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 two NDAs. There are twenty-two patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and twelve 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.
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Summary for INGREZZA
| International Patents: | 212 |
| US Patents: | 22 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 40 |
| Clinical Trials: | 7 |
| Patent Applications: | 162 |
| 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 |
|---|---|
| Stephen Ruedrich | Phase 4 |
| Neurocrine Biosciences | Phase 4 |
| Michael Bloch | Phase 2 |
Pharmacology for INGREZZA
| Drug Class | Vesicular Monoamine Transporter 2 Inhibitor |
| Mechanism of Action | Vesicular Monoamine Transporter 2 Inhibitors |
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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Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷ Sign Up
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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Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent Number: ⤷ Sign Up
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
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA
High dosage valbenazine formulation and compositions, methods, and kits related thereto
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Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
| 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 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Neurocrine | INGREZZA | valbenazine tosylate | CAPSULE;ORAL | 209241-001 | Apr 11, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Neurocrine | INGREZZA SPRINKLE | valbenazine tosylate | CAPSULE;ORAL | 218390-002 | Apr 30, 2024 | 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
Patent: FORMULACIÓN Y COMPOSICIONES DE VALBENAZINA DE ALTA DOSIS, MÉTODOS Y EQUIPOS RELACIONADOS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 18335259
Patent: High dosage valbenazine formulation and compositions, methods, and kits related thereto
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020005373
Patent: formulação de valbenazina em alta dosagem e composições, métodos e kits relacionados com valbenazina
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 76000
Patent: FORMULATION DE VALBENAZINE A DOSAGE ELEVE ET COMPOSITIONS, PROCEDES ET KITS ASSOCIES (HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS, AND KITS RELATED THERETO)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1372567
Patent: 高剂量的缬苯那嗪制剂和与其相关的组合物、方法和试剂盒 (High dosage valbenazine formulation and compositions, methods, and kits related thereto)
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2090809
Patent: ВЫСОКОДОЗОВЫЙ СОСТАВ ВАЛБЕНАЗИНА И КОМПОЗИЦИИ, СПОСОБЫ И НАБОРЫ, СВЯЗАННЫЕ С НИМ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 84333
Patent: FORMULATION DE VALBENAZINE À DOSAGE ÉLEVÉ ET COMPOSITIONS, PROCÉDÉS ET KITS ASSOCIÉS (HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS, AND KITS RELATED THERETO)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3300
Patent: פורמולציית ולבנאזין במינון גבוה ותכשירים, שיטות וערכות קשורות להן (High dosage valbenazine formulation and compositions, methods, and kits related thereto)
Estimated Expiration: ⤷ Sign Up
Patent: 1770
Patent: פורמולציית ולבנאזין במינון גבוה ותכשירים, שיטות וערכות קשורות להן (High dosage valbenazine formulation and compositions, methods, and kits related thereto)
Estimated Expiration: ⤷ Sign Up
Patent: 9802
Patent: פורמולציית ולבנאזין במינון גבוה ותכשירים, שיטות וערכות קשורות להן (High dosage valbenazine formulation and compositions, methods, and kits related thereto)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 50006
Estimated Expiration: ⤷ Sign Up
Patent: 20534305
Patent: 高投与量バルベナジン製剤ならびにそれに関連する組成物、方法およびキット
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20002841
Patent: FORMULACION DE VALBENAZINA DE ALTA DOSIS Y COMPOSICIONES, METODOS Y KITS RELACIONADOS CON LA MISMA. (HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS, AND KITS RELATED THERETO.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 175
Patent: FORMULATION DE VALBENAZINE À DOSAGE ÉLEVÉ ET COMPOSITIONS, PROCÉDÉS ET KITS ASSOCIÉS
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 1919622
Patent: High dosage VALBENAZINE formulation and compositions, methods, and kits related thereto
Estimated Expiration: ⤷ Sign Up
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 | 2022544711 | 特定のＶＭＡＴ２阻害剤を重度腎障害の患者に投与するための方法 | ⤷ Sign Up |
| Australia | 2017395700 | Methods for the administration of certain VMAT2 inhibitors | ⤷ Sign Up |
| Serbia | 65154 | SOLI VALBENAZIN DIHIDROHLORIDA I NJIHOVI POLIMORFI (VALBENAZINE DIHYDROCHLORIDE SALTS AND POLYMORPHS THEREOF) | ⤷ Sign Up |
| Canada | 3149033 | PROCEDES D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2 A DES PATIENTS PRESENTANT UNE INSUFFISANCE RENALE GRAVE (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) | ⤷ Sign Up |
| Croatia | P20210469 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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