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Last Updated: January 21, 2021

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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. There are eighteen 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. Additional details are available on the pimavanserin tartrate profile page.
Summary for 207318
Tradename:NUPLAZID
Applicant:Acadia Pharms Inc
Ingredient:pimavanserin tartrate
Patents:16
Generic Entry Opportunity Date for 207318
Generic Entry Date for 207318*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Paragraph IV (Patent) Challenges for 207318
Tradename Dosage Ingredient NDA Submissiondate
NUPLAZID TABLET;ORAL pimavanserin tartrate 207318 2020-04-29

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 17MG BASE
Approval Date:Apr 29, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 29, 2021
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Jan 15, 2024Product Flag?Substance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Mar 6, 2021Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 207318

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   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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