Pimavanserin tartrate - Generic Drug Details

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

Pimavanserin tartrate is the generic ingredient in two branded drugs marketed by Acadia Pharms Inc, MSN, and Zydus, and is included in five NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pimavanserin tartrate has eighty-eight patent family members in twenty-two countries.

There are two drug master file entries for pimavanserin tartrate. One supplier is listed for this compound.

Summary for pimavanserin tartrate

International Patents:	88
US Patents:	14
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Applications:	118
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for pimavanserin tartrate
What excipients (inactive ingredients) are in pimavanserin tartrate?	pimavanserin tartrate excipients list
DailyMed Link:	pimavanserin tartrate at DailyMed

Recent Clinical Trials for pimavanserin tartrate

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

Sponsor	Phase
Tasly Pharmaceutical Group Co., Ltd	Phase 3
ACADIA Pharmaceuticals Inc.	Phase 2
ACADIA Pharmaceuticals Inc.	Phase 3

See all pimavanserin tartrate clinical trials

Pharmacology for pimavanserin tartrate

Drug Class	Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for pimavanserin tartrate

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PIMAVANSERIN TARTRATE

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 pimavanserin tartrate

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

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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	207318-001	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 pimavanserin tartrate

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Country	Patent Number	Title	Estimated Expiration
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	⤷ Sign Up
China	102028949	Selective serotonin 2a/2c receptor inverse agonists as therapeutics for neurodegenerative diseases	⤷ Sign Up
European Patent Office	2289879	Synthèse d'une forme cristalline du sel de tartrate de n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide (Synthesis of a crystalline form of n-(4-fluorobenzyl)-n-(1-methylpiperidin-4-yl)-n'-(4-(2-methylpropyloxy)phenylmethyl)carbamide tartrate salt)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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