Ingrezza is a drug owned by Neurocrine Biosciences Inc. It is protected by 22 US drug patents filed from 2017 to 2023 out of which none have expired yet. Ingrezza's patents have been open to challenges since 11 April, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 10, 2040. Details of Ingrezza'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. | |||
| US10906902 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| US10906903 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1,-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| US10919892 | Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
Dec, 2036
(12 years from now) | Active |
| US10851104 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(11 years from now) | Active |
| US10851103 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(11 years from now) | Active |
| US10844058 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(11 years from now) | Active |
| US10065952 | Valbenazine salts and polymorphs thereof |
Oct, 2036
(11 years from now) | Active |
| US8039627 | Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquinolin-2-ol compounds and methods relating thereto |
Apr, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10940141 | Methods for the administration of certain VMAT2 inhibitors |
Aug, 2040
(15 years from now) | Active |
| US11026931 | Methods for the administration of certain VMAT2 inhibitors |
Aug, 2039
(14 years from now) | Active |
| US11654142 | Methods for the administration of certain VMAT2 inhibitors |
Nov, 2038
(13 years from now) | Active |
| US11026939 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Sep, 2038
(13 years from now) | Active |
| US11311532 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Sep, 2038
(13 years from now) | Active |
| US10912771 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10952997 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US11439629 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10857137 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10857148 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10874648 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US10993941 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US11040029 | Methods for the administration of certain VMAT2 inhibitors |
Oct, 2037
(12 years from now) | Active |
| US8357697 | Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquinolin-2-ol compounds and methods relating thereto |
Nov, 2027
(2 years from now) | Active |
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 Ingrezza's patents.
Latest Legal Activities on Ingrezza's Patents
Given below is the list of recent legal activities going on the following patents of Ingrezza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Jul, 2024 | US10874648 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jun, 2024 | US10857148 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jun, 2024 | US10857137 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10851104 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jun, 2024 | US10851103 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 May, 2024 | US10844058 |
| Post Issue Communication - Certificate of Correction | 28 Dec, 2023 | US11654142 |
| Post Issue Communication - Certificate of Correction | 27 Jun, 2023 | US8357697 |
| Post Issue Communication - Certificate of Correction | 12 Jun, 2023 | US8357697 |
| Electronic Review Critical | 23 May, 2023 | US11654142 |
FDA has granted several exclusivities to Ingrezza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ingrezza, 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 Ingrezza.
Exclusivity Information
Ingrezza holds 3 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Ingrezza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 11, 2022 |
| New Indication(I-925) | Aug 18, 2026 |
| Orphan Drug Exclusivity(ODE-440) | Aug 18, 2030 |
US patents provide insights into the exclusivity only within the United States, but Ingrezza 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 Ingrezza's family patents as well as insights into ongoing legal events on those patents.
Ingrezza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ingrezza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 10, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ingrezza Generic API suppliers:
Valbenazine Tosylate is the generic name for the brand Ingrezza. 2 different companies have already filed for the generic of Ingrezza, with Zydus having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ingrezza's generic
How can I launch a generic of Ingrezza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ingrezza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ingrezza'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 Ingrezza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 80 mg | 12 Apr, 2021 | 4 | 10 Aug, 2040 | ||
| 60 mg | 14 Feb, 2022 | 1 | 10 Aug, 2040 |
Alternative Brands for Ingrezza
Ingrezza which is used for treating Huntington's chorea and tardive dyskinesia in patients without concomitant use of strong CYP3A4 inducers., has several other brand drugs in the same treatment category and using the same active ingredient (Valbenazine Tosylate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Teva |
| |||
| Teva Branded Pharm |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Valbenazine Tosylate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Neurocrine |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Valbenazine Tosylate, Ingrezza's active ingredient. Check the complete list of approved generic manufacturers for Ingrezza
About Ingrezza
Ingrezza is a drug owned by Neurocrine Biosciences Inc. It is used for treating Huntington's chorea and tardive dyskinesia in patients without concomitant use of strong CYP3A4 inducers. Ingrezza uses Valbenazine Tosylate as an active ingredient. Ingrezza was launched by Neurocrine in 2017.
Approval Date:
Ingrezza was approved by FDA for market use on 11 April, 2017.
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 Ingrezza is 11 April, 2017, its NCE-1 date is estimated to be 11 April, 2021.
Active Ingredient:
Ingrezza uses Valbenazine Tosylate as the active ingredient. Check out other Drugs and Companies using Valbenazine Tosylate ingredient
Treatment:
Ingrezza is used for treating Huntington's chorea and tardive dyskinesia in patients without concomitant use of strong CYP3A4 inducers.
Dosage:
Ingrezza is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 60MG BASE | CAPSULE | Prescription | ORAL |
| EQ 40MG BASE | CAPSULE | Prescription | ORAL |
| EQ 80MG BASE | CAPSULE | Prescription | ORAL |