Dr Reddy’s gets US FDA approval to launch Suboxone generic1 min read . Updated: 15 Jun 2018, 08:44 PM IST
The US FDA approval means Dr Reddy's will be able to launch in the US a generic version of Suboxone Film, which accounted for 80% of Indivior's revenue last year
Mumbai: Shares of Dr Reddy’s Laboratories Ltd, India’s second largest drug maker, soared over 3% in afternoon trade on the BSE, after the pharma firm said the US Food and Drug Administration (US FDA) had given it the go-ahead to launch generic versions a drug used to treat adults with opioid addiction. The original drug, Suboxone Sublingual Film, is manufactured by London-listed Indivior. Dr Reddy’s generics are called Buprenorphine and Naloxone Sublingual Film.
The approval means Dr Reddy’s will be able to launch a cheaper version of Suboxone Film in the US, which accounted for 80% of Indivior’s revenues last year.
On Friday, Dr Reddy’s shares rose 3.65%, Rs82.70, to Rs2,351.10 apiece on the BSE while the benchmark Sensex ended flat at 35,622.14 points.
“Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and Naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment program including prescription monitoring, counselling, and psychosocial support," the company said in a filing to the exchanges.
“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," explains Alok Sonig, chief executive officer, developed markets, Dr Reddy’s.
According to a report of the council of economic advisers, part of the executive office of the US President, in 2015 more than 33,000 Americans died of drug overdose involving opioids.
US FDA commissioner Scott Gottlieb said on Friday, “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access."
According to IMS Health, Suboxone registered US sales of approximately $1.86 billion for the 12 months to April 2018. Suboxone Film, a principal product of Indivor, is taken orally to help reduce dependence on opiods.
Dr Reddy’s had bought the new drug application for a generic rival treatment from Teva Pharmaceutical industries in June 2016 for $70 million.