Dr. Reddy's Laboratories announces the launch of Fluphenazine Hydrochloride Tablets, USP in the U.S. Market

Rhea-AI Summary

Dr. Reddy’s Laboratories has launched Fluphenazine Hydrochloride Tablets, USP, a generic version of Prolixin Tablets, approved by the U.S. FDA. Available in 1 mg, 2.5 mg, 5 mg, and 10 mg doses, these tablets are expected to cater to a market with U.S. sales of approximately $134 million for the brand and generic within the last year. The launch is part of Dr. Reddy’s commitment to providing affordable medicines. The drug carries a warning regarding increased mortality risk in elderly patients with dementia-related psychosis.

Positive

• Launch of Fluphenazine Hydrochloride Tablets targets a market with $134 million in U.S. sales, potentially increasing revenue.
• FDA approval signifies compliance with regulatory standards, enhancing credibility in the market.

Negative

• Warning about increased mortality in elderly patients with dementia-related psychosis could limit market acceptance.

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 Fluphenazine Hydrochloride Tablets, USP, a therapeutic equivalent generic version of Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, approved by the U.S. Food and Drug Administration (USFDA).

The Prolixin brand and generic had U.S. sales of approximately $134 million MAT for the most recent twelve months ending in December 2020 according to IQVIA Health*.

Dr. Reddy’s Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.

Please see the full prescribing information including boxed warning. https://www.drreddys.com/pi/fluphenazine_hcl_tabs_pi.pdf

WARNING   Increased Mortality in Elderly Patients with Dementia-Related Psychosis:   Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Fluphenazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

*IQVIA National Sales Perspective: Retail and Non-Retail MAT December 2020

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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, 2020. The company assumes no obligation to update any information contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210217006089/en/

FAQ

What is the significance of Dr. Reddy's launch of Fluphenazine Hydrochloride Tablets?

The launch allows Dr. Reddy's to penetrate a market with substantial sales, providing a competitive edge.

What are the available dosages of Fluphenazine Hydrochloride Tablets?

The tablets are available in 1 mg, 2.5 mg, 5 mg, and 10 mg dosages.

What sales figures did Prolixin Tablets generate before the launch?

Prolixin brand and generic had U.S. sales of approximately $134 million MAT for the year ending December 2020.

Are there any risks associated with Fluphenazine Hydrochloride Tablets?

Yes, there is a warning about increased mortality in elderly patients with dementia-related psychosis.