Nuplazid Patent Expiration

Nuplazid is a drug owned by Acadia Pharmaceuticals Inc. It is protected by 21 US drug patents filed from 2016 to 2022. Out of these, 10 drug patents are active and 11 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 27, 2038. Details of Nuplazid's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7858789 Derivatives of 4-aminopiperidine and their use as a medicament
Dec, 2020

(3 years ago)

Expired
US8110574 Derivatives of 4-aminopiperidine and their use as a medicament
Dec, 2020

(3 years ago)

Expired
US6815458 Azacyclic compounds
Mar, 2021

(3 years ago)

Expired
US6756393 Azacyclic compounds
Mar, 2021

(3 years ago)

Expired
US9296694 Azacyclic compounds
Mar, 2021

(3 years ago)

Expired
US7115634 4-aminopiperidine and their use as a medicine
Oct, 2021

(2 years ago)

Expired
US7923564 Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N′-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Sep, 2025

(1 year, 2 months from now)

Active
US7732615 N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N′-(4-(2-methylpropyloxy)phenylmethyl)carbamide and its tartrate salt and crystalline forms
Jun, 2028

(3 years from now)

Active
US7601740 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Apr, 2030

(5 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9765053 Methods of treatment using selective 5-HT2A inverse agonists
Jul, 2022

(1 year, 11 months ago)

Expired
US8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Jan, 2024

(6 months ago)

Expired
US8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Jan, 2024

(6 months ago)

Expired
US10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Jan, 2024

(6 months ago)

Expired
US9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Jan, 2024

(6 months ago)

Expired
US7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Aug, 2026

(2 years from now)

Active
US10953000 Combination of pimavanserin and cytochrome P450 modulators
Mar, 2037

(12 years from now)

Active
US10517860 Combination of pimavanserin and cytochrome P450 modulators
Mar, 2037

(12 years from now)

Active
US10449185 Formulations of pimavanserin
Aug, 2038

(14 years from now)

Active
US10849891 Formulations of pimavanserin
Aug, 2038

(14 years from now)

Active
US10646480 Formulations of pimavanserin
Aug, 2038

(14 years from now)

Active
US11452721 Formulations of pimavanserin
Aug, 2038

(14 years from now)

Active


FDA has granted several exclusivities to Nuplazid. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nuplazid, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Nuplazid.

Exclusivity Information

Nuplazid holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Nuplazid's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 29, 2021

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Nuplazid is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nuplazid's family patents as well as insights into ongoing legal events on those patents.

Nuplazid's family patents

Nuplazid has patent protection in a total of 24 countries. It's US patent count contributes only to 38.3% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Nuplazid.

Family Patents

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Generic Launch

Generic Release Date:

Nuplazid's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 27, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Nuplazid Generics:

Pimavanserin Tartrate is the generic name for the brand Nuplazid. 2 different companies have already filed for the generic of Nuplazid, with Zydus having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nuplazid's generic

How can I launch a generic of Nuplazid before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Nuplazid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nuplazid's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Nuplazid -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
34 mg 29 Apr, 2020 5 27 Aug, 2038
10 mg 29 Apr, 2020 1 03 Jun, 2028




About Nuplazid

Nuplazid is a drug owned by Acadia Pharmaceuticals Inc. It is used for treating symptoms of neurodegenerative diseases such as Parkinson's psychosis and hallucinations. Nuplazid uses Pimavanserin Tartrate as an active ingredient. Nuplazid was launched by Acadia Pharms Inc in 2018.

Market Authorisation Date:

Nuplazid was approved by FDA for market use on 28 June, 2018.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Nuplazid is 28 June, 2018, its NCE-1 date is estimated to be 29 April, 2020

Active Ingredient:

Nuplazid uses Pimavanserin Tartrate as the active ingredient. Check out other Drugs and Companies using Pimavanserin Tartrate ingredient

Treatment:

Nuplazid is used for treating symptoms of neurodegenerative diseases such as Parkinson's psychosis and hallucinations.

Dosage:

Nuplazid is available in the following dosage forms - capsule form for oral use, tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 34MG BASE CAPSULE Prescription ORAL
EQ 17MG BASE TABLET Discontinued ORAL
EQ 10MG BASE TABLET Prescription ORAL