PIMAVANSERIN TARTRATE generics — when can they launch?
PIMAVANSERIN TARTRATE (PIMAVANSERIN TARTRATE) · · 27 active US patents · 0 expired
Where PIMAVANSERIN TARTRATE sits in the generic timeline
All listed Orange Book patents for PIMAVANSERIN TARTRATE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Other — 12 patents
- Method of Use — 6 patents
- Composition of Matter — 6 patents
- Formulation — 3 patents
FDA U-codes carved out by PIMAVANSERIN TARTRATE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1844 | (no description) |
U-1974 | (no description) |
Sample patent estate
Showing 6 of 27 active US patents. View full estate on the PIMAVANSERIN TARTRATE drug page →
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This patent protects a method of using a selective serotonin 2A/2C receptor inverse agonist, such as pimavanserin tartrate, to treat neurodegenerative diseases.USPTO title: Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
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This patent protects a method of using a selective serotonin 2A/2C receptor inverse agonist, such as pimavanserin tartrate, to treat neurodegenerative diseases.USPTO title: Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
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This patent protects a method of using a selective serotonin 2A/2C receptor inverse agonist, such as pimavanserin tartrate, to treat neurodegenerative diseases.USPTO title: Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
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This patent protects methods for synthesizing Pimavanserin Tartrate, its hemi-tartrate salt, and various crystalline forms of the substance.USPTO title: N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-Nâ²-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
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This patent protects methods for synthesizing Pimavanserin Tartrate, its hemi-tartrate salt, and various crystalline forms of the substance.USPTO title: N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-Nâ²-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
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This patent protects methods for synthesizing Pimavanserin Tartrate, its hemi-tartrate salt, and various crystalline forms of the substance.USPTO title: N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-Nâ²-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
Sources
- FDA Orange Book — patents listed against PIMAVANSERIN TARTRATE (NDA filed 2016)
- PIMAVANSERIN TARTRATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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