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Last Updated: November 25, 2024

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INGREZZA Drug Patent Profile


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Which patents cover Ingrezza, and what generic alternatives are available?

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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Drug patent expirations by year for INGREZZA
Drug Prices for INGREZZA

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Recent Clinical Trials for INGREZZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Stephen RuedrichPhase 4
Neurocrine BiosciencesPhase 4
Michael BlochPhase 2

See all INGREZZA clinical trials

Pharmacology 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING HUNTINGTON'S CHOREA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Valbenazine salts and polymorphs thereof
Patent Number: ⤷  Sign Up
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: 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for the administration of certain VMAT2 inhibitors
Patent Number: ⤷  Sign Up
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)
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: 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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent Number: ⤷  Sign Up
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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

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

High dosage valbenazine formulation and compositions, methods, and kits related thereto
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


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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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
>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
Malaysia 195934 METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS ⤷  Sign Up
Malaysia 191077 METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017112857 ⤷  Sign Up
Israel 290686 שיטות למתן מעכבי vmat2 מסויימים למטופלים עם אי ספיקת כליות חמורה (Methods for the administration of certain vmat2 inhibitors to patients with severe renal impairment) ⤷  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.