Dr Reddy's gets USFDA nod to launch generic Suboxone, opts for 'at risk' launch

Viswanath Pilla
Moneycontrol News

Drug maker Dr Reddy’s on Friday said it has received final nod from USFDA to launch much awaited generic version of Suboxone sublingual film used in treatment of drug addiction.

Suboxone is a combination of Buprenorphine and Naloxone is marketed by British drug maker Reckitt Benckiser’s spun-off Indivior in US.

Dr Reddy’s got approval for all dosage forms 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg.

The Suboxone brand had U.S. sales of around USD 1.86 billion for the 12 months ended April 2018, according to IQVIA.

Shares of Dr Reddy’s rose 2.72 percent and were trading at Rs 2330.00 on BSE at 9.51 am, while the benchmark Sensex dropped 0.05 percent to 35,581.92 points.

At risk launch

Dr Reddy’s said it’s launching generic Suboxone at risk  – implying that the company is launching the product even as certain patent granted to the innovator is valid until 2023.  Indivior has sued Dr Reddy’s for infringement of its patents and litigation is still on.

Analysts say Dr Reddy’s is confident after recent court verdict going against Indivior, and delayed assertion of new patents, and two of the three patents being just an extension of old patents.

Dr Reddy’s also faces the risk of Indivior getting an injunction. In the worst case scenario if Dr Reddy’s loses patent litigation, it may have to forfeit sales made on the drug.

Dr Reddy’s bought Suboxone Film’s abbreviated new drug application (ANDA) from Teva Pharmaceuticals for USD 70 million in June 2016 with seven generic filers.

Mylan too got an approval from USFDA to launch generic Suboxone. It’s not immediately known whether Mylan will launch it immediately or wait till 2023. Mylan had a out of court settlement with Indivior on Suboxone.

Alvogen, Endo, Par Pharmaceuticals and Actavis are also in the race for US FDA approval, some of them have settled patent infringement cases with Indivior to launch an authorised generic.

“It’s a big approval for the company. We expect the drug contribute about USD 50 million in FY19 and USD 70 million in FY20 to Dr Reddy’s sales,” Amey Chalke, pharma analyst at HDFC Securities to Moneycontrol.

“Dr Reddy’s may not be manufacturing the product on its own, and relies on procurement from a third party, so the margins may not be huge, in addition to 3-4 player competition,” Chalke said.

Credit Suisse, estimates a successful launch of Suboxone’s generic could account for more than 10 percent of Dr Reddy’s profit in the ongoing financial year through March 2019.

Doctors prescribe Suboxone to help those struggling with opioid abuse to stop their illicit drug use and slowly taper off those drugs entirely. While buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids.

The drug became a major weapon in the fight against opioid abuse in US, but the cost however remained major barrier for access. It is estimated that there are 3 million Americans are Suboxone treatment.

The low-cost generic entry is expected to significantly expand number of people getting the opioid de-addiction treatment.

The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.

In a statement released earlier today by the USFDA, Commissioner Scott Gottlieb, MD, explained, “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.”

“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.

“Our company will continue to look for opportunities to acquire and manufacture assets that accelerate access to innovative and affordable medicines for patients,” Sonig said.

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