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Last Updated: June 23, 2024

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NUPLAZID Drug Patent Profile


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When do Nuplazid patents expire, 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

See drug prices for NUPLAZID

Recent Clinical Trials for NUPLAZID

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

SponsorPhase
ACADIA Pharmaceuticals Inc.Phase 2
Ohio State UniversityPhase 2
State University of New York - Downstate Medical CenterEarly Phase 1

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.

Patents protecting NUPLAZID

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

Formulations of pimavanserin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Formulations of pimavanserin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations of pimavanserin
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS

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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PSYCHOSIS OR A SYMPTOM THEREOF

Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 CAPSULE;ORAL 210793-001 Jun 28, 2018 ⤷  Sign Up ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018 ⤷  Sign Up ⤷  Sign Up
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 ⤷  Sign Up ⤷  Sign Up
>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
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 ⤷  Sign Up
South Africa 201000714 Salts of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl) carbamide and their preparation ⤷  Sign Up
Canada 2580129 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) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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