Amid a wave of patent litigation over Johnson & Johnson's portfolio of schizophrenia treatments, the company has successfully batted away a copycat challenge from Viatris.
Viatris’ proposed generics of J&J’s long-lasting Invega Trinza would "induce infringement" of the so-called '693 patent, New Jersey District Judge Evelyn Padin wrote in court documents filed this week. Viatris’ attempts to show the patent is invalid have fallen flat, Padin continued.
J&J first sued Viatris—at the time still Mylan—back in September 2020 after the company sought approval for generic versions of Invega Trinza’s 546-mg dose.
J&J launched two subsequent lawsuits over Viatris’ attempts at approval for separate doses. The litigation was ultimately consolidated into a single case in January 2022. This week, J&J prevailed in that case.
J&J’s '693 patent is set to expire April 5, 2036, according to the FDA's Orange Book listing of patent and exclusivity data.
J&J has been battling to keep Invega generics at bay on multiple fronts. Much of the company’s defense revolves around Invega Sustenna, a shorter-acting version of the schizophrenia med.
Invega’s multiple presentations form a blockbuster franchise in J&J’s neuroscience roster. Altogether, the drugs brought home about $4.1 billion in 2022.
Injectable Invega Trinza lasts for three months. J&J figures longer-acting injectables reduce the risk of patients forgetting to take a daily pill.
Still, J&J faces competition in the long-acting schizophrenia injectable market, where Otsuka and its partner Lundbeck sell the once-monthly injection for schizophrenia and bipolar disorder known as Abilify Maintena.
Late last month, meanwhile, the FDA signed off on Abilify Asimtufii, an extended-release, injectable suspension given every two months.
Elsewhere on the long-acting schizophrenia treatment scene, Teva and MedinCell recently scored an FDA nod for Uzedy (risperidone) after a turbulent regulatory process that included a complete response letter. The drug can be administered at one- or two-month intervals.