Indivior to appeal court verdict over Suboxone Film patents
Indivior, which specialises in addiction treatment drugs, intends to launch an appeal against a US District Court for the District of Delaware verdict that could lead to rival companies selling a generic version of its Suboxone Film, a drug to treat opioid addiction.
On Friday, September 1, the ruling found the company’s US patent numbers 8,017,150 (“Polyethylene oxide-based films”); 8,603,514(“Uniform films”); and 8,900,497 (“Process for making a film”) valid, but that Dr. Reddy’s, Watson’s (Actavis) and Par’s proposed generic products do not infringe them.
The US Food and Drug Administration (FDA) has not yet approved the Abbreviated New Drug Applications.
According to Indivior, a UK-based company, it does not know how much financial damage a generic alternative to Suboxone Film would do to the company in the long term. However, data shows that Suboxone Film accounted for 80% of Indivior’s US revenue for the year ending December 2016.
Shaun Thaxter, CEO of Indivior, said: “Today’s news is disappointing to Indivior, given the belief that the company has in its intellectual property for Suboxone Film. 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 that has created unrivalled relationships with healthcare professionals, medical societies, regulators, payors and policy makers to expand access to opioid dependence treatment.”
Thaxter went on to say that progress is being made to make buprenorphine monthly depot (RBP-6000), which has the potential to transform the treatment of opioid use disorder.
