Proactive Investors - Run By Investors For Investors

Indivior on the back foot as Federal court rejects Suboxone appeal

The decision clears the way for generic rivals in the US
US court
Indivior is bracing for a severe loss of market share

Indivior PLC (LON:INDV) has suffered a major setback in attempts to defend its best-selling opioid addiction drug Suboxone from generic competition.

A US Federal Court of Appeal (CAFC) rejected Indivior’s request for another hearing on whether its patents were infringed by a low-cost alternative developed by Dr Reddy.

READ: Indivior sells rights related to opioid addiction treatment drug in China

A district court in Delaware had previously given the all-clear to the generic version.

The decision by the CAFC effectively ratifies that and clears the way for Dr Reddy to sell its rival in the US.

Indivior has applied for an emergency injunction to stop the Federal Court’s mandate, which comes into force on February 11.

Without that, Indivior expects both Dr Reddy and Alvogen, another generic rival, would start to market their products on that date.

Alvogen had agreed to wait until the CAFC decision on Dr Reddy.

Shaun Thaxter, Indivior’s chief executive, said he was disappointed by the CAFC’s decision.

"While we ultimately believe in the strength of our patent portfolio, we acknowledge that the company faces major disruption in the immediate future from a potential material and rapid loss of market share by our Suboxone film product to generic buprenorphine/naloxone sublingual film competition.”

Indivior will press ahead with appeals against the Delaware patent ruling and also in New Jersey against Dr Reddy and Alvogen but the former Reckitt Benckiser subsidiary has already set out contingency plans to deal with a loss of market share for Suboxone.

Measures include staff cuts, cash conservation and the launch of its own generic alternative.

View full INDV profile View Profile

Indivior Timeline

Related Articles

Sativa
April 02 2019
Geremy Thomas, founder and chief executive of Sativa, said the company has made significant progress since it started trading on NEX.
Social media use
Thu
Social first has allowed sites like UNILAD to amass a huge audience with very little capital injection, but what is social first publishing and how is it changing the nature of content and advertising?
PT exercises
December 19 2018
The Californian company is a bet on an industry that is in need of transformation

© Proactive Investors 2019

Proactive Investors Limited, trading as “Proactiveinvestors United Kingdom”, is Authorised and regulated by the Financial Conduct Authority.
Registered in England with Company Registration number 05639690. Group VAT registration number 872070825 FCA Registration number 559082. You can contact us here.

Market Indices, Commodities and Regulatory News Headlines copyright © Morningstar. Data delayed 15 minutes unless otherwise indicated. Terms of use