Indivior to appeal US ruling on opioid addiction patent

Generics/News | Posted 22/09/2017 post-comment0 Post your comment

UK-based addiction treatment manufacturer Indivior Plc have announced plans to appeal against a US court, which ruled that Indian generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) had not infringed patents on their opioid addiction treatment Suboxone.

88 MD002468

The patent dispute relates to Indivior’s major product, Suboxone Film (buprenorphine/naloxone), which is used to treat opioid addiction – a growing problem in the US [1]. In 2016, Suboxone accounted for 80% of Indivior’s total revenues and held a 61% market share in the US.

The company announced their intentions to appeal against the US District Court of Delaware on 1 September 2017. The Court ruled that generics maker Dr Reddy's had not infringed Indivior’s patents, which could allow them to market a rival to Suboxone Film. 

The US Food and Drug Administration (FDA) has so far not granted marketing authorization (tentative of final) to any generic version of Suboxone Film. However, if they grant approval to Dr Reddy’s, they could market a generic alternative in the US. 

Indivior are therefore calling for the ruling to be reversed. The company said the precise financial impact of generics alternatives could not be quantified, but that they could result in ‘rapid and material loss of market share’ for Suboxone.

They suggested that generics substitution could lead to a loss of 80% market share within months, which would clearly have a significant impact on the company’s revenues, profitability and cash flow.

CEO Shaun Thaxter described his disappointment with the news, ‘We will appeal the ruling and defend our intellectual property. We remain confident in Indivior’s long-term outlook and vision. Our confidence is based on our market leading position in the addiction disease space forged over the past 20 years ...’

Indivior says they have prepared contingency plans based on various possibilities and discussed a new treatment for opioid addiction, ‘Our focus and dedication continue to drive our innovative pipeline, particularly RBP-6000, which we expect will be a potentially transformational new option for the treatment of opioid use disorder. As always, our unwavering focus is on addressing the unmet needs of opioid dependent patients,’ Mr Thaxter added.

Back in June 2017, Indivior won further patent battles over Suboxone Film, against global generics firm Actavis and Endo subsidiary Par Pharmaceutical. The Court denied efforts by the companies to reopen the judgement, finding that their proposed generics infringed Indivior’s patents and preventing them from manufacturing and marketing generic alternatives in the US.

Indivior also produces treatments for cocaine addiction and alcohol dependence and claims to have the largest pipeline of addiction drugs in the world.

Related articles
FDA approves generic opiate-dependency drugs

1. GaBI Online - Generics and Biosimilars Initiative. Endo removes Opana ER opioid from the market []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 September 22]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

Source: Indivior

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010