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Last Updated: August 11, 2022

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 one hundred and nineteen patent family members in twenty-three 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 29, 2030. This may change due to patent challenges or generic licensing.

There have been six 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

See drug prices for NUPLAZID

DrugPatentWatch® Estimated Generic Entry Opportunity Date for NUPLAZID
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for NUPLAZID

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

SponsorPhase
VA Office of Research and DevelopmentPhase 2
University Hospital, Strasbourg, FrancePhase 2
EUCLID Clinical Trial PlatformPhase 2

See all NUPLAZID clinical trials

Pharmacology for NUPLAZID
Anatomical Therapeutic Chemical (ATC) Classes 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUPLAZID is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting NUPLAZID

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

Formulations of pimavanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination of pimavanserin and cytochrome P450 modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

Formulations of pimavanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations of pimavanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

Combination of pimavanserin and cytochrome P450 modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PARKINSON'S DISEASE PSYCHOSIS

N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF A NEURODEGENERATIVE DISEASE OR A SYMPTOM THEREOF

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

Methods of treatment using selective 5-HT2A inverse agonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

International Patents for NUPLAZID

When does loss-of-exclusivity occur for NUPLAZID?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04206886
Estimated Expiration: See Plans and Pricing

Austria

Patent: 7117
Estimated Expiration: See Plans and Pricing

Patent: 2136
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0406591
Estimated Expiration: See Plans and Pricing

Canada

Patent: 12639
Estimated Expiration: See Plans and Pricing

China

Patent: 16524
Estimated Expiration: See Plans and Pricing

Patent: 1780080
Estimated Expiration: See Plans and Pricing

Patent: 2028949
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08642
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87789
Estimated Expiration: See Plans and Pricing

Patent: 09000
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87789
Estimated Expiration: See Plans and Pricing

Patent: 09000
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004016288
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 83759
Estimated Expiration: See Plans and Pricing

Patent: 26776
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84777
Estimated Expiration: See Plans and Pricing

Patent: 06516284
Estimated Expiration: See Plans and Pricing

Patent: 10174026
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05007568
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1146
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87789
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 32401
Estimated Expiration: See Plans and Pricing

Patent: 65267
Estimated Expiration: See Plans and Pricing

Patent: 05125918
Estimated Expiration: See Plans and Pricing

Patent: 08115009
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 0617
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87789
Estimated Expiration: See Plans and Pricing

Patent: 09000
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0505680
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1095939
Estimated Expiration: See Plans and Pricing

Patent: 050094857
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14362
Estimated Expiration: See Plans and Pricing

Patent: 67135
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Brazil PI0406591 Composição, métodos para o tratamento de uma doença neurodegenerativa, disquinesia, distonia, mioclonias ou tremores, psicose, de uma doença neuropsiquiátria, de uma condição doentia e enxaqueca, composto, métodos de inibição da atividade de um receptor de monoamina e da ativação de um receptor de monoamina métodos de identificação de polimorfismo genético e de um paciente apropriado para tratamento com o composto See Plans and Pricing
China 101230034 See Plans and Pricing
Australia 2005202257 See Plans and Pricing
Singapore 161221 SYNTHESIS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-NÆ-(4-(2- METHYLPROPYLOXY)PHENYLMETHYL)CARBAMIDE AND ITS TARTRATE SALT AND CRYSTALLINE FORMS See Plans and Pricing
China 101035759 Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms See Plans and Pricing
European Patent Office 1794125 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.