Acadia Pharmaceuticals gained a legal milestone for its lead Parkinson’s disease (PD) drug, Nuplazid (pimavanserin), after the US District Court for the District of Delaware passed judgment in favor of in favor of Acadia’s ‘721 formulation patent.
The favorable ruling protects the two marketed forms of Nuplazid. The 10 mg tablet will be protected until 2037 and the 34 mg capsule will be protected until 2038. This comes hours after the court confirmed the validity of the ‘740 composition of matter patent that safeguards Acadia’s lead drug into 2030.
Approved by the US Food and Drug Administration (FDA) in 2016, Nuplazid’s active ingredient is pimavanserin, a non-dopaminergic anti-psychotic serotonin inverse agonist and antagonist designed to selectively target 5-HT2A receptors, thereby preventing hallucinations and delusions associated with PD psychosis. GlobalData expects Nuplazid sales to reach $1.2bn by 2029.
The positive announcement also resulted in Acadia’s stock value jumping by 24.5%.
In legal action that dates back to 2020, Acadia initially moved to keep five generic formulations of Nuplazid out of the market in the case called the Pimavanserin I Cases. As detailed in a 3 November SEC filing, the company filed complaints against Aurobindo Pharma, Teva Pharmaceuticals, Hetero Labs, MSN Laboratories, and Zydus Pharmaceuticals in July 2020 on alleged patent infringement.
The San Diego-based biopharmaceutical company resurrected the infringement case by filing additional complaints against Aurobindo, MSN, and Zydus in October 2022 in what is called the Pimavanserin II Cases.
As per the filing, the San Diego-based biopharmaceutical company settled its cases against Hetero and Zydus by establishing agreements allowing the companies to launch generic pimavanserin products at later dates. Hetero will launch its product on 27 February 2038 and Zydus agreed to launch its 10 mg product on 23 September 2036 and its 34 mg product also on 27 February 2038.
Aurobindo and MSN are the only remaining defendants, with MSN being the only company active in both pimavanserin cases.
As a result of the 13 December ruling, the claims construction ‘Markman’ hearing, which was originally scheduled for 19 December 2023, has been cancelled. The 2 December 2024 trial will proceed as scheduled.
GlobalData is the parent company of Pharmaceutical Technology.
