Dr. Reddy';s Laboratories Announces the Launch of Venlafaxine ER Tablets in the U.S. Market

Rhea-AI Summary

Dr. Reddy’s Laboratories Ltd. has launched Venlafaxine ER Tablets, which are therapeutically equivalent to Osmotica Pharmaceutical's product. The FDA approved these tablets in strengths of 150 mg and 225 mg, contributing to the U.S. market with sales around $51 million for the year ending October 2021. The new products come in bottle sizes of 30 and 90. The release includes important safety information regarding suicidality risks associated with antidepressants, emphasizing careful monitoring for patients.

Positive

• Launch of Venlafaxine ER Tablets expands product portfolio.
• FDA approval enhances credibility and market access.
• Projected U.S. market sales of approximately $51 million enhance revenue potential.

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 Venlafaxine ER Tablets which is therapeutically equivalent to Venlafaxine Extended-Release Tablets, 150 mg and 225 mg, of Osmotica Pharmaceutical US LLC approved by the U.S. Food and Drug Administration (USFDA).

The brand and generic had U.S. sales of approximately $51 million MAT for the most recent twelve months ending in October 2021 according to IQVIA Health*.

Dr. Reddy’s Venlafaxine ER Tablets are available in 150 mg and 225 mg strengths in bottle count sizes of 30 and 90.

See Important Safety Information below. Click here to see the full prescribing information including boxed warning: https://www.drreddys.com/pil/PIL-Venlafaxine-ER-Tabs-150-and-225-mg-(Appco-DrReddys).pdf.

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS   Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine extended-release tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine extended-release tablets are not approved for use in pediatric patients. [See Warnings and Precautions (5.1) and Patient Counseling Information (17.1)]

*IQVIA Retail and Non-Retail MAT October 2021.

RDY-1121-380

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 businesses, 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/20211209006185/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 significance of Dr. Reddy’s launch of Venlafaxine ER Tablets (NYSE: RDY)?

The launch signifies Dr. Reddy’s expansion in the antidepressant market, providing a therapeutically equivalent product to an existing FDA-approved medication.

What are the strengths and sizes of Venlafaxine ER Tablets offered by Dr. Reddy’s?

Dr. Reddy’s offers Venlafaxine ER Tablets in 150 mg and 225 mg strengths, with bottle sizes of 30 and 90.

How much did the Venlafaxine market generate for the year ending October 2021?

The U.S. Venlafaxine market generated approximately $51 million for the twelve months ending October 2021.

What safety warnings are associated with Venlafaxine ER Tablets (RDY)?

The FDA warns of increased risks of suicidal thoughts and behaviors in children, adolescents, and young adults, necessitating close monitoring.