Tris blocks Actavis’ ADHD generic
New Jersey-based Tris Pharma has won a ruling blocking Teva-owned Actavis from launching a generic version of attention deficit and hyperactivity disorder (ADHD) drug Quillivant XR (methylphenidate).
Quillivant XR is an extended-release liquid product which contains the same active ingredient as Novartis’ Ritalin, which has been in use since 1955.
Tris sued Actavis for patent infringement after the generic maker revealed plans to launch its own version of Quillivant XR in 2014.
In 2017, the US District Court for the District of Delaware ruled that the asserted Tris patents were invalid as obvious, in an early win for Actavis.
But this judgment was overturned in November 2018 by the US Court of Appeals for the Federal Circuit, which found that the Delaware court’s “obviousness decision lack[ed] the requisite fact-finding”.
The case was sent back to the district court for further proceedings and involved further briefings on the issues of validity and infringement.
In a judgment issued late last month, the Delaware court ruled that all of Tris’ asserted patent claims were valid and infringed by Actavis.
According to law firm Milbank, which represented Tris, the judgment will block Actavis from commercialising a generic version of Quillivant XR until the expiration of the patents in 2031.
“This is a huge win for Tris and provides for long exclusive life for a key portfolio product,” said Tris CEO Ketan Mehta.
Mehta added: “Validation of our IP permits Tris to continue investing in innovation to develop novel treatments that improve patients’ lives.”
Tris earlier this week announced a deal with Neuraxpharm, a drug company specialising in central nervous system (CNS) products, to commercialise Quillivant XR and related drug Quillichew ER in Europe.
“We are excited to add Tris’ differentiated ADHD medications to our CNS portfolio,” Jörg-Thomas Dierks, Neuraxpharm CEO, said.
“Both products offer a unique clinical profile, addressing the challenges experienced by many younger ADHD patients who have difficulty swallowing pills and finding an optimal dose,” Dierks added.
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