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 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 nineteen patent family members in twenty-three countries.

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

Summary for pimavanserin tartrate

International Patents:	119
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
Patent Applications:	130
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
ACADIA Pharmaceuticals Inc.	Phase 2
ACADIA Pharmaceuticals Inc.	Phase 3
ACADIA Pharmaceuticals Inc.

See all pimavanserin tartrate clinical trials

Pharmacology for pimavanserin tartrate

Drug Class	Atypical Antipsychotic

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	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				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	CAPSULE;ORAL	210793-001	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				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				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				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 pimavanserin tartrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793-001	Jun 28, 2018	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	See Plans and Pricing	See Plans and Pricing
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-002	Jun 28, 2018	See Plans and Pricing	See Plans and Pricing
>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
European Patent Office	1263729	COMPOSES AZACYCLIQUES UTILISES DANS LE TRAITEMENT DE MALADIES LIEES A LA SEROTONINE (AZACYCLIC COMPOUNDS FOR USE IN THE TREATMENT OF SEROTONIN RELATED DISEASES)	See Plans and Pricing
China	101778821	Synthesis of n-(4-fluorobenzyl)-n-(l-methylpiperidin-4-yl)-n'-(4- (2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms	See Plans and Pricing
South Korea	20070083800	SALTS OF N-(4-FLUOROBENZYL)-N-(1-METHYLPIPERIDIN-4-YL)-N'-(4-(2-METHYLPROPYLOXY)PHENYLMETHYL) CARBAMIDE AND THEIR PREPARATION	See Plans and Pricing
Hong Kong	1126776	SELECTIVE SEROTONIN 2A/2C RECEPTOR INVERSE AGONISTS AS THERAPEUTICS FOR NEURODEGENERATIVE DISEASES	See Plans and Pricing
Mexico	2007003433	SINTESIS DE N-FLUOROBENCIL) -N- (1-METILPIPERIDIN-4-IL) -N'- (4- (2-METILPROPILOXI) FENILMETIL) CARBAMIDA Y SU SAL DE TARTRATO Y FORMAS CRISTALINAS. (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
Germany	602004016288		See Plans and Pricing
Russian Federation	2007115886	СИНТЕЗ N-(4-ФТОРБЕНЗИЛ)-N-(1-МЕТИЛПИПЕРИДИН-4-ИЛ)-N`-(2-МЕТИЛПРОПИЛОКСИ)ФЕНИЛМЕТИЛ)КАРБАМИДА, А ТАКЖЕ ЕГО ТАРТРАТА И КРИСТАЛЛИЧЕСКИХ ФОРМ	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.