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-two patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and seven patent family members in thirty-three 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® Litigation and Generic Entry Outlook for Ingrezza
A generic version of INGREZZA was approved as valbenazine tosylate by LUPIN LTD on April 5th, 2024.
Summary for INGREZZA
International Patents: | 207 |
US Patents: | 22 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 6 |
Patent Applications: | 176 |
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 |
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 thirty-three US patents and two FDA Regulatory Exclusivities.
Patents protecting INGREZZA
Valbenazine salts and polymorphs thereof
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Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
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Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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: A METHOD OF TREATING HUNTINGTON'S CHOREA
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: A METHOD OF TREATING HUNTINGTON'S CHOREA
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: A METHOD OF TREATING HUNTINGTON'S CHOREA
Methods for the administration of certain VMAT2 inhibitors
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Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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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
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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)
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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: A METHOD OF TREATING HUNTINGTON'S CHOREA
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
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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: A METHOD OF TREATING HUNTINGTON'S CHOREA
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
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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: A METHOD OF TREATING HUNTINGTON'S CHOREA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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: A METHOD OF TREATING HUNTINGTON'S CHOREA
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
FOR TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE
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
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Israel
Patent: 3300
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Patent: 1770
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Patent: 9802
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Japan
Patent: 50006
Estimated Expiration: ⤷ Try a Trial
Patent: 20534305
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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 |
---|---|---|---|
South Korea | 20180075591 | 발베나진 염 및 그의 다형체 | ⤷ Try a Trial |
Slovenia | 3368534 | ⤷ Try a Trial | |
Philippines | 12019501734 | METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS | ⤷ Try a Trial |
Malaysia | 195934 | METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS | ⤷ Try a Trial |
Japan | 2022174343 | 特定のVMAT2インヒビターを投与するための方法 | ⤷ Try a Trial |
South Korea | 20230170135 | 특정 VMAT2 억제제의 투여 방법 (VMAT2 METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2008058261 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |