INGREZZA Drug Patent Profile
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Which patents cover Ingrezza, and when can generic versions of Ingrezza launch?
Ingrezza is a drug marketed by Neurocrine and is included in one NDA. There are twenty patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and eighty-five patent family members in thirty-two countries.
The generic ingredient in INGREZZA is valbenazine tosylate. One supplier is listed for this compound. Additional details are available on the valbenazine tosylate profile page.
DrugPatentWatch® Generic Entry Outlook for Ingrezza
Ingrezza was eligible for patent challenges on April 11, 2021.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 18, 2038. This may change due to patent challenges or generic licensing.
There have been seven 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.
There are two tentative approvals for the generic drug (valbenazine tosylate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for INGREZZA
International Patents: | 185 |
US Patents: | 20 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 34 |
Clinical Trials: | 6 |
Patent Applications: | 192 |
Drug Prices: | Drug price information for INGREZZA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for INGREZZA |
What excipients (inactive ingredients) are in INGREZZA? | INGREZZA excipients list |
DailyMed Link: | INGREZZA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INGREZZA
Generic Entry Date for INGREZZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 INGREZZA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Michael Bloch | Phase 2 |
The Orthopedic Foundation | Phase 4 |
Neurocrine Biosciences | Phase 2 |
Pharmacology for INGREZZA
Drug Class | Vesicular Monoamine Transporter 2 Inhibitor |
Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for INGREZZA
Paragraph IV (Patent) Challenges for INGREZZA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
INGREZZA | Capsules | valbenazine tosylate | 60 mg | 209241 | 1 | 2022-02-14 |
INGREZZA | Capsules | valbenazine tosylate | 40 mg and 80 mg | 209241 | 4 | 2021-04-12 |
US Patents and Regulatory Information for INGREZZA
INGREZZA is protected by twenty-two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of INGREZZA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a 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.
Patents protecting INGREZZA
Valbenazine salts and polymorphs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ADMINISTERING VALBENAZINE WHILE AVOIDING CONCOMITANT USE OF A STRONG CYP3A4 INDUCER
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1,-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING TARDIVE DYSKINESIA WHILE AVOIDING CONCOMITANT USE OF A STRONG CYP3A4 INDUCER
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquin- olin-2-ol compounds and methods relating thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquin- olin-2-ol compounds and methods relating thereto
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
FDA Regulatory Exclusivity protecting INGREZZA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
International Patents for INGREZZA
When does loss-of-exclusivity occur for INGREZZA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2819
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 18335259
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2020005373
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 76000
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1372567
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2090809
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 84333
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 3300
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 50006
Estimated Expiration: ⤷ Try a Trial
Patent: 20534305
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 20002841
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 175
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 1919622
Estimated Expiration: ⤷ Try a 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.
See the table below for additional patents covering INGREZZA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Philippines | 12019501732 | METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS | ⤷ Try a Trial |
China | 111836543 | 施用某些VMAT2抑制剂的方法 (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) | ⤷ Try a Trial |
China | 108925135 | 制备(S)-(2R,3R,11bR)-3-异丁基-9,10-二甲氧基-2,3,4,6,7,11b-六氢-1H-吡啶并[2,1-a]异喹啉-2-基2-氨基-3-甲基丁酸酯二(4-甲基苯磺酸盐)的合成方法 (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]lSOQUINOLIN-2-YL 2-AMINO-3-METHYLBUTANOATE DI(4-METHYLBENZENESULFONATE)) | ⤷ Try a Trial |
Canada | 3051829 | METHODES D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2 (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) | ⤷ Try a Trial |
Jordan | P20200336 | طرق إعطاء مثبطات VMAT2 معينة (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2018140094 | ⤷ Try a Trial | |
Mexico | 2019008855 | METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DEL TRANSPORTADOR DE MONAMINA VESICULAR 2 (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |