Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg* in the U.S.

Rhea-AI Summary

Dr. Reddy's Laboratories announced the launch of Doxycycline Capsules, 40 mg in the U.S., a generic equivalent of ORACEA® approved by the USFDA. The capsules contain immediate-release and delayed-release pellets, each totaling 40 mg of anhydrous doxycycline. This launch is a significant development for Dr. Reddy's in the U.S. market.

Positive

• Expanding product portfolio with the launch of Doxycycline Capsules, 40 mg in the U.S.

• Approval by the USFDA for the therapeutic generic equivalent of ORACEA®.

• Inclusion of immediate-release and delayed-release pellets in the capsule formulation.

Negative

• None.

Insights

Pharmaceutical Market Analyst

The launch of Dr. Reddy's Doxycycline Capsules, a generic equivalent of ORACEA®, represents a strategic move to capture market share within the tetracycline-class antimicrobial market. While generics typically have lower margins, volume sales can be significant, especially in a market with established demand. This launch is likely fueled by the expiration of ORACEA®'s market exclusivity, opening the space for competitive pricing and accessibility. Considering the prevalence of conditions treated by doxycycline, such as acne and rosacea, the drug may well find a robust market, subject to pricing strategies and insurance coverage. For retail investors, this could translate into a steady revenue stream for Dr. Reddy's in the mid to long-term, assuming the company successfully navigates market penetration and manages production costs effectively. It's important to note that new entrants in generic markets can initiate price competition, potentially leading to decreased margins industry-wide.

Medical Research Analyst

Doxycycline is an antibiotic used to treat various infections and has a well-established efficacy profile. Dr. Reddy's version contains both immediate-release and delayed-release pellets, providing a pharmacokinetic profile that may be advantageous for patients requiring a consistent therapeutic level of antibiotic. The medical community may view this launch positively if the generic version proves to be as effective as the branded ORACEA®, while being more cost-effective. However, the generic drug's success will also depend on Dr. Reddy's ability to manage the supply chain and ensure consistent product availability. Given the widespread use of doxycycline, a generic alternative could benefit the healthcare system by potentially reducing overall treatment costs, provided quality and availability remain uncompromised.

HYDERABAD, India--(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 its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s Doxycycline Capsules, 40 mg*, are supplied in bottle counts of 30.

Please click here to see the full prescribing information - https://www.drreddys.com/pil/doxycycline-capsules.pdf.

*Each capsule contains: 26 mg immediate-release pellets and 14 mg delayed-release pellets equivalent to 40 mg of anhydrous doxycycline, USP.

ORACEA^® is a trademark of Galderma Holdings, S.A.

RDY-0524-642

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, 2023. The company assumes no obligation to update any information contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240503373906/en/

INVESTOR RELATIONS

RICHA PERIWAL

RICHAPERIWAL@drreddys.com

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy's Laboratories Ltd.

FAQ

What did Dr. Reddy's Laboratories announce?

Dr. Reddy's announced the launch of Doxycycline Capsules, 40 mg in the U.S., a generic equivalent of ORACEA® approved by the USFDA.

What is the composition of each Doxycycline Capsule?

Each capsule contains 26 mg immediate-release pellets and 14 mg delayed-release pellets equivalent to 40 mg of anhydrous doxycycline, USP.

What is the trademark for ORACEA®?

ORACEA® is a trademark of Galderma Holdings, S.A.

Where can the full prescribing information be found?

The full prescribing information can be found at https://www.drreddys.com/pil/doxycycline-capsules.pdf.