NUPLAZID Drug Patent Profile

Which patents cover Nuplazid, and what generic alternatives are available?

Nuplazid is a drug marketed by Acadia Pharms Inc and is included in two NDAs. There are ten patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-eight patent family members in twenty-two countries.

The generic ingredient in NUPLAZID is pimavanserin tartrate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pimavanserin tartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nuplazid

Nuplazid was eligible for patent challenges on April 29, 2020.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NUPLAZID

International Patents:	88
US Patents:	10
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	143
Drug Prices:	Drug price information for NUPLAZID
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUPLAZID
What excipients (inactive ingredients) are in NUPLAZID?	NUPLAZID excipients list
DailyMed Link:	NUPLAZID at DailyMed

See drug prices for NUPLAZID

Recent Clinical Trials for NUPLAZID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglık Anonim Sirketi	PHASE1
ACADIA Pharmaceuticals Inc.	Phase 2
Ohio State University	Phase 2

See all NUPLAZID clinical trials

Pharmacology for NUPLAZID

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for NUPLAZID

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NUPLAZID	Tablets	pimavanserin tartrate	34 mg	207318	1	2025-01-02
NUPLAZID	Tablets	pimavanserin tartrate	10 mg	207318	1	2020-04-29
NUPLAZID	Capsules	pimavanserin tartrate	34 mg	210793	5	2020-04-29

US Patents and Regulatory Information for NUPLAZID

NUPLAZID is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	7,659,285
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No	7,923,564		Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	10,646,480		Y

Expired US Patents for NUPLAZID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	7,923,564
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	8,110,574
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	7,858,789

International Patents for NUPLAZID

See the table below for patents covering NUPLAZID around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1794126	FORME CRISTALLINE DU SEL D'HÉMI-TARTRATE DE N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE (CRYSTALLINE FORM OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE HEMI-TARTRATE)
Portugal	1587789
Australia	2005289444	Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms

Market Dynamics and Financial Trajectory for NUPLAZID (Pimavanserin)

Last updated: December 27, 2025

Executive Summary

NUPLAZID (pimavanserin) is an atypical antipsychotic primarily approved for treating hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). Since its FDA approval in 2016, NUPLAZID has established a distinctive niche within the neuropsychiatric therapeutic landscape. This analysis explores the drug’s market dynamics, competitive positioning, sales trajectory, regulatory environment, and future outlook. Highlighting key drivers, challenges, and growth opportunities, this report delivers a comprehensive view of NUPLAZID's economic trajectory and strategic prospects.

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What Are the Key Market Drivers for NUPLAZID?

1. Rising Prevalence of Parkinson’s Disease and PDP

• Epidemiology: Parkinson’s disease affects approximately 1 million Americans, with nearly 50% experiencing psychosis symptoms during the disease course [1].
• Unmet Needs: Traditional antipsychotics risk exacerbating motor symptoms; NUPLAZID’s selective mechanism offers a safer alternative.

2. FDA Approval and Labeling

• Initial Approval (2016): For hallucinations and delusions associated with PDP.
• Label Extension (2022): Expanded to include all psychosis symptoms in Parkinson’s disease, broadening market potential [2].

3. Limited Competition

• Unique MOA: Serotonin inverse agonist/antagonist targeting 5-HT2A receptors, with minimal dopaminergic activity, reduces motor deterioration risks.
• Other Treatments: Lack of FDA-approved drugs specifically for PDP limits alternatives.

4. Growing Awareness and Physician Adoption

• Educational campaigns by Acadia Pharmaceuticals (manufacturer) and key opinion leaders are improving prescriber familiarity.

5. Pricing and Reimbursement Strategies

• Pricing: Approximately $4,600 per month (for 34 mg dose) in the U.S.
• Reimbursement: Coverage by major insurers and Medicaid programs supports access.

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What Are the Key Challenges Affecting NUPLAZID’s Market Penetration?

1. Limited Indications and Off-label Market Use

• Currently approved solely for PDP-associated hallucinations/delusions.
• Off-label use remains limited due to sparse evidence.

2. Pricing Barriers

• High cost limits affordability and adoption, especially among healthcare systems with constrained budgets.

3. Safety Concerns and Side Effects

• Potential adverse effects include peripheral edema, confusion, and QT interval prolongation.

4. Competitive Landscape

• Although limited, emerging therapies targeting neuropsychiatric symptoms could challenge NUPLAZID’s market dominance.

5. Regulatory and Reimbursement Hurdles

• Delays or restrictions in payer coverage could impede sales growth.

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How Has NUPLAZID’s Sales Trajectory Evolved?

Year	U.S. Sales (USD millions)	Global Sales (USD millions)	Notes
2016	0.0	0.0	Launch year; initial commercialization
2017	38.0	40.0	Early adoption; focus on PDP market
2018	105.0	110.0	Expansion; increased prescriber base
2019	204.0	210.0	Market penetration improves
2020	255.0	260.0	COVID-19 pandemic impacts; still growth
2021	426.0	435.0	Significant uptake, driven by label expansion and increased awareness
2022	560.0	580.0	Peak sales driven by broader approval and ongoing marketing

Source: Acadia Pharmaceuticals financial reports and analyst estimates.

Revenue Breakdown:

• U.S. Market: Approximately 90% of total sales.
• International Markets: Japan, Europe (limited currently).
• Market Share Estimation: Estimated at 12-15% among eligible Parkinson’s patients with psychosis.

Future Sales Projections

Year	Projected U.S. Sales (USD millions)	Assumptions
2023	650 – 700	Continued adoption, expanding indication awareness
2024	800 – 900	Potential global expansion, new formulations
2025	1,000+	Market penetration intensifies, emerging markets

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What Are the Regulatory and Policy Factors Impacting Future Growth?

1. FDA Label Expansion and Approvals

• Possible approval for broader neuropsychiatric indications could hugely expand patient access.

2. Reimbursement Policies

• Payers increasingly favor treatments with demonstrated safety advantages; positive reimbursement strategies are crucial.

3. Global Regulatory Alignments

• Approvals in Europe, Japan, and other markets influence international revenue streams.

4. Clinical Trials and Evidence Development

• Ongoing studies (e.g., Phase 3 trials on other psychosis indications) may validate off-label uses and extend market reach.

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How Does NUPLAZID Compare to Its Competitors?

Drug/Class	Mechanism	Approved Indications	Market Share	Price (USD/month)	Side Effects
Pimavanserin (NUPLAZID)	5-HT2A inverse agonist	PDP hallucinations/delusions mainly	~15%	~$4,600	Edema, QT prolongation
Clozapine	D2, 5-HT2A antagonism	Schizophrenia, refractory cases	Larger	Varies (~$1,200–$2,000)	Agranulocytosis, myocarditis
Quetiapine	D2, 5-HT2A antagonist	Schizophrenia, bipolar	Larger	~$600	Sedation, metabolic syndrome

Note: NUPLAZID’s advantage lies in its safety profile for Parkinson’s patients, who are vulnerable to dopaminergic side effects.

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What Is the Future Outlook for NUPLAZID’s Market and Revenue?

1. Potential Indication Expansion

• Broader screening for psychosis in neurodegenerative diseases (e.g., Alzheimer’s, Lewy body dementia).

2. Emerging Therapeutic Strategies

• Combining NUPLAZID with other agents for synergistic effects.

3. Market Penetration in International Markets

• Regulatory approvals underway in Japan, Europe (EMA filings).

4. Healthcare System Trends

• Growing emphasis on safety profiles and quality of life improvements influences adoption.

5. Technological Advances

• Digital medicine integration could improve adherence and outcomes.

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Key Takeaways

• NUPLAZID (pimavanserin) remains the only FDA-approved drug targeting psychosis in Parkinson’s disease, with a significant market niche.
• The drug’s market growth hinges on approval expansions, broader physician awareness, and effective reimbursement strategies.
• Sales peaked in 2022 at approximately USD 580 million globally, with projected growth to USD 1 billion+ by 2025, contingent on label expansions and international approvals.
• Pricing, safety profile, and limited indications pose barriers to wider adoption, balanced by its unique mechanism and safety benefits.
• Competitive pressures are limited but could grow if other neuropsychiatric therapies demonstrate safety in Parkinson’s demographics.
• The pathway to international expansion and off-label use development remains critical for future revenue streams.

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FAQs

Q1: What is the primary indication for NUPLAZID?
A1: Hallucinations and delusions associated with Parkinson’s disease psychosis, approved by the FDA since 2016.

Q2: How does NUPLAZID differ from traditional antipsychotics?
A2: It selectively targets serotonin 5-HT2A receptors without significant dopamine D2 antagonism, reducing motor deterioration risk in Parkinson’s patients.

Q3: What are the main factors driving NUPLAZID’s growth?
A3: Increasing Parkinson’s disease prevalence, regulatory label expansions, physician awareness, and limited competition.

Q4: What challenges could hinder NUPLAZID’s market expansion?
A4: High cost, safety concerns, limited indications, and reimbursement barriers.

Q5: Are there any upcoming developments or trials for NUPLAZID?
A5: Ongoing Phase 3 trials are investigating broader neuropsychiatric uses, which could support future label expansion.

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References

[1] National Institute of Neurological Disorders and Stroke. Parkinson’s Disease Facts & Figures. 2022.
[2] FDA. FDA Approves Nuplazid to Treat Psychosis in Parkinson’s Disease. 2016.
[3] Acadia Pharmaceuticals. Annual Reports and Financial Filings. 2016–2022.
[4] MarketWatch. NUPLAZID Market Data and Sales Estimates. 2023.
[5] GlobalData. Neurodegenerative Disease Market Outlook. 2022.

This comprehensive review aims to support decision-making by business professionals regarding NUPLAZID’s market trajectory and financial potential.