Details for New Drug Application (NDA): 207318

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NDA 207318 describes NUPLAZID, which is a drug marketed by Acadia Pharms Inc and is included in two NDAs. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the NUPLAZID profile page.

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.

Summary for 207318

Tradename:	NUPLAZID
Applicant:	Acadia Pharms Inc
Ingredient:	pimavanserin tartrate
Patents:	10

Pharmacology for NDA: 207318

Suppliers and Packaging for NDA: 207318

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318	NDA	Acadia Pharmaceuticals Inc.	63090-100	63090-100-30	30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 17MG BASE
Approval Date:	Apr 29, 2016	TE:		RLD:	Yes
Patent:	10,028,944	Patent Expiration:	Jan 15, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF HALLUCINATIONS AND DELUSIONS ASSOCIATED WITH PARKINSON'S DISEASE PSYCHOSIS
Patent:	7,601,740	Patent Expiration:	Apr 29, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	7,659,285	Patent Expiration:	Aug 24, 2026	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARKINSON'S DISEASE PSYCHOSIS

Expired US Patents for NDA 207318

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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	8,921,393	⤷ Subscribe
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	8,618,130	⤷ Subscribe
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318-001	Apr 29, 2016	10,028,944	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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