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 twenty-five patent family members in thirty-five 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: | 225 |
US Patents: | 22 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 40 |
Clinical Trials: | 7 |
Patent Applications: | 163 |
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 |
---|---|
Neurocrine Biosciences | Phase 4 |
Stephen Ruedrich | 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.
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: ⤷ Try for Free
Australia
Patent: 18335259
Patent: High dosage valbenazine formulation and compositions, methods, and kits related thereto
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2020005373
Patent: formulação de valbenazina em alta dosagem e composições, métodos e kits relacionados com valbenazina
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Eurasian Patent Organization
Patent: 2090809
Patent: ВЫСОКОДОЗОВЫЙ СОСТАВ ВАЛБЕНАЗИНА И КОМПОЗИЦИИ, СПОСОБЫ И НАБОРЫ, СВЯЗАННЫЕ С НИМ
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Japan
Patent: 50006
Estimated Expiration: ⤷ Try for Free
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: ⤷ Try for Free
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: ⤷ Try for Free
Morocco
Patent: 175
Patent: FORMULATION DE VALBENAZINE À DOSAGE ÉLEVÉ ET COMPOSITIONS, PROCÉDÉS ET KITS ASSOCIÉS
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 1919622
Patent: High dosage VALBENAZINE formulation and compositions, methods, and kits related thereto
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Malaysia | 193767 | VALBENAZINE SALTS AND POLYMORPHS THEREOF | ⤷ Try for Free |
Lithuania | 3875459 | ⤷ Try for Free | |
Mexico | 2022000559 | METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DE VMAT2 A PACIENTES CON INSUFICIENCIA RENAL GRAVE. (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS TO PATIENTS WITH SEVERE RENAL IMPAIRMENT.) | ⤷ Try for Free |
Spain | 2857085 | ⤷ Try for Free | |
Canada | 2668689 | COMPOSES 3-ISOBUTYL-9, 10-DIMETHOXY-1,3,4,6,7,11B-HEXAHYDRO-2H-PYRIDO[2,1-A] ISOQUINOLIN-2-OL SUBSTITUES ET PROCEDES ASSOCIES (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) | ⤷ Try for Free |
Croatia | P20240304 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for INGREZZA (Valbenazine)
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