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Last Updated: January 21, 2021

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Details for New Drug Application (NDA): 210793

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NDA 210793 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 210793
Applicant:Acadia Pharms Inc
Ingredient:pimavanserin tartrate
Generic Entry Opportunity Date for 210793
Generic Entry Date for 210793*:
Constraining patent/regulatory exclusivity:

*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 210793
Tradename Dosage Ingredient NDA Submissiondate
NUPLAZID CAPSULE;ORAL pimavanserin tartrate 210793 2020-04-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 34MG BASE
Approval Date:Jun 28, 2018TE: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:Aug 27, 2038Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 210793

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   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate CAPSULE;ORAL 210793-001 Jun 28, 2018   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Johnson and Johnson

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.