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Pimavanserin tartrate - Generic Drug Details

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What are the generic drug sources for pimavanserin tartrate and what is the scope of pimavanserin tartrate freedom to operate?

Pimavanserin tartrate is the generic ingredient in one branded drug marketed by Acadia Pharms Inc and is included in two NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pimavanserin tartrate has one hundred and forty-two patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for pimavanserin tartrate

International Patents:	142
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Clinical Trials:	3
DailyMed Link:	pimavanserin tartrate at DailyMed

Pharmacology for pimavanserin tartrate

Drug Class

Atypical Antipsychotic

Synonyms for pimavanserin tartrate

1-(4-Fluorobenzyl)-3-(4-isobutoxybenzyl)-1-(1-methylpiperidin-4-yl)urea ((2R,3R)-2,3-dihydroxysuccinate)(21)

1-(4-fluorobenzyl)-3-(4-isobutoxybenzyl)-1-(1-methylpiperidin-4-yl)urea (2R,3R)-2,3-dihydroxysuccinate

706782-28-7

868855-07-6

ACP 103

ACP-103

AK323731

AKOS027327334

Bis(1-(4-Fluorobenzyl)-1-(1-methylpiperidin-4-yl)-3-(4-(2-methylpropoxy)benzyl)urea) (2R,3R)-2,3-dihydroxybutanedioate

bis(4-{[(4-fluorophenyl)methyl]({[4-(2-methylpropoxy)phenyl]methyl}carbamoyl)amino}-1-methylpiperidin-1-ium) (2R,3R)-2,3-dihydroxybutanedioate

bis{N-[(4-fluorophenyl)methyl]-N-(1-methylpiperidin-4-yl)-N'-{[4-(2-methylpropoxy)phenyl]methyl}urea} (2R,3R)-2,3-dihydroxybutanedioate

CHEBI:133014

CS-7954

D08969

DTXSID50220958

HY-14557A

LS-193533

MolPort-006-170-072

N-(4-Fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl) carbamide (2R,3R)-dihydroxybutanedioate (2:1)

N-(4-Fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phenylmethyl)carbamide

NA83F1SJSR

Nuplazid

pimavanserin hemitartrate

Pimavanserin tartrate (USAN)

Pimavanserin tartrate [USAN]

SC-90507

UNII-NA83F1SJSR

Urea, N-((4-fluorophenyl)methyl)-N-(1-methyl-4-piperidinyl)-N'-((4-(2-methylpropoxy)phenyl)methyl)-, (2R,3R)-2,3-dihydroxybutanedioate (2:1)

US Patents and Regulatory Information for pimavanserin tartrate

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		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018		RX	Yes	Yes
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes			Y	Y
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018		RX	Yes	Yes

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Non-Orange Book US Patents for pimavanserin tartrate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,713,995	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
7,732,462	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
7,994,193	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
8,008,323	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
8,227,487	Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases

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International Patents for pimavanserin tartrate

Country	Document Number	Estimated Expiration
Japan	2010174026
Japan	5154227
World Intellectual Property Organization (WIPO)	2006036874
Denmark	2009000
Russian Federation	2008115009