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Indivior PLC tumbles after US patent setback

Last updated: 10:30 23 Mar 2018 GMT, First published: 08:13 23 Mar 2018 GMT

Suboxone
A hit on revenues could occur within months of a successful launch of a generic film alternative into the US market

Indivior PLC (LON:INDV), the pharma company spun out of Reckitt Benckiser, is to appeal against a ruling by the District Court of Delaware.

The court found that the pharmaceutical company Alvogen has not infringed on Indivior's patents with its generic version of the UK company's Suboxone, one of the best-selling treatments for heroin addiction.

Unless Indivior can get the ruling reversed, it would not be able to rely on three US patents to prevent Alvogen from marketing a generic film alternative to Suboxone in the US and might have increased difficulty in successfully defending its intellectual property against other drugs makers looking to produce copycat versions of Suboxone.

READ: Indivior files another lawsuit in latest bid to stop copycats of its best-selling addiction drug

At present, the US Food and Drug Administration (FDA) has not, to the best of Indivior's knowledge, granted authorisation to Alvogen to market a generic version of Suboxone film in the US.

“Any market launch would be on an 'at risk' basis, as the company would have a claim for damages against Alvogen if the company prevails on appeal,” Indivior said.

In addition, Indivior has asserted two new Orange-Book listed patents (the '454 and '221 patents) against Alvogen and certain other companies that have made abbreviated new drug applications (ANDA) to the FDA, claiming infringement of Indivior's patents.

The financial guidance for fiscal 2018 provided by Indivior on February 15, 2018, assumed no generic film launch in 2018. The company conceded that even the launch of an 'at risk' generic version of Suboxone film would likely result in a rapid and material loss of market share in the US, but has left financial guidance unchanged at present.

"We believe we have strong intellectual property for Suboxone Film. We will appeal this ruling and continue to vigorously defend our intellectual property, including asserting the two new Orange-Book listed patents that have been granted for Suboxone Film,” said Shaun Thaxter, the chief executive of Indivior.

“We remain confident in Indivior's long-term outlook and vision. With the successful launch of SUBLOCADE (buprenorphine extended-release injection for subcutaneous use) earlier this month, we have the first and only once-monthly buprenorphine depot injection delivery system. With this potentially transformational treatment, we expect to extend our market-leading position in the addiction disease space, and we remain confident in achieving at least US$1 billion in peak SUBLOCADE net revenue," Thaxter said.

Shares in Indivior were down 91.2p to 317.1p in early deals before recovering to around 359p.

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