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Last Updated: June 2, 2024

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VOCABRIA Drug Patent Profile


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When do Vocabria patents expire, and when can generic versions of Vocabria launch?

Vocabria is a drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and twenty-five patent family members in thirty-three countries.

The generic ingredient in VOCABRIA is cabotegravir sodium. One supplier is listed for this compound. Additional details are available on the cabotegravir sodium profile page.

DrugPatentWatch® Generic Entry Outlook for Vocabria

Vocabria will be eligible for patent challenges on January 21, 2025. 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 April 28, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VOCABRIA
International Patents:125
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 20
Patent Applications: 4
What excipients (inactive ingredients) are in VOCABRIA?VOCABRIA excipients list
DailyMed Link:VOCABRIA at DailyMed
Drug patent expirations by year for VOCABRIA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOCABRIA
Generic Entry Date for VOCABRIA*:
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Constraining patent/regulatory exclusivity:
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NDA:
212887
Dosage:
TABLET;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.

Pharmacology for VOCABRIA
Drug ClassHuman Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of ActionHIV Integrase Inhibitors
Organic Anion Transporter 1 Inhibitors
Organic Anion Transporter 3 Inhibitors
Anatomical Therapeutic Chemical (ATC) Classes for VOCABRIA
J05AJ Integrase inhibitors
J05A DIRECT ACTING ANTIVIRALS
J05 ANTIVIRALS FOR SYSTEMIC USE
J Antiinfectives for systemic use

US Patents and Regulatory Information for VOCABRIA

VOCABRIA is protected by three US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VOCABRIA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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 VOCABRIA

N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV-1 IN AN ADULT IN COMBINATION WITH RILPIVIRINE

(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG

FDA Regulatory Exclusivity protecting VOCABRIA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

REVISION TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 207966 ATLAS-2M
Exclusivity Expiration: ⤷  Sign Up

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Viiv Hlthcare VOCABRIA cabotegravir sodium TABLET;ORAL 212887-001 Jan 21, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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International Patents for VOCABRIA

When does loss-of-exclusivity occur for VOCABRIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 06239177
Estimated Expiration: ⤷  Sign Up

Patent: 06307101
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 16026
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0610030
Estimated Expiration: ⤷  Sign Up

Patent: 0617842
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Canada

Patent: 06282
Estimated Expiration: ⤷  Sign Up

Patent: 26956
Estimated Expiration: ⤷  Sign Up

China

Patent: 1212903
Estimated Expiration: ⤷  Sign Up

Patent: 1346376
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Cyprus

Patent: 15151
Estimated Expiration: ⤷  Sign Up

Patent: 16331
Estimated Expiration: ⤷  Sign Up

Patent: 20345
Estimated Expiration: ⤷  Sign Up

Patent: 22052
Estimated Expiration: ⤷  Sign Up

Patent: 24601
Estimated Expiration: ⤷  Sign Up

Patent: 14024
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 74117
Estimated Expiration: ⤷  Sign Up

Patent: 65580
Estimated Expiration: ⤷  Sign Up

Patent: 45206
Estimated Expiration: ⤷  Sign Up

Patent: 87225
Estimated Expiration: ⤷  Sign Up

Patent: 84520
Estimated Expiration: ⤷  Sign Up

Patent: 72281
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4162
Estimated Expiration: ⤷  Sign Up

Patent: 0702080
Estimated Expiration: ⤷  Sign Up

Patent: 0801144
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 52434
Estimated Expiration: ⤷  Sign Up

Patent: 74117
Estimated Expiration: ⤷  Sign Up

Patent: 50212
Estimated Expiration: ⤷  Sign Up

Patent: 65580
Estimated Expiration: ⤷  Sign Up

Patent: 27007
Estimated Expiration: ⤷  Sign Up

Patent: 45206
Estimated Expiration: ⤷  Sign Up

Patent: 87225
Estimated Expiration: ⤷  Sign Up

Patent: 87226
Estimated Expiration: ⤷  Sign Up

Patent: 84519
Estimated Expiration: ⤷  Sign Up

Patent: 84520
Estimated Expiration: ⤷  Sign Up

Patent: 72281
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 0210017
Estimated Expiration: ⤷  Sign Up

France

Patent: C0041
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Hong Kong

Patent: 07227
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Patent: 72282
Estimated Expiration: ⤷  Sign Up

Patent: 49742
Estimated Expiration: ⤷  Sign Up

Patent: 51191
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 37795
Estimated Expiration: ⤷  Sign Up

Patent: 44978
Estimated Expiration: ⤷  Sign Up

Patent: 56603
Estimated Expiration: ⤷  Sign Up

Patent: 400039
Estimated Expiration: ⤷  Sign Up

Patent: 100022
Estimated Expiration: ⤷  Sign Up

Patent: 100023
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Israel

Patent: 6555
Estimated Expiration: ⤷  Sign Up

Patent: 5206
Estimated Expiration: ⤷  Sign Up

Patent: 5207
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2006088173
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Patent: 2007049675
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Patent: 95353
Estimated Expiration: ⤷  Sign Up

Patent: 31689
Estimated Expiration: ⤷  Sign Up

Patent: 17257
Estimated Expiration: ⤷  Sign Up

Patent: 08540343
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Patent: 09079058
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Lithuania

Patent: 465580
Estimated Expiration: ⤷  Sign Up

Patent: 2021512
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Patent: 45206
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Patent: 84520
Estimated Expiration: ⤷  Sign Up

Patent: 72281
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0210
Estimated Expiration: ⤷  Sign Up

Patent: 446
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 2718
Estimated Expiration: ⤷  Sign Up

Patent: 2216
Estimated Expiration: ⤷  Sign Up

Patent: 07013351
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Patent: 08005137
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Morocco

Patent: 460
Estimated Expiration: ⤷  Sign Up

Patent: 879
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0676
Estimated Expiration: ⤷  Sign Up

Patent: 1109
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2339
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 9525
Estimated Expiration: ⤷  Sign Up

Patent: 0111
Estimated Expiration: ⤷  Sign Up

Patent: 17010
Estimated Expiration: ⤷  Sign Up

Patent: 21018
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Patent: 23042
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Patent: 075165
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Patent: 081892
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Patent: 161315
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Philippines

Patent: 007502373
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 74117
Estimated Expiration: ⤷  Sign Up

Patent: 65580
Estimated Expiration: ⤷  Sign Up

Patent: 45206
Estimated Expiration: ⤷  Sign Up

Patent: 84520
Estimated Expiration: ⤷  Sign Up

Patent: 72281
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 74117
Estimated Expiration: ⤷  Sign Up

Patent: 65580
Estimated Expiration: ⤷  Sign Up

Patent: 45206
Estimated Expiration: ⤷  Sign Up

Patent: 84520
Estimated Expiration: ⤷  Sign Up

Patent: 72281
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 74117
Estimated Expiration: ⤷  Sign Up

Patent: 65580
Estimated Expiration: ⤷  Sign Up

Patent: 45206
Estimated Expiration: ⤷  Sign Up

Patent: 87225
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Patent: 84520
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Patent: 72281
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South Africa

Patent: 0708970
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Patent: 0803423
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South Korea

Patent: 1363875
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Patent: 1504998
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Patent: 1580310
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Patent: 1848819
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Patent: 080009733
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Patent: 080064182
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Patent: 130133061
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Patent: 140097438
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Patent: 160003889
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Spain

Patent: 37268
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Patent: 46324
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Patent: 67197
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Patent: 69357
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Patent: 67868
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Patent: 43531
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Patent: 92304
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Patent: 06792
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Taiwan

Patent: 78931
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Patent: 0716635
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Patent: 0800988
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Ukraine

Patent: 568
Estimated Expiration: ⤷  Sign Up

Viet Nam

Patent: 404
Estimated Expiration: ⤷  Sign Up

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 VOCABRIA around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 200702080 ПОЛИЦИКЛИЧЕСКОЕ КАРБОМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ ⤷  Sign Up
European Patent Office 1874117 DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) ⤷  Sign Up
Norway 2023042 ⤷  Sign Up
Viet Nam 34404 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity ⤷  Sign Up
Canada 2626956 DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Supplementary Protection Certificates for VOCABRIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2465580 PA2021512,C2465580 Lithuania ⤷  Sign Up PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580 SPC/GB21/030 United Kingdom ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING CABOTEGRAVIR SODIUM.; REGISTERED: UK EU/1/20/1481 (NI) 20201221; UK PLGB 35728/0055-57 20201221
1874117 PA2014021,C1874117 Lithuania ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
1874117 C01874117/01 Switzerland ⤷  Sign Up PRODUCT NAME: DOLUTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC 63052 08.05.2014
2465580 301109 Netherlands ⤷  Sign Up PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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