Dr Reddy's launches genericSuboxone in US market

Dr Reddy's Laboratories Ltd today announced it is launching Buprenorphine and Naloxone Sublingual Film, of multiple strengths following the final approval from the US Food and Drug Administration (FDA).

According to a press release issued by the city-based drug maker, the product in strengths of 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg is a therapeutic equivalent generic version of Suboxone (buprenorphine and naloxone) sublingual film, in the United States market.

The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) programme, it said.

Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction.

Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids.

"With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients," Chief Executive Officer, Developed Markets, Alok Sonig, said.

"We are excited to be launching this important product that will help enable patients to prevail over this insidious disease," he added.

This approval is an important milestone for the company and a testament to its commitment to bring affordable generic medicines to market for patients, Sonig said.

"Our company will continue to look for opportunitiesto acquire and manufacture assets that accelerate access to innovative and affordable medicines for patients," he further said.

The Suboxone brand had US sales of approximately USD 1.86 billion MAT for the most recent twelve months ending in April 2018 according to IMS Health, the release said.