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 one NDA. There are nineteen patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-three patent family members in thirty 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 four 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.

Indicators of Generic Entry

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Summary for INGREZZA

International Patents:	143
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	6
Patent Applications:	164
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

Drug patent expirations by year for INGREZZA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for INGREZZA

Generic Entry Date for INGREZZA^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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

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-one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INGREZZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.
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

Valbenazine salts and polymorphs thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING VALBENAZINE 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-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

High dosage valbenazine formulation and compositions, methods, and kits related thereto
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

Methods for the administration of certain VMAT2 inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting INGREZZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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Glossary

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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	209241-003	Apr 23, 2021		RX	Yes	No	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing		Y		See Plans and Pricing
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 18335259
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2020005373
Estimated Expiration: See Plans and Pricing

Canada

Patent: 76000
Estimated Expiration: See Plans and Pricing

China

Patent: 1372567
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2090809
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 84333
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3300
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20534305
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 175
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1919622
Estimated Expiration: See Plans and Pricing

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.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3368534		See Plans and Pricing
Japan	2010509366		See Plans and Pricing
World Intellectual Property Organization (WIPO)	2018140095		See Plans and Pricing
Israel	284874		See Plans and Pricing
Poland	3368534		See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration