Pimavanserin tartrate - Generic Drug Details

What are the generic sources for pimavanserin tartrate and what is the scope of freedom to operate?

Pimavanserin tartrate is the generic ingredient in two branded drugs marketed by Acadia Pharms Inc, MSN, and Zydus, and is included in five NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pimavanserin tartrate has eighty-eight patent family members in twenty-two countries.

There are two drug master file entries for pimavanserin tartrate. One supplier is listed for this compound.

Summary for pimavanserin tartrate

International Patents:	88
US Patents:	10
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pimavanserin tartrate
What excipients (inactive ingredients) are in pimavanserin tartrate?	pimavanserin tartrate excipients list
DailyMed Link:	pimavanserin tartrate at DailyMed

Recent Clinical Trials for pimavanserin tartrate

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

Sponsor	Phase
Tasly Pharmaceutical Group Co., Ltd	Phase 3
ACADIA Pharmaceuticals Inc.	Phase 2
ACADIA Pharmaceuticals Inc.	Phase 3

See all pimavanserin tartrate clinical trials

Pharmacology for pimavanserin tartrate

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for pimavanserin tartrate

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PIMAVANSERIN TARTRATE

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 pimavanserin tartrate

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			Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes
Zydus	PIMAVANSERIN	pimavanserin tartrate	TABLET;ORAL	214502-001	Jan 16, 2024		DISCN	No	No
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No			Y	Y

Expired US Patents for pimavanserin tartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018

International Patents for pimavanserin tartrate

Country	Patent Number	Title	Estimated Expiration
Mexico	2007003433	SINTESIS DE N-FLUOROBENCIL) -N- (1-METILPIPERIDIN-4-IL) -N'- (4- (2-METILPROPILOXI) FENILMETIL) CARBAMIDA Y SU SAL DE TARTRATO Y FORMAS CRISTALINAS. (SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4- (2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND ITS TARTRATE SALT AND CRYSTALLINE FORMS.)
China	101778821	Synthesis of n-(4-fluorobenzyl)-n-(l-methylpiperidin-4-yl)-n'-(4- (2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
Hong Kong	1083759	SELECTIVE SEROTONIN 2A/2C RECEPTOR INVERSE AGONISTS AS THERAPEUTICS FOR NEURODEGENERATIVE DISEASES
South Africa	200702349	Synthesis of N- (4 - fluorobenzyl) - N - (1 - methylpiperidin - 4 yl) - N' - (4- (2 - methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
South Korea	101260036
Singapore	157378	SALTS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-NÆ-(4-(2- METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND THEIR PREPARATION
Canada	2580129	SELS DE N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE ET LEUR PREPARATION (SALTS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND THEIR PREPARATION)

Market Dynamics and Financial Trajectory for Pimavanserin Tartrate

Last updated: July 28, 2025

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Introduction

Pimavanserin tartrate represents a novel class of antipsychotic agents specifically approved for the treatment of Parkinson’s Disease Psychosis (PDP). Since its 2016 approval by the U.S. Food and Drug Administration (FDA), it has gained attention for addressing unmet needs in neuropsychiatric care. Analyzing its market dynamics and financial trajectory involves assessing the therapeutic landscape, competitive positioning, regulatory environment, sales performance, and evolving development pipeline.

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Therapeutic Indication and Medical Need

Parkinson’s Disease (PD), a progressive neurodegenerative disorder, affects over 10 million worldwide, predominantly impacting older populations [1]. Psychosis, characterized by hallucinations and delusions, complicates disease management, affecting approximately 40-60% of PD patients over their lifetime [2].

Historically, treatment options for Parkinson’s Disease Psychosis have been limited, with many antipsychotics exacerbating motor symptoms or inducing serious adverse effects. Pimavanserin’s unique mechanism—a selective serotonin 5-HT₂A receptor inverse agonist—targets psychosis without impairing dopaminergic pathways, making it a significant therapeutic advance [3].

Market Dynamics

Competitive Landscape

The initial market entrant, marketed as Nuplazid (pimavanserin tartrate), faces limited direct competition. Traditional antipsychotics like clozapine and quetiapine are off-label, often associated with worsening motor symptoms or adverse effects in PD patients [4]. Other drug candidates remain in development, but none have secured FDA approval for PDP.

Recent developments include investigational drugs targeting similar pathways or promising alternative mechanisms. However, as of 2023, Nuplazid maintains a dominant market position due to first-mover advantage and established efficacy data.

Regulatory Environment

Regulatory approvals have been pivotal in shaping pricing and reimbursement strategies. The FDA granted Breakthrough Therapy Designation in 2014, facilitating accelerated development and review. Post-approval, the drug gained favorable formulary access, especially in the U.S., backed by comprehensive clinical trial data demonstrating safety and efficacy [5].

Healthcare payers, however, scrutinize price points and cost-effectiveness given the relatively niche market size. The high per-unit cost of Nuplazid (approximately $7,000/month) reflects its orphan drug status and limited competition.

Market Penetration Drivers

Key drivers include:

• Prevalence of PDP: As the primary treatment for a high-bailure rate unmet need, the market remains favorable.
• Physician Adoption: Neurologists and psychiatrists are increasingly comfortable prescribing Pimavanserin, facilitated by clinical guidelines endorsing its use.
• Reimbursement Policies: Favorable insurance coverage underpins steady sales growth in the U.S. and select international markets.
• Off-label Use and Extended Indications: Ongoing research examines Pimavanserin for other psychiatric conditions, broadening its potential market.

Financial Trajectory

Sales Performance

Since its launch, Pimavanserin has demonstrated a steadily increasing revenue stream. In 2022, sales surpassed $112 million globally, representing approximately 25% year-over-year growth [6]. The U.S. remains the primary revenue contributor, with sales driven by the aging population and rising awareness. International markets, including Europe and Japan, are expanding gradually, contingent on regulatory approvals.

Revenue Drivers and Limitations

Revenue growth hinges on:

• Market Penetration Rates: Currently estimated at about 25-30% among eligible PD psychosis patients, with growth restrained by off-label trapping and physician caution.
• Pricing Strategies: The premium pricing model sustains margins but invites scrutiny and potential price regulation pressures.
• Reimbursement Landscape: Payers’ acceptance influences prescription volume; any policy shifts toward cost containment could temper growth.

Research & Development and Pipeline

Novartis continues investment in exploring Pimavanserin's broader therapeutic applications, notably in Alzheimer’s Disease Psychosis and Major Depressive Disorder. Positive clinical trial outcomes could catalyze new indications, expanding market scope and revenue potential.

Simultaneously, maintaining patent exclusivity until 2028 offers critical protection, although biosimilar or generic entrants could challenge pricing before then.

Market Challenges and Opportunities

• Challenges: Slow adoption in some markets, high drug costs, limited patient pool, and possible regulatory drag from cost-effectiveness evaluations.
• Opportunities: Expanding into new indications, geographic expansion, and leveraging the drug’s unique mechanism to develop combination therapies.

Future Outlook

The financial trajectory of Pimavanserin tartrate is expected to remain positive over the next five years, driven by steady sales, expanded indications, and increasing clinical adoption. However, growth margins may face pressure from pricing disputes, reimbursement changes, and potential competition emerging from pipeline candidates.

The global neurodegenerative disorder market's expansion signifies an encouraging environment for continued investment, particularly with proactive strategies to enhance market reach, patient access, and drug efficacy.

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Key Takeaways

• Pimavanserin tartrate addresses a significant unmet need in Parkinson’s Disease Psychosis, positioning it as a valuable asset in neuropsychiatric pharmacotherapy.
• The drug’s first-mover advantage, combined with effective regulatory and reimbursement strategies, underpins its robust financial trajectory.
• Market growth is constrained by a limited patient pool, pricing policies, and competitive developments, but expanding indications and geographic footprint offer upside.
• The ongoing clinical pipeline sustains long-term revenue prospects, contingent on regulatory approvals and clinical success.
• Cost-management strategies and differentiated positioning will be paramount for maintaining profitability amid an evolving pharmaceutical landscape.

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FAQs

1. What is the primary mechanism of action of Pimavanserin?
Pimavanserin selectively targets serotonin 5-HT₂A receptors, acting as an inverse agonist, which helps reduce psychosis symptoms without affecting dopaminergic pathways associated with motor control.

2. How does Pimavanserin differ from traditional antipsychotics?
Unlike conventional antipsychotics, Pimavanserin does not block dopamine receptors, minimizing the risk of worsening motor symptoms in Parkinson’s patients.

3. What are the main barriers to market expansion for Pimavanserin?
Barriers include high drug costs, limited awareness, cautious physician prescribing practices, and regulatory or reimbursement hurdles in international markets.

4. Are there ongoing clinical trials for Pimavanserin beyond Parkinson’s Disease Psychosis?
Yes, current trials are exploring efficacy in Alzheimer’s Disease Psychosis, depression, and other neuropsychiatric conditions, potentially broadening its use.

5. What is the patent status of Pimavanserin, and how does it affect future revenue?
Patent protection extends until 2028; nearing expiry could invite biosimilar competition, impacting pricing and margins unless new indications or formulations are developed.

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References

1. World Health Organization. “Neurological Disorders: Public Health Challenges.” 2021.
2. Nath, An N., et al. “Prevalence of Psychosis in Parkinson’s Disease.” Parkinsonism & Related Disorders, 2018.
3. Marston, Heather M., et al. “Pimavanserin: A Review in Parkinson’s Disease Psychosis.” Drugs, 2017.
4. International Parkinson and Movement Disorder Society. “Treatment of Parkinson’s Disease Psychosis.” 2020.
5. FDA. “Pimavanserin for Parkinson’s Disease Psychosis (Nuplazid).” 2016.
6. Novartis Financial Reports, 2022.