INGREZZA Drug Patent Profile
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When do Ingrezza patents expire, and what generic alternatives are available?
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 eight 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: | 208 |
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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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Valbenazine salts and polymorphs thereof
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
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Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Valbenazine salts and polymorphs thereof
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Valbenazine salts and polymorphs thereof
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Valbenazine salts and polymorphs thereof
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: METHOD OF ADMINISTERING VALBENAZINE WHILE AVOIDING CONCOMITANT USE OF A STRONG CYP3A4 INDUCER
Methods for the administration of certain VMAT2 inhibitors
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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)
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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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Methods for the administration of certain VMAT2 inhibitors
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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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)
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Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
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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
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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
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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
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Patented Use: TREATMENT OF TARDIVE DYSKINESIA
FDA Regulatory Exclusivity protecting INGREZZA
FOR TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULTS WITH CHOREA ASSOCIATED WITH HUNTINGTON’S DISEASE
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Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-002 | Oct 4, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-002 | Oct 4, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-003 | Apr 23, 2021 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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: ⤷ Sign Up
Australia
Patent: 18335259
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Brazil
Patent: 2020005373
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Canada
Patent: 76000
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China
Patent: 1372567
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Eurasian Patent Organization
Patent: 2090809
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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
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Patent: 20534305
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Mexico
Patent: 20002841
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Morocco
Patent: 175
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Taiwan
Patent: 1919622
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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 |
---|---|---|---|
Japan | 7107950 | ⤷ Sign Up | |
Lithuania | 3394057 | ⤷ Sign Up | |
Mexico | 2022007141 | METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DE PROTEINA TRANSPORTADORA TRANSPORTADOR DE MONOAMINA VESICULAR (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |