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Last Updated: November 28, 2021

DrugPatentWatch Database Preview

INGREZZA Drug Patent Profile


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When do Ingrezza patents expire, and what generic alternatives are available?

Ingrezza is a drug marketed by Neurocrine and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-five 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

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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
Neurocrine BiosciencesPhase 2

See all INGREZZA clinical trials

Paragraph IV (Patent) Challenges for INGREZZA
Tradename Dosage Ingredient NDA Submissiondate
INGREZZA CAPSULE;ORAL valbenazine tosylate 209241

US Patents and Regulatory Information for 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2017075340 ⤷  Free Forever Trial
Australia 2017395702 ⤷  Free Forever Trial
Canada 3002074 ⤷  Free Forever Trial
Japan 2020505408 ⤷  Free Forever Trial
South Korea 20180075591 ⤷  Free Forever Trial
Taiwan 202021585 ⤷  Free Forever Trial
Taiwan 202114675 ⤷  Free Forever Trial
>Country >Patent Number >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.