Nuplazid (Pimavanserin): The 2030-2038 Generic Opportunity Window

Acadia Pharmaceuticals' Nuplazid (pimavanserin, FDA NDA 207318 / 210793) generated $609.4M in 2024 and over $680M in 2025 as the exclusive therapy for Parkinson's disease psychosis. Core composition-of-matter patent US 7,601,740 expires April 29, 2030 (October 29, 2030 with pediatric exclusivity), upheld by the Federal Circuit against MSN Laboratories. Secondary formulation patents (US 10,449,185 and US 10,646,480) extend Orange Book protection through August 27, 2038 (February 27, 2039 with pediatric exclusivity). Commercial status: 100% Brand-only in the United States today with zero generic pimavanserin sold. Major Indian generic challengers, including MSN Laboratories and Aurobindo Pharma, hold tentative ANDA approvals positioning for generic entry. Scope note: Unresolved litigation claims and confidential settlement terms are excluded from this analysis.