG.

RDY-0123-505

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. 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/20230127005193/en/

INVESTOR RELATIONS

RICHA PERIWAL

RICHAPERIWAL@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the significance of Dr. Reddy's launch of Difluprednate Ophthalmic Emulsion?

The launch represents Dr. Reddy's entry into the market for a product that had U.S. sales of approximately $40 million, potentially increasing the company's market share.

When did Dr. Reddy's receive FDA approval for Difluprednate?

Dr. Reddy's announced the FDA approval for Difluprednate Ophthalmic Emulsion recently in January 2023.

What are the available pack sizes for Difluprednate by Dr. Reddy's?

Dr. Reddy's Difluprednate is available in 5 ml bottles, packaged in case packs of 24.

How does the launch of Difluprednate affect Dr. Reddy's stock symbol RDY?

The launch could positively influence RDY's stock performance by potentially increasing revenue from this therapeutic product.