INGREZZA Drug Patent Profile

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 patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-five patent family members in thirty-two 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^® Generic Entry Outlook for Ingrezza

Ingrezza was eligible for patent challenges on April 11, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 18, 2038. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (valbenazine tosylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INGREZZA

International Patents:	185
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	6
Patent Applications:	192
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

See drug prices for INGREZZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INGREZZA

NDA:

209241

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

See all INGREZZA clinical trials

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

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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 twenty-two US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INGREZZA

FDA Regulatory Exclusivity protecting INGREZZA

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	209241-003	Apr 23, 2021		RX	Yes	No			Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No			Y	Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes			Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No

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

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

Morocco

Taiwan

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
Philippines	12019501732	METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS
China	111836543	施用某些VMAT2抑制剂的方法 (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)
China	108925135	制备(S)-(2R,3R,11bR)-3-异丁基-9,10-二甲氧基-2,3,4,6,7,11b-六氢-1H-吡啶并[2,1-a]异喹啉-2-基2-氨基-3-甲基丁酸酯二(4-甲基苯磺酸盐)的合成方法 (SYNTHETIC METHODS FOR PREPARATION OF (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMETHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRIDO[2,1,-A]lSOQUINOLIN-2-YL 2-AMINO-3-METHYLBUTANOATE DI(4-METHYLBENZENESULFONATE))
Canada	3051829	METHODES D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2 (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)
Jordan	P20200336	طرق إعطاء مثبطات VMAT2 معينة (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)
World Intellectual Property Organization (WIPO)	2018140094
Mexico	2019008855	METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DEL TRANSPORTADOR DE MONAMINA VESICULAR 2 (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.)