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Last Updated: July 13, 2020

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NUPLAZID Drug Profile


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Which patents cover Nuplazid, and when can generic versions of Nuplazid launch?

Nuplazid is a drug marketed by Acadia Pharms Inc and is included in two NDAs. There are eighteen patents protecting this drug.

This drug has one hundred and forty-six patent family members in twenty-seven countries.

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.

US ANDA Litigation and Generic Entry Outlook for Nuplazid

Nuplazid was eligible for patent challenges on April 29, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 3, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for NUPLAZID
International Patents:146
US Patents:18
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 23
Clinical Trials: 3
Drug Prices: Drug price information for NUPLAZID
DailyMed Link:NUPLAZID at DailyMed
Drug patent expirations by year for NUPLAZID
Drug Prices for NUPLAZID

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Generic Entry Opportunity Date for NUPLAZID
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for NUPLAZID*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for NUPLAZID

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

SponsorPhase
ACADIA Pharmaceuticals Inc.Phase 4
Baylor College of MedicinePhase 4
University Hospital, Strasbourg, FrancePhase 2

See all NUPLAZID clinical trials

Pharmacology for NUPLAZID
Paragraph IV (Patent) Challenges for NUPLAZID
Tradename Dosage Ingredient NDA Submissiondate
NUPLAZID CAPSULE;ORAL pimavanserin tartrate 210793 2020-04-29
NUPLAZID TABLET;ORAL pimavanserin tartrate 207318 2020-04-29

US Patents and Regulatory Information for NUPLAZID

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 207318-001 Apr 29, 2016 DISCN Yes No   Start Trial   Start Trial   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-002 Jun 28, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
Acadia Pharms Inc NUPLAZID pimavanserin tartrate TABLET;ORAL 207318-001 Apr 29, 2016 DISCN Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Colorcon
Moodys
McKesson
Baxter

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.