Indivior rocked by loss of patent case

pharmafile | March 23, 2018 | News story | Medical Communications, Sales and Marketing Alvogen, biotech, drugs, indivior, opioid, pharma, pharmaceutical 

Indivior has been dealt a hammer blow after US District Court for the District of Delaware found in favour of Alvogen over claims of patent infringement.

The case relates to Indivior’s lead product, Suboxone Film, which is responsible for 80% of the company’s revenue. The court ruled that Alvogen did not infringe upon three patents held by Indivior with its generic version.

Due to the loss of the case, it could open up the potential for Alvogen to press ahead with an ‘at-risk’ launch of its rival product. This eventuality would significantly impact on sales of Suboxone, with Indivior commenting that it “believes that it could potentially result in a rapid and material loss of market share for Suboxone Film in the US, an effect that could occur within months of a successful launch of a generic film alternative into the US market.”

The loss of the case was enough to initially wipe 20% off the share price of the company, before they rebounded again to sit just 2.2% below the price prior to the release of the news.

The product itself is a strip that is placed in the mouth once-daily, which delivers a dose of buprenorphine and naloxone. The medicine is used to treat those suffering from opioid addiction, giving them lower doses of an opioid (buprenorphine) in order to help manage people away from their addiction to opioids, such as heroin or prescription painkillers.

Shaun Thaxter, CEO of Indivior, said: “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. 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.”

Sublocade is a new product from the company and is widely expected to become a blockbuster, however, sales are expected to begin slowly and the company will need sales of Suboxone Film to tide itself over until that time.

The loss of exclusivity would hit the company hard, but it has chosen not to update its financial guidance for the year looking ahead.

Ben Hargreaves

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