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Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US Posted 18/01/2019

India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).

Late in 2018, Dr Reddy’s launched omeprazole delayed-release tablets 20 mg, an over-the-counter (OTC) generic of Prilosec OTC tablets 20 mg in the US. Omeprazole delayed-release tablets are proton pump inhibitors used for the treatment of heartburn which occurs two or more days per week in adults. The tablets are available in bottles sold in cartons of one, two or three bottles each, with each bottle containing one complete 14-day course of treatment.

Suboxone is a sublingual film product (applied under the tongue) used for the treatment of patients who are addicted to narcotic drugs such as morphine, oxycodine, fentanyl and buprenorphine. Dr Reddy’s generic Suboxone anti-narcotic addiction medication was approved by the US Food and Drug Administration in June 2018 [1], and it had been launched immediately after approval. However, Indivior filed patent lawsuits against Dr Reddy’s (as well as against Actavis, Par, Alvogen and Teva) relating to infringements of its patent, and a subsequent US District Court’s injunction halted Dr Reddy’s sales and commercialization activities [2].  Late last year, Dr Reddy’s received a favourable decision from the US Court of Appeals ruling of non-infringement and allowing its generic Suboxone into US markets.

These recent developments present significant financial opportunities for Dr Reddy’s. According to Information Resources, Incorporated (IRI) data, the market of Prilosec OTC combined with private-label omeprazole OTC products had US retail sales of approximately US$492 million for the 12 months ending in October 2018. In addition, the demand for anti-narcotic addiction drugs is very high in the US; Dr Reddy’s are aiming to capture a market of US$50­‒US$60 million for their generic Suboxone for the current financial year.

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Indivior to appeal US ruling on opioid addiction patent

Dr Reddy’s faces temporary sales ban on generic esomeprazole

References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first Suboxone generics for opioid dependence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: http://gabionline.net/Generics/News/FDA-approves-first-Suboxone-generics-for-opioid-dependence
2. GaBI Online - Generics and Biosimilars Initiative. Way cleared in US for Suboxone and Zytiga generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from: http://gabionline.net/Generics/General/Way-cleared-in-US-for-Suboxone-and-Zytiga-generics

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