Dr. Reddy's Laboratories announces the launch of Febuxostat Tablets in the U.S. Market

Rhea-AI Summary

Dr. Reddy’s Laboratories Ltd. has launched Febuxostat Tablets, a generic version of Uloric, approved by the USFDA. The Uloric brand and its generic had US sales of approximately $108 million for the 12 months ending October 2020, according to IQVIA Health. Febuxostat Tablets are available in two strengths: 40 mg and 80 mg, in bottles of 30 tablets. Warning: Gout patients with cardiovascular disease may face higher rates of cardiovascular death when treated with Febuxostat compared to allopurinol. Prescribers should consider risks and benefits before use.

Positive

• Launch of Febuxostat Tablets, expanding Dr. Reddy's product portfolio.
• Generics market potential from Uloric's approximately $108 million US sales.

Negative

• Higher cardiovascular death rates associated with Febuxostat in gout patients with cardiovascular disease.

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 Febuxostat Tablets, a therapeutic equivalent generic version of Uloric (Febuxostat) Tablets approved by the U.S. Food and Drug Administration (USFDA).

The Uloric brand and generic had U.S. sales of approximately $108 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health*.

Dr. Reddy’s Febuxostat Tablets are available in 40 mg and 80 mg strengths in bottle count sizes of 30 tablets.

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

WARNING: CARDIOVASCULAR DEATH   Gout patients with established cardiovascular (CV) disease treated with Febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)].   Consider the risks and benefits of Febuxostat when deciding to prescribe or continue patients on Febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1)].

Uloric is a trademark of TEIJIN KABUSHIKI KAISHA (TEIJIN LIMITED)
*IQVIA Retail and Non-Retail MAT October 2020.
RDY-0121-323

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 gene

FAQ

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

Dr. Reddy's launch of Febuxostat Tablets represents a therapeutic equivalent to Uloric, expanding its generic offerings and tapping into a market that generated approximately $108 million in the US.

What are the strengths and packaging of Febuxostat Tablets launched by Dr. Reddy's?

Febuxostat Tablets are available in strengths of 40 mg and 80 mg, packaged in bottles of 30 tablets.

What warnings are associated with Febuxostat Tablets?

There is a warning regarding increased cardiovascular death rates in gout patients with cardiovascular disease compared to allopurinol.

How much did Uloric and its generic generate in sales?

According to IQVIA Health, Uloric and its generic had US sales of approximately $108 million over the last twelve months ending October 2020.

What should prescribers consider before prescribing Febuxostat?

Prescribers should weigh the cardiovascular risks against the benefits of Febuxostat, especially in patients with established cardiovascular disease.