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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 fourteen patents protecting this drug and two 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 nine 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:	14
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	11
Patent Applications:	58
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
Ohio State University	Phase 2
ACADIA Pharmaceuticals Inc.	Phase 2
ACADIA Pharmaceuticals Inc.	Early Phase 1

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	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 fourteen 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	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No	7,732,615		Y	Y
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	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	8,921,393
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes	9,566,271
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016		DISCN	Yes	No	8,618,130
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	11,452,721		Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes	10,028,944

Expired US Patents for NUPLAZID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	9,566,271
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	6,756,393
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	8,921,393
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	7,858,789
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	9,296,694
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	10,028,944

International Patents for NUPLAZID

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

Country	Patent Number	Title	Estimated Expiration
Canada	2512639	AGONISTES INVERSES SELECTIFS POUR LE RECEPTEUR DE LA SEROTONINE 2A/2C UTILISES COMME AGENTS THERAPEUTIQUES CONTRE LES MALADIES NEURODEGENERATIVES (SELECTIVE SEROTONIN 2A/2C RECEPTOR INVERSE AGONISTS AS THERAPEUTICS FOR NEURODEGENERATIVE DISEASES)
Spain	2314362
South Africa	201000714	Salts of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl) carbamide and their preparation
Australia	2005202257
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
Russian Federation	2465267	СЕЛЕКТИВНЫЕ ОБРАТНЫЕ АГОНИСТЫ СЕРОТОНИН 2А/2С РЕЦЕПТОРА, ПРИМЕНЯЕМЫЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ ПРИ НЕЙРОДЕГЕНЕРАТИВНЫХ ЗАБОЛЕВАНИЯХ (SELECTIVE INVERSE SEROTONIN 2A/2C RECEPTOR AGONISTS APPLICABLES AS THERAPEUTIC AGENTS FOR NEURODEGENERATIVE DISORDERS)
Russian Federation	2002118705

NUPLAZID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NUPLAZID

Introduction

NUPLAZID, developed by Acadia Pharmaceuticals, is a groundbreaking drug primarily used for the treatment of psychosis associated with Parkinson’s disease. Here, we will delve into the market dynamics and financial trajectory of NUPLAZID, highlighting its performance, growth drivers, and future outlook.

Market Performance of NUPLAZID

Quarterly and Annual Sales

NUPLAZID has consistently shown strong sales performance over the years. In the third quarter of 2023, net product sales of NUPLAZID were $144.8 million, an increase of approximately $14 million compared to the same period in 2022. This growth was attributed to several factors, including a $7 million reduction in in-channel inventory from the prior year, $4 million from lower 340B volumes, and $3 million from 2% demand bottle growth[1].

For the full year 2023, NUPLAZID sales reached $549.2 million, a 6% increase from $517.2 million in 2022. This growth was driven by increases in unit sales and a higher average net selling price[4].

Recent Trends

In the first quarter of 2024, NUPLAZID sales continued to grow, reaching $129.9 million, a 10% increase from $118.5 million in the first quarter of 2023. This increase was due to 6% sell-in growth and a 4% net price benefit[2].

The second quarter of 2024 saw NUPLAZID sales rise by 11% year-over-year, reaching $157.4 million. This robust growth underscores the drug's strong market position[3].

Growth Drivers

Clinical Efficacy and Market Demand

NUPLAZID's efficacy in treating psychosis associated with Parkinson’s disease has been a significant driver of its market success. The drug addresses a critical unmet need, providing relief to patients suffering from this debilitating condition.

Competitive Landscape

NUPLAZID holds a unique position in the market as it is the only FDA-approved treatment for psychosis associated with Parkinson’s disease. This lack of direct competition has contributed to its strong sales performance.

Pricing and Reimbursement

The higher average net selling price in 2023 compared to 2022 has also contributed to the revenue growth of NUPLAZID. Additionally, favorable reimbursement policies have helped in maintaining and increasing market share[4].

Financial Trajectory

Revenue Projections

For 2024, Acadia Pharmaceuticals has updated its guidance, projecting NUPLAZID sales to be in the range of $590-$610 million. This is an increase from the previous year's sales, reflecting continued growth and market penetration[3].

Operating Expenses

The increase in selling, general, and administrative (SG&A) expenses has been a notable factor in the financial trajectory of NUPLAZID. These expenses have risen due to increased commercial costs associated with the launch of other products like DAYBUE, but have been partially offset by reductions in expenses related to NUPLAZID[1][4].

Net Income

The financial performance of Acadia Pharmaceuticals, driven in part by NUPLAZID, has shown significant improvement. In the second quarter of 2024, the company reported a net income of $33.4 million, a substantial increase from $1.1 million in the same period the previous year[3].

Future Outlook

Pipeline Expansion

While NUPLAZID remains a cornerstone of Acadia's portfolio, the company is expanding its pipeline with new treatments. This includes Phase 3 studies for Prader-Willi syndrome and Phase 2/3 studies for Alzheimer’s disease psychosis, which could potentially diversify revenue streams and further strengthen the company's market position[1].

Market Expansion

The continued growth of NUPLAZID is expected to be driven by its established market presence and the lack of direct competition. As the patient population with Parkinson’s disease continues to grow, so does the potential market for NUPLAZID.

Key Takeaways

• Consistent Sales Growth: NUPLAZID has shown consistent year-over-year sales growth, driven by its clinical efficacy and market demand.
• Strong Financial Performance: The drug has contributed significantly to Acadia Pharmaceuticals' revenue and net income.
• Competitive Advantage: As the only FDA-approved treatment for psychosis associated with Parkinson’s disease, NUPLAZID holds a unique market position.
• Future Projections: The company projects continued growth for NUPLAZID, with sales expected to be in the range of $590-$610 million for 2024.

FAQs

What is NUPLAZID used for?

NUPLAZID is used for the treatment of psychosis associated with Parkinson’s disease.

How has NUPLAZID performed in recent quarters?

In the third quarter of 2023, NUPLAZID sales were $144.8 million, and in the first quarter of 2024, sales were $129.9 million, showing a 10% increase from the same period in 2023[1][2].

What are the growth drivers for NUPLAZID?

The growth drivers include its clinical efficacy, lack of direct competition, and favorable pricing and reimbursement policies.

What are the projected sales for NUPLAZID in 2024?

Acadia Pharmaceuticals projects NUPLAZID sales to be in the range of $590-$610 million for 2024[3].

How does NUPLAZID contribute to Acadia Pharmaceuticals' financial performance?

NUPLAZID is a significant contributor to the company's revenue and net income, with its sales driving the company's financial growth and improving its net income[1][3].

Sources

1. Acadia Pharmaceuticals Reports Third Quarter 2023 Financial Results and Operating Overview - Biospace
2. Acadia Pharmaceuticals Reports First Quarter 2024 Financial Results and Operating Overview - Business Wire
3. Acadia Pharmaceuticals Reports Second Quarter 2024 Financial Results and Operating Overview - Stock Titan
4. Acadia Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Operating Overview - Acadia Pharmaceuticals
5. ACADIA Pharmaceuticals Reports First Quarter 2020 Financial Results - Nasdaq