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. Nuplazid's patents have been open to challenges since 29 April, 2020. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7601740 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Apr, 2030
(4 years 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 |
| 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
(4 months from now) | Active |
| US7115634 | 4-aminopiperidine and their use as a medicine |
Oct, 2021
(3 years ago) |
Expired
|
| US9296694 | Azacyclic compounds |
Mar, 2021
(4 years ago) |
Expired
|
| US6756393 | Azacyclic compounds |
Mar, 2021
(4 years ago) |
Expired
|
| US6815458 | Azacyclic compounds |
Mar, 2021
(4 years ago) |
Expired
|
| US7858789 | Derivatives of 4-aminopiperidine and their use as a medicament |
Dec, 2020
(4 years ago) |
Expired
|
| US8110574 | Derivatives of 4-aminopiperidine and their use as a medicament |
Dec, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10849891 | Formulations of pimavanserin |
Aug, 2038
(13 years from now) | Active |
| US11452721 | Formulations of pimavanserin |
Aug, 2038
(13 years from now) | Active |
| US10449185 | Formulations of pimavanserin |
Aug, 2038
(13 years from now) | Active |
| US10646480 | Formulations of pimavanserin |
Aug, 2038
(13 years from now) | Active |
| US10953000 | Combination of pimavanserin and cytochrome P450 modulators |
Mar, 2037
(11 years from now) | Active |
| US10517860 | Combination of pimavanserin and cytochrome P450 modulators |
Mar, 2037
(11 years from now) | Active |
| US7659285 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Aug, 2026
(1 year, 3 months from now) | Active |
| US8618130 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US10028944 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US8921393 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US9566271 | Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases |
Jan, 2024
(1 year, 3 months ago) |
Expired
|
| US9765053 | Methods of treatment using selective 5-HT2A inverse agonists |
Jul, 2022
(2 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nuplazid's patents.
Latest Legal Activities on Nuplazid's Patents
Given below is the list of recent legal activities going on the following patents of Nuplazid.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US7601740 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10849891 |
| Email Notification Critical | 06 May, 2024 | US7601740 |
| Expire Patent Critical | 06 May, 2024 | US9296694 |
| Mail O.P. Petition Decision | 02 May, 2024 | US7601740 |
| Email Notification Critical | 02 May, 2024 | US7601740 |
| Mail-Petition Decision - Dismissed Critical | 30 Apr, 2024 | US7601740 |
| O.P. Petition Decision | 29 Apr, 2024 | US7601740 |
| Petition Decision - Dismissed Critical | 29 Apr, 2024 | US7601740 |
| Petition Entered | 15 Mar, 2024 | US7601740 |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
Approval Date:
Nuplazid was approved by FDA for market use on 28 June, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 10MG BASE | TABLET | Prescription | ORAL |
| EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |