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Last Updated: March 30, 2020

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INGREZZA Drug 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 three patents protecting this drug.

This drug has thirty-four patent family members in twenty countries.

The generic ingredient in INGREZZA is valbenazine tosylate. Additional details are available on the valbenazine tosylate profile page.

US ANDA Litigation and Generic Entry Outlook for Ingrezza

Ingrezza will be eligible for patent challenges on April 11, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 28, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for INGREZZA
International Patents:34
US Patents:3
Applicants:1
NDAs:1
Bulk Api Vendors: 21
Patent Applications: 16
Drug Prices: Drug price information for INGREZZA
DailyMed Link:INGREZZA at DailyMed
Drug patent expirations by year for INGREZZA
Drug Prices for INGREZZA

See drug prices for INGREZZA

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.

Synonyms for INGREZZA
(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl L-valinate
(2R,3R,11bR)-9,10-Dimethoxy-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H- benzo(a)quinolizin-2-yl L-valinate
(S)-2-amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester
[(2R,3R,11bR)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]isoquinolin-2-yl] (2S)-2-amino-3-methylbutanoate
1025504-45-3
54K37P50KH
AS-35294
CHEMBL2364639
CS-5908
D10675
DB11915
EX-A2002
GEJDGVNQKABXKG-CFKGEZKQSA-N
GTPL8694
HY-16771
L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo(a)quinolizin-2-yl ester
L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester
L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl ester;L-Valine, (2R,3R,11bR)-1,3,4,6,7,11b-hexahydro-9,10-dimethoxy-3-(2-methylpropyl)-2H-benzo[a]quinolizin-2-yl es
NBI 98854
NBI-98854;NBI98854;NBI 98854
Q27089118
SB17456
SCHEMBL15932979
UNII-54K37P50KH
Valbenazine
Valbenazine (USAN/INN)
Valbenazine [USAN:INN]
Valbenazine pound NBI-98854 pound(c)
ZINC43195697

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 209241-001 Apr 11, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
Baxter
McKesson
Medtronic
AstraZeneca

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.