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NUPLAZID

NDA

PIMAVANSERIN TARTRATE | N207318 | ACADIA PHARMACEUTICALS INC

2 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Expiring < 1yr (1)Active (4)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

Today

Oct. 29, 2030

Aug. 24, 2026

Dec. 3, 2028

Sep. 23, 2037

Sep. 23, 2037

M-14

Oct. 27, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
ACADIA Pharmaceuticals Inc. v. Zydus Lifesciences Limited et al 1:2025cv00187 5 patentsANDA 214502pimavanserin tartrate	D. Del.	2025-02-14	Active	—
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 1:2020cv01021 5 patentsANDA 214493, 214502pimavanserin	D. Del.	2020-07-30	Terminated 2023-04-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Zydus Pharmaceuticals (USA), Inc FDA-2024-P-3881 · 7 docket documents Zydus Pharmaceuticals (USA), Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA determine that Pimavanserin Tablets, 34 mg is suitable for submission in an Abbreviated New Drug Application, with th	Suitability	2024-08-14	Granted	Zydus Pharmaceuticals (USA), Inc
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-2514 · 4 docket documents Zydus Pharmaceuticals (USA) Inc. filed this petition on May 22, 2024, requesting that the FDA determine whether NUPLAZID (pimavanserin) tablets, 17 mg (NDA N207318), held by Acadia Pharmaceuticals Inc., was withdrawn from commercial sale for reasons of safety or effectiveness or for commercial reaso	505(q)	2024-05-23	Granted	Zydus Pharmaceuticals (USA) Inc.
Suitability Petition from Zydus Pharmaceuticals (USA) Inc FDA-2024-P-0435 · 4 docket documents Zydus Pharmaceuticals (USA) Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that Pimavanserin Tablets 34 mg is suitable for submission in an Abbreviated New Drug Application, with ACADIA PHARMACEUTICALS INC'	Suitability	2024-01-23	Denied	Zydus Pharmaceuticals (USA) Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

25 trials from ClinicalTrials.gov — 1 recruiting, 18 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis NCT04373317	Phase 4	Recruiting	VA Office of Research and Development	358	2022-10-24 → 2027-08-24
Expanded Access of Pimavanserin for Patients With PD Psychosis NCT02762591	—	APPROVED_FOR_MARKETING	ACADIA Pharmaceuticals Inc.	—	—
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients NCT01518309	Phase 2	Completed	ACADIA Pharmaceuticals Inc.	39	2004-11-17 → 2013-05-02
Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis NCT04292223	Phase 4	Completed	ACADIA Pharmaceuticals Inc.	29	2020-02-10 → 2022-04-26
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis NCT00477672	Phase 3	Completed	ACADIA Pharmaceuticals Inc.	298	2007-06 → 2009-07
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis NCT00550238	Phase 3	Completed	ACADIA Pharmaceuticals Inc.	459	2007-07 → 2018-05-30
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)NCT03018340	Phase 2	Completed	ACADIA Pharmaceuticals Inc.	207	2016-12 → 2018-10
Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease NCT03623321	Phase 3	Completed	ACADIA Pharmaceuticals Inc.	595	2018-07-17 → 2023-05-05
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease NCT03118947	Phase 2	Completed	ACADIA Pharmaceuticals Inc.	79	2017-02-23 → 2019-02-25
Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia (ENHANCE-1)NCT02970292	Phase 3	Completed	ACADIA Pharmaceuticals Inc.	396	2016-10-26 → 2019-06-25

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$3805.78

Highest Price

$5037.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
63090-0100-30NUPLAZID 10MG TAB	$5037.66	FSS	Acadia Pharmaceuticals	09/30/2028
63090-0100-30NUPLAZID 10MG TAB	$3805.78	Big4	Acadia Pharmaceuticals	09/30/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Nuplazid (2024)

Total Spending

$657.8M

Total Claims

143,328

Beneficiaries

17,122

Avg Cost/Unit

$165.57

Spending Trend

$311.9M(2019)→$416.0M(2020)→$470.9M(2021)→$528.9M(2022)→$595.7M(2023)→$657.8M(2024)

YoY Change:+2.3%

5yr CAGR:+8.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs1 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDPIMAVANSERIN TARTRATE

DMF 332922018

ZAKLADY FARMACEUTYCZNE POLPHARMA SAPIMAVANSERIN TARTRATE

DMF 333852018

DASAMI LAB PRIVATE LTDPIMAVANSERIN TARTRATE

DMF 343542020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPIMAVANSERIN TARTRATE

DMF 344152019

ZYDUS LIFESCIENCES LTDPIMAVANSERIN TARTRATE

DMF 350292020

JIANGSU TASLY DIYI PHARMACEUTICAL CO LTDPIMAVANSERIN TARTRATE

DMF 374302022

LIVZON NEW NORTH RIVER PHARMACEUTICAL CO LTDInactivePIMAVANSERIN TARTRATE (NON-STERILE, BULK FORM)

DMF 342892019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
May 1, 2026	SUPPL -16	View Letter (PDF)
Feb 7, 2025	SUPPL -14	View Letter (PDF)
Sep 18, 2023	SUPPL -12	View Letter (PDF)
Nov 25, 2020	SUPPL -10	View Letter (PDF)
Oct 1, 2019	SUPPL -9	View Letter (PDF)
May 13, 2019	SUPPL -7	View Letter (PDF)
Mar 7, 2019	SUPPL -6	View Letter (PDF)
Jul 6, 2018	SUPPL -3	View Letter (PDF)
Jun 14, 2018	SUPPL -5	View Letter (PDF)
Mar 15, 2018	SUPPL -4	View Letter (PDF)
Mar 15, 2018	SUPPL -2	View Letter (PDF)
Oct 19, 2017	SUPPL -1	View Letter (PDF)
May 2, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

3 patents2 exclusivities▴

TABLET;ORAL | Approved: Apr 29, 2016

Patents (3) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7601740	Apr 29, 2030PED: Oct 29, 2030	PED	Yes	Yes	—	—
7659285	Aug 24, 2026	—	—	—		—
7732615	Jun 3, 2028PED: Dec 3, 2028	PED	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
M-14	Apr 27, 2029	Active
PED	Oct 27, 2029	Active

#002 — EQ 10MG BASE

RLD

5 patents2 exclusivities▾

TABLET;ORAL | Approved: Jun 28, 2018