Dr Reddy's Laboratories launches generic of Naproxen, Esomeprazole Magnesium Delayed-Release Tablets

Hyderabad  Dr Reddy's Laboratories Ltd. has announced the market launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, a therapeutic equivalent generic version of Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets approved by the U.S. Food and Drug Administration (USFDA).

"This launch is a testament to our core strengths in areas of research and development and intellectual property," says Marc Kikuchi, Chief Executive Officer, North America Generics. "We are excited to be a part of forming the first generic market for Vimovo® Tablets and to provide an affordable treatment alternative for patients."

The Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets brand had U.S. sales of approximately $414 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health*.

Dr Reddy's Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of 60. 

In its release the pharma major pointed out to some of the Warnings- Risk of serious cardiovascular and gastrointestinal events with the medication. These include

Cardiovascular Thrombotic Events

 Non-Steroidal Anti-inflammatory Drugs (NSAIDs), a component of naproxen and esomeprazole magnesium delayed-release tablets, cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

 Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

 NSAIDs, a component of naproxen and esomeprazole magnesium delayed-release tablets cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Read also: USFDA seeks voluntary action at Dr Reddy's Duvvada facility