Generic Nuplazid Availability
Last updated on Apr 10, 2025.
Nuplazid is a brand name of pimavanserin, approved by the FDA in the following formulation(s):
NUPLAZID (pimavanserin tartrate - capsule;oral)
NUPLAZID (pimavanserin tartrate - tablet;oral)
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Manufacturer: ACADIA PHARMS INC
Approval date: April 29, 2016
Strength(s): EQ 17MG BASE (discontinued) [RLD] [AB] -
Manufacturer: ACADIA PHARMS INC
Approval date: June 28, 2018
Strength(s): EQ 10MG BASE [RLD] [AB]
Is there a generic version of Nuplazid available?
No. There is currently no therapeutically equivalent version of Nuplazid available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nuplazid. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Formulations of pimavanserin
Patent 10,449,185
Issued: October 22, 2019
Inventor(s): Tejwani Ravi & Abele Stephen Edward & Vizzotti Emanuel Joseph
Assignee(s): ACADIA Pharmaceuticals Inc.Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Patent expiration dates:
- August 27, 2038✓
- August 27, 2038
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Combination of pimavanserin and cytochrome P450 modulators
Patent 10,517,860
Issued: December 31, 2019
Inventor(s): Parkinson Andrew
Assignee(s): ACADIA Pharmaceuticals Inc.A method for treating a disease or disorder in a patient who is currently taking a cytochrome P450 inhibitor comprising administering to the patient a dose of pimavanserin or a pharmaceutical acceptable salt thereof, wherein the dose is at least 20% lower than a dose of pimavanserin or a pharmaceutical acceptable salt thereof that would otherwise have been recommended to the patient if the patient were not currently taking the cytochrome P450 inhibitor.
Patent expiration dates:
- March 23, 2037✓
- March 23, 2037
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Formulations of pimavanserin
Patent 10,646,480
Issued: May 12, 2020
Inventor(s): Tejwani Ravi & Abele Stephen Edward & Vizzotti Emanuel Joseph
Assignee(s): ACADIA Pharmaceuticals Inc.Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Patent expiration dates:
- August 27, 2038✓
- August 27, 2038
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Formulations of pimavanserin
Patent 10,849,891
Issued: December 1, 2020
Inventor(s): Tejwani Ravi & Abele Stephen Edward & Vizzotti Emanuel Joseph
Assignee(s): ACADIA Pharmaceuticals Inc.Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Patent expiration dates:
- August 27, 2038✓✓
- August 27, 2038
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Combination of pimavanserin and cytochrome P450 modulators
Patent 10,953,000
Issued: March 23, 2021
Inventor(s): Parkinson Andrew
Assignee(s): ACADIA Pharmaceuticals Inc.A method for treating a disease or disorder in a patient who is currently taking a cytochrome P450 inhibitor comprising administering to the patient a dose of pimavanserin or a pharmaceutical acceptable salt thereof, wherein the dose is at least 20% lower than a dose of pimavanserin or a pharmaceutical acceptable salt thereof that would otherwise have been recommended to the patient if the patient were not currently taking the cytochrome P450 inhibitor.
Patent expiration dates:
- March 23, 2037✓
- March 23, 2037
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Formulations of pimavanserin
Patent 11,452,721
Issued: September 27, 2022
Inventor(s): Tejwani; Ravindra et al.
Assignee(s): ACADIA Pharmaceuticals Inc. (San Diego, CA)Provided herein are capsules containing pimavanserin, processes for manufacturing said capsule, and pharmaceutical compositions containing pimavanserin.
Patent expiration dates:
- August 27, 2038✓
- August 27, 2038
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Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent 7,601,740
Issued: October 13, 2009
Inventor(s): Weiner; David M. et al.
Assignee(s): Acadia Pharmaceuticals, Inc. (San Diego, CA)Behavioral pharmacological data with the compound of formula (I), a novel and selective 5HT2A/2C receptor inverse agonist, demonstrate in vivo efficacy in models of psychosis and dyskinesias. This includes activity in reversing MK-801 induced locomotor behaviors, suggesting that this compound may be an efficacious anti-psychotic, and activity in an MPTP primate model of dyskinesias, suggesting efficacy as an anti-dyskinesia agent. These data support the hypothesis that 5HT2A/2C receptor inverse agonism may confer antipsychotic and anti-dyskinetic efficacy in humans, and indicate a use of the compound of formula (I) and related agents as novel therapeutics for Parkinson's Disease, related human neurodegenerative diseases, and psychosis.
Patent expiration dates:
- April 29, 2030✓✓
- April 29, 2030
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Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Patent 7,659,285
Issued: February 9, 2010
Inventor(s): Weiner; David M. et al.
Assignee(s): Acadia Pharmaceuticals, Inc. (San Diego, CA)Behavioral pharmacological data with the compound of formula (I), a novel and selective 5HT2A/2C receptor inverse agonist, demonstrate in vivo efficacy in models of psychosis and dyskinesias. This includes activity in reversing MK-801 induced locomotor behaviors, suggesting that this compound may be an efficacious anti-psychotic, and activity in an MPTP primate model of dyskinesias, suggesting efficacy as an anti-dyskinesia agent. These data support the hypothesis that 5HT2A/2C receptor inverse agonism may confer antipsychotic and anti-dyskinetic efficacy in humans, and indicate a use of the compound of formula (I) and related agents as novel therapeutics for Parkinson's Disease, related human neurodegenerative diseases, and psychosis.
Patent expiration dates:
- August 24, 2026✓
- August 24, 2026
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N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Patent 7,732,615
Issued: June 8, 2010
Inventor(s): Thygesen; Mikkel Boas et al.
Assignee(s): ACADIA Pharmaceuticals Inc. (San Diego, CA)Disclosed herein are methods for synthesizing N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)-p- henylmethyl)carbamide. Also disclosed herein is the hemi-tartrate salt of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2 -methylpropyloxy)-phenylmethyl)carbamide and methods for obtaining the salt. Further disclosed are various crystalline forms of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)-p- henylmethyl)carbamide and its hemi-tartrate salt including various polymorphs and solvates.
Patent expiration dates:
- June 3, 2028✓✓
- June 3, 2028
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Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Patent 7,923,564
Issued: April 12, 2011
Inventor(s): Thygesen; Mikkel Boas et al.
Assignee(s): ACADIA Pharmaceuticals, Inc. (San Diego, CA)Disclosed herein are methods for synthesizing N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)-p- henylmethyl)carbamide. Also disclosed herein is the hemi-tartrate salt of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)-p- henylmethyl)carbamide and methods for obtaining the salt. Further disclosed are various crystalline forms of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)-p- henylmethyl)carbamide and its hemi-tartrate salt including various polymorphs and solvates.
Patent expiration dates:
- September 26, 2025✓✓
- September 26, 2025
More about Nuplazid (pimavanserin)
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
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