Dr. Reddy';s Laboratories Announces the Launch of Ephedrine Sulfate Injection USP, 50 mg/mL, Single-Dose Vial in the U.S. Market

Rhea-AI Summary

Dr. Reddy’s Laboratories has launched Ephedrine Sulfate Injection USP, a generic equivalent to Akovaz®, approved by the U.S. FDA. The U.S. market for this product generated approximately $67.5 million in sales over the last twelve months, ending August 2021. The injection is packaged in a 1 mL fill within a 2 mL single-dose vial, delivering 50 mg of ephedrine sulfate per mL. This launch aligns with Dr. Reddy’s commitment to providing affordable medications and addresses a significant market need.

Positive

• Launch of Ephedrine Sulfate Injection USP could capture a share of the $67.5 million U.S. market.
• Generic equivalent enables cost-effective treatment options for healthcare providers and patients.
• Approval by U.S. FDA enhances the company's reputation and market capabilities.

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 Ephedrine Sulfate Injection USP, 50 mg/mL, a therapeutic equivalent generic version of Akovaz® (ephedrine sulfate injection) Injection, 50 mg/mL approved by the U.S. Food and Drug Administration (USFDA).

The Akovaz® brand and generic market had U.S. sales of approximately $67.5 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Dr. Reddy’s Ephedrine Sulfate Injection USP, 50 mg/mL is a clear, colorless, sterile solution for intravenous injection and supplied as a 1 mL fill in a 2 mL clear glass single-dose vial with purple flip-off cap. Each mL contains 50 mg of ephedrine sulfate USP, equivalent to 38 mg ephedrine base.

Please click here for full prescribing information: https://www.drreddys.com/pi/Ephedrine-Sulfate-Inj-Leaflet-150085475.pdf

Akovaz® is a trademark of EXELA STERILE MEDICINES LLC

*IQVIA Retail and Non-Retail MAT August 2021

RDY-1021-376

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211029005287/en/

INVESTOR RELATIONS

AMIT AGARWAL

AMITA@DRREDDYS.COM

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the recent product launched by Dr. Reddy's Laboratories?

Dr. Reddy's Laboratories launched Ephedrine Sulfate Injection USP, a generic version of Akovaz®.

How much did the U.S. market for Akovaz generate recently?

The U.S. market for Akovaz generated approximately $67.5 million in sales over the last twelve months ending August 2021.

What is the significance of the U.S. FDA approval for Dr. Reddy's new product?

The U.S. FDA approval allows Dr. Reddy's to market Ephedrine Sulfate Injection, potentially increasing market share and revenue.

What form does the Ephedrine Sulfate Injection come in?

The Ephedrine Sulfate Injection is supplied as a 1 mL fill in a 2 mL clear glass single-dose vial.

What therapeutic area does Ephedrine Sulfate Injection target?

Ephedrine Sulfate Injection is used in therapeutic settings requiring ephedrine sulfate.