Pimavanserin tartrate - Generic Drug Details

What are the generic drug 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 Applications:	118
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	10,646,480		Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	10,849,891		Y
Zydus	PIMAVANSERIN	pimavanserin tartrate	CAPSULE;ORAL	214493-001	Jan 16, 2024		DISCN	No	No
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No	7,601,740		Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No	7,732,615		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	8,110,574
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	8,921,393
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	7,858,789
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	9,566,271
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	6,756,393

International Patents for pimavanserin tartrate

Country	Patent Number	Title	Estimated Expiration
Japan	2006516284
European Patent Office	2289879	Synthèse d'une forme cristalline du sel de tartrate de n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide (Synthesis of a crystalline form of n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide tartrate salt)
Russian Federation	2417986	СИНТЕЗ N-(4-ФТОРБЕНЗИЛ)-N-(1-МЕТИЛПИПЕРИДИН-4-ИЛ)-N'-(4-(2-МЕТИЛПРОПИЛОКСИ)ФЕНИЛМЕТИЛ)КАРБАМИДА, А ТАКЖЕ ЕГО ТАРТРАТА И КРИСТАЛЛИЧЕСКИХ ФОРМ (SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE, AS WELL AS TARTRATE AND CRYSTALLINE FORMS THEREOF)
Australia	2008254238	Synthesis of N-(4-fluorobenzyl)-N-(l-methylpiperidin-4-yl)-N'-(4- (2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
World Intellectual Property Organization (WIPO)	2006037043

Market Dynamics and Financial Trajectory for Pimavanserin Tartrate

Introduction

Pimavanserin tartrate, marketed under the brand name NUPLAZID, is an atypical antipsychotic approved by the FDA for the treatment of psychosis associated with Parkinson’s disease (PDP). Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its current status, future projections, and the factors influencing its market performance.

Market Size and Growth

The global pimavanserin market is projected to grow significantly over the next few years. As of 2022, the market size was valued at $1.504 billion, and it is expected to reach $2.1878 billion by 2029, with a Compound Annual Growth Rate (CAGR) of 5.5% during the period from 2023 to 2029[1].

Key Drivers

Several factors are driving the growth of the pimavanserin market:

• Demand from Hospitals and Clinics: The primary demand for pimavanserin comes from hospitals and clinics, particularly those specializing in neurology and psychiatry[1].
• Unmet Medical Needs: Pimavanserin addresses a significant unmet medical need for the treatment of PDP, a condition for which there were no FDA-approved treatments prior to its approval[3].
• Expansion into New Indications: Besides PDP, pimavanserin is being studied for the treatment of Alzheimer’s disease psychosis and other neurological disorders, which could further expand its market[3].

Regional Market Analysis

The market for pimavanserin is analyzed across various regions, including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. Here are some key insights:

• North America: This region is a significant market for pimavanserin due to the high prevalence of Parkinson’s disease and the presence of advanced healthcare infrastructure[1].
• Europe and Asia-Pacific: These regions also show promising growth due to increasing awareness and diagnosis of neurological disorders[1].

Product Application and Revenue Analysis

Pimavanserin's revenue is primarily generated from its application in treating PDP. Here are some details:

• Volume and Revenue: The global sales volume and revenue of pimavanserin have been increasing steadily. For instance, the sales in volume and value by region from 2018 to 2023 and the forecasted sales from 2024 to 2029 indicate a consistent growth trend[1].
• Price and Gross Margin: The price of pimavanserin, such as $3,646.80 for a bottle of 30 tablets, and its gross margin are critical factors in its revenue analysis. The gross margin has remained relatively stable, contributing to the overall revenue growth[2].

Clinical Trials and Efficacy

The efficacy of pimavanserin was established through several clinical trials:

• Study 020: This pivotal study, conducted in the U.S. and Canada, demonstrated the efficacy of pimavanserin in treating PDP. The study used centralized raters to reduce inter-rater variability and exclusively used the 40 mg dose, which contributed to its success[2][3].
• Previous Trials: Earlier trials, such as Study 012 and Study 014, faced challenges, including an enhanced placebo response and lack of significant improvement. However, these trials provided valuable insights that were incorporated into the design of Study 020[2].

Regulatory Approvals and Milestones

Pimavanserin has achieved several regulatory milestones:

• FDA Approval: Approved by the FDA in April 2016 for the treatment of PDP, pimavanserin was granted Breakthrough Therapy designation in 2014, which expedited its development and review process[3].
• License Agreements: Acadia Pharmaceuticals has a license agreement with the Ipsen Group, which includes intellectual property rights that complement pimavanserin. This agreement involved a one-time milestone payment of $8.0 million upon FDA approval[4].

Financial Performance of Acadia Pharmaceuticals

Acadia Pharmaceuticals, the company behind pimavanserin, has seen significant financial activity related to this drug:

• Revenue and Expenses: The company's financial reports show that while pimavanserin has generated substantial revenue, the overall net loss has been a challenge. For example, in the first quarter of 2021, the company reported a net loss of $66.448 million[4].
• Operating Expenses: The costs associated with research and development, selling, general, and administrative expenses are significant. However, these expenses are part of the company's strategy to commercialize and expand the use of pimavanserin[4].

Future Outlook and Expansion Plans

The future of pimavanserin looks promising with several expansion plans:

• Additional Indications: Acadia Pharmaceuticals is pursuing the development of pimavanserin for other neurological and psychiatric disorders, including Alzheimer’s disease psychosis and schizophrenia[3].
• Strategic Alliances: The company may establish strategic alliances to commercialize pimavanserin in selected markets outside the U.S.[3].
• Life Cycle Planning: Continuous life cycle planning and assessment of new development opportunities are key to the company's strategy to leverage the full potential of pimavanserin[3].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

• Market Competition: The pharmaceutical market is highly competitive, and companies need to innovate and adapt to stay competitive[1].
• Public Health Needs: The COVID-19 pandemic has highlighted the importance of agile and responsive public health strategies, which pharmaceutical companies must address[1].

Key Takeaways

• Growing Market: The global pimavanserin market is projected to grow at a CAGR of 5.5% from 2023 to 2029.
• Regulatory Approvals: Pimavanserin has received FDA approval for PDP and has Breakthrough Therapy designation.
• Financial Performance: While generating significant revenue, Acadia Pharmaceuticals faces net losses due to high operating expenses.
• Expansion Plans: The company is pursuing additional indications and strategic alliances to expand pimavanserin's market.

FAQs

What is pimavanserin tartrate used for?

Pimavanserin tartrate, marketed as NUPLAZID, is primarily used for the treatment of psychosis associated with Parkinson’s disease (PDP).

What is the current market size of pimavanserin?

As of 2022, the global pimavanserin market size was valued at $1.504 billion.

What is the projected growth rate of the pimavanserin market?

The market is expected to grow at a CAGR of 5.5% from 2023 to 2029.

Has pimavanserin been approved for any other indications besides PDP?

Currently, pimavanserin is approved only for PDP, but it is being studied for other indications such as Alzheimer’s disease psychosis and schizophrenia.

What are the major drivers for the pimavanserin market?

The major drivers include demand from hospitals and clinics, unmet medical needs, and potential expansion into new indications.

Sources

1. QYResearch: Global Pimavanserin Market Report, History and Forecast 2018-2029.
2. Texas Health and Human Services: Pimavanserin Monograph.
3. Acadia Pharmaceuticals: Improving Lives - Investors.
4. Acadia Pharmaceuticals: United States Securities and Exchange Commission - Form 10-Q.