Caplyta (Lumateperone): The 2029-2040 Generic Opportunity Window
Intra-Cellular Therapies' oral atypical antipsychotic and antidepressant blockbuster Caplyta generated $680.5M in 2024 (+47% YoY). Core substance and crystalline polymorph patents (US 8,648,077 and US 8,598,119) expire in December 2029, while secondary Orange Book method-of-use and formulation patents extend through December 2040. January 2025 Hatch-Waxman Paragraph IV settlement with Sandoz establishes generic entry on July 1, 2040, while litigation remains pending against Indian generic filers Zydus, Aurobindo, Alkem, and Hetero. Market is 100% brand-only in the US today.
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