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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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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

Drug patent expirations by year for NUPLAZID

Recent Clinical Trials for NUPLAZID

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

Sponsor	Phase
ACADIA Pharmaceuticals Inc.	Phase 2
Ohio State University	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.

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

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

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
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Patent Expiration: ⤷ Sign Up

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Glossary

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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		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

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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	⤷ Sign Up	⤷ Sign Up
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	⤷ 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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20070083800	SALTS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL) CARBAMIDE AND THEIR PREPARATION	⤷ Sign Up
Spain	2367135		⤷ Sign Up
South Korea	101260036		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration