NUPLAZID Drug Patent 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 nine patents protecting this drug and three Paragraph IV challenges.
This drug has eighty-eight patent family members in twenty-two 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.
DrugPatentWatch® 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 October 29, 2030. This may change due to patent challenges or generic licensing.
There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for NUPLAZID?
- What are the global sales for NUPLAZID?
- What is Average Wholesale Price for NUPLAZID?
Summary for NUPLAZID
| International Patents: | 88 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 12 |
| Patent Applications: | 120 |
| Drug Prices: | Drug price information for NUPLAZID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for NUPLAZID |
| What excipients (inactive ingredients) are in NUPLAZID? | NUPLAZID excipients list |
| DailyMed Link: | NUPLAZID at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
| Sponsor | Phase |
|---|---|
| Humanis Saglık Anonim Sirketi | PHASE1 |
| Ohio State University | Phase 2 |
| ACADIA Pharmaceuticals Inc. | Phase 2 |
Pharmacology for NUPLAZID
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for NUPLAZID
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| NUPLAZID | Tablets | pimavanserin tartrate | 34 mg | 207318 | 1 | 2025-01-02 |
| 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 NUPLAZID
NUPLAZID is protected by nine US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUPLAZID is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| 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 | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-002 | Jun 28, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | TABLET;ORAL | 207318-001 | Apr 29, 2016 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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 NUPLAZID
| 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 | 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 | 207318-002 | Jun 28, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Acadia Pharms Inc | NUPLAZID | pimavanserin tartrate | CAPSULE;ORAL | 210793-001 | 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 |
International Patents for NUPLAZID
See the table below for patents covering NUPLAZID around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 407117 | ⤷ Start Trial | |
| Austria | 512136 | ⤷ Start Trial | |
| Australia | 2004206886 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases | ⤷ Start Trial |
| Brazil | PI0406591 | Composição, métodos para o tratamento de uma doença neurodegenerativa, disquinesia, distonia, mioclonias ou tremores, psicose, de uma doença neuropsiquiátria, de uma condição doentia e enxaqueca, composto, métodos de inibição da atividade de um receptor de monoamina e da ativação de um receptor de monoamina métodos de identificação de polimorfismo genético e de um paciente apropriado para tratamento com o composto | ⤷ Start Trial |
| Canada | 2512639 | AGONISTES INVERSES SELECTIFS POUR LE RECEPTEUR DE LA SEROTONINE 2A/2C UTILISES COMME AGENTS THERAPEUTIQUES CONTRE LES MALADIES NEURODEGENERATIVES (SELECTIVE SEROTONIN 2A/2C RECEPTOR INVERSE AGONISTS AS THERAPEUTICS FOR NEURODEGENERATIVE DISEASES) | ⤷ Start Trial |
| China | 101780080 | Selective serotonin 2a/2c receptor inverse agonists as therapeutics for neurodegenerative diseases | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
DrugChatter Q&A for NUPLAZID
Acadia pharmaceuticals nuplazid 721 patent ruling delaware court may 2025?
Aurobindo nuplazid patent lawsuit delaware court?
Acadia pharmaceuticals nuplazid 721 patent ruling delaware court?
Acadia pharmaceuticals msn aurobindo nuplazid patent litigation status may 2025?
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.
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