FDA approves first Suboxone generics for opioid dependence

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FDA approves first Suboxone generics for opioid dependence

Genéricos/Novedades | Posted 13/07/2018 0 Post your comment

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.

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. This combination of medications is used as part of a complete treatment programme including prescription monitoring, counselling and psychosocial support.

FDA Commissioner Scott Gottlieb, said that ‘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’.

Opioid addiction is a growing problem in the US [1] and, according to Alok Sonig, Chief Executive Officer of Developed Markets at Dr Reddy’s, ‘this important product will help enable patients to prevail over this insidious disease’.

Dr Reddy’s would not, however, be able to launch its product just yet. UK-based addiction treatment manufacturer Indivior has appealed against a US court ruling that decided that Dr Reddy’s had not infringed patents on Suboxone patents [2]. Pending a hearing and decision on the injunction application, the court has issued a temporary restraining order against Dr Reddy’s with respect to further sales and commercialization of Buprenorphine and Naloxone sublingual film within the US.

References
1. GaBI Online - Generics and Biosimilars Initiative. Endo removes Opana ER opioid from the market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Generics/News/Endo-removes-Opana-ER-opioid-from-the-market
2. GaBI Online - Generics and Biosimilars Initiative. Indivior to appeal US ruling on opioid addiction patent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 13]. Available from: www.gabionline.net/Generics/News/Indivior-to-appeal-US-ruling-on-opioid-addiction-patent

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Source: Dr Reddy’s,Mylan