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Last Updated: May 26, 2022

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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Drug patent expirations by year for INGREZZA
Drug Prices for INGREZZA

See drug prices for INGREZZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for INGREZZA
Generic Entry Date for INGREZZA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Michael BlochPhase 2
The Orthopedic FoundationPhase 4
Neurocrine BiosciencesPhase 2

See all INGREZZA clinical trials

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

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

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

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: 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

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: 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

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

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
Patented Use: TREATMENT OF TARDIVE DYSKINESIA

FDA Regulatory Exclusivity protecting INGREZZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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.

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

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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.