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Last Updated: December 25, 2024

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NUPLAZID Drug Patent Profile


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Which patents cover Nuplazid, and when can generic versions of Nuplazid launch?

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

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Drug patent expirations by year for NUPLAZID
Drug Prices for NUPLAZID

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Recent Clinical Trials for NUPLAZID

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

SponsorPhase
ACADIA Pharmaceuticals Inc.Phase 2
Ohio State UniversityPhase 2
ACADIA Pharmaceuticals Inc.Early Phase 1

See all NUPLAZID clinical trials

Pharmacology for NUPLAZID
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 ⤷  Subscribe Y Y ⤷  Subscribe
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No 7,601,740 ⤷  Subscribe Y Y ⤷  Subscribe
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 RX Yes Yes 8,921,393 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 207318-001 Apr 29, 2016 9,296,694 ⤷  Subscribe
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 6,756,393 ⤷  Subscribe
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 8,618,130 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NUPLAZID

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

Country Patent Number Title Estimated Expiration
Canada 2580136 SYNTHESE DE N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE, TARTRATE DE CE COMPOSE ET SESFORMES CRISTALLINES (SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND ITS TARTRATE SALT AND CRYSTALLINE FORMS) ⤷  Subscribe
Portugal 1587789 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2004064738 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

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

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