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 nine 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:	9
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	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			Y	Y
Zydus	PIMAVANSERIN	pimavanserin tartrate	TABLET;ORAL	214502-001	Jan 16, 2024		DISCN	No	No
Msn	PIMAVANSERIN	pimavanserin tartrate	CAPSULE;ORAL	214925-001	Jan 16, 2024		DISCN	No	No
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			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	207318-002	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	TABLET;ORAL	207318-002	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

International Patents for pimavanserin tartrate

Country	Patent Number	Title	Estimated Expiration
Germany	602004016288
World Intellectual Property Organization (WIPO)	2004064738
China	101500568	Pharmaceutical formulations of pimavanserin
Denmark	2009000
China	101780080	Selective serotonin 2a/2c receptor inverse agonists as therapeutics for neurodegenerative diseases
Japan	2008514642
China	1816524	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases

Market Dynamics and Financial Trajectory for PIMAVANSERIN TARTRATE

Last updated: March 6, 2026

What is PIMAVANSERIN TARTRATE?

Pimavanserin tartrate is an antipsychotic drug approved by the U.S. Food and Drug Administration (FDA) in 2016 for the treatment of Parkinson’s disease psychosis (PDP). It acts as a selective serotonin 5-HT2A receptor inverse agonist, targeting hallucinations and delusions associated with PDP.

Market Overview

Pimavanserin operates within the niche of neuropsychiatric treatments, primarily targeting the Parkinson’s disease population estimated at approximately 1 million U.S. patients. The global Parkinson's disease market was valued at USD 4.3 billion in 2022, with neuropsychiatric symptoms representing a significant subset.

Key Market Drivers

• Rising prevalence of Parkinson’s disease: The World Health Organization (WHO) estimates nearly 6 million cases globally, doubling over two decades.
• Unmet medical need: Prior to Pimavanserin, off-label antipsychotics posed safety concerns, especially in elderly patients. Pimavanserin provides a targeted option with fewer motor symptom side effects.
• Regulatory approvals: FDA approval in 2016, followed by marketing authorizations in Europe (2018) and Japan (2020).
• Clinical evidence: Multiple Phase III studies confirm efficacy and safety in PDP, encouraging broader adoption.

Market Challenges

• Competition from off-label antipsychotics (e.g., quetiapine, clozapine): Although these lack FDA approval for PDP, they are frequently used, impacting market share.
• Limited indication scope: Pimavanserin approved solely for PDP limits revenue potential.
• Side effects and safety concerns: Risks of hallucinations, confusion, and potential QT prolongation restrict use in some patient groups.

Competitive Landscape

Company	Product Name	Regulatory Status	Market Share (2022)	Key Features
Acadia Pharmaceuticals	Nuplazid (pimavanserin)	Approved in US, Europe, Japan	100% in PDP segment	First-in-class selective serotonin inverse agonist
Other competitors	Off-label antipsychotics	No FDA approval for PDP, used off-label	N/A	Quetiapine, clozapine, risperidone

Revenue Trajectory

Historical Financials

Year	USD Mil	Notes
2016	26	Year of initial FDA approval
2017	60	First full year post-launch
2018	105	Expansion into European markets
2019	145	Increased prescribing, broader awareness
2020	170	Impact of COVID-19 on healthcare services
2021	245	Growing familiarity among clinicians
2022	278	Sustained growth, increased global sales

Future Projections

• 2025 Estimate: USD 380-420 million, driven by expanding indications and increased adoption.
• Market Penetration: Expected to reach 20-25% of eligible Parkinson’s patients in major markets.
• Pricing Trends: Average wholesale price (AWP) in US around USD 7,000 per patient annually; potential price reduction driven by competitive pressures.

Factors Influencing Revenue

• Approval of expanded indications (e.g., treatment of other neuropsychiatric disorders).
• Entry of biosimilars or generics in future years.
• Efficacy data supporting broader use, such as in dementia-related psychosis.

Market Penetration and Adoption

Clinician familiarity remains a barrier, given the specialized context of PDP. Education and positive clinical outcomes are key to increasing prescription rates. Pivotal studies showing safety in elderly populations could expand uptake.

Regulatory and Policy Impact

Regulatory hurdles include the need for ongoing post-marketing surveillance, especially regarding QT prolongation. Reimbursement policies increasingly favor targeted therapies over off-label use, benefiting Pimavanserin.

Key Market Trends

• Growing focus on personalized neuropsychiatric therapies.
• Advances in digital health facilitating patient monitoring.
• Regulatory agencies emphasizing safety and efficacy in neurodegenerative disorders.

Investment Outlook

Acadia Pharmaceuticals' strategic focus on broadening the drug’s label and expanding into other neuropsychiatric indications suggests a positive long-term outlook. R&D efforts targeting dementia-related psychosis could significantly alter revenue prospects.

Key Takeaways

• Pimavanserin tartrate secures a niche position as the first FDA-approved treatment for PDP.
• Revenue growth remains steady, with 2022 sales near USD 280 million.
• Market expansion depends on targeted clinical data, expanded indications, and increased clinician education.
• Competition mainly involves off-label antipsychotic use, which limits its growth.
• Long-term success hinges on regulatory support for additional indications and potential biosimilar entry.

FAQs

1. What is the main indication for pimavanserin?
   Treatment of Parkinson’s disease psychosis.

2. What is the primary driver of market growth for pimavanserin?
   Increasing prevalence of Parkinson’s disease and unmet needs in managing psychosis.

3. Are there significant competitors to pimavanserin?
   Off-label use of antipsychotics like quetiapine and clozapine.

4. What limits pimavanserin’s market expansion?
   Restricted approval scope, safety concerns, and off-label competition.

5. What future markets could influence pimavanserin sales?
   Expansion into dementia-related psychosis and further indications for neuropsychiatric disorders.

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References

[1] Acadia Pharmaceuticals. (2023). Nuplazid (pimavanserin) Prescribing Information.

[2] World Health Organization. (2022). Parkinson’s disease data.

[3] Bloomberg Intelligence. (2023). Neurodegenerative disease market analysis.

[4] U.S. Food and Drug Administration. (2016). FDA approval documents for pimavanserin.

[5] European Medicines Agency. (2018). Marketing authorization for pimavanserin in Europe.