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Last Updated: June 27, 2022

CABENUVA KIT Drug Patent Profile


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

Cabenuva Kit is a drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this drug.

This drug has three hundred and fifty patent family members in forty-seven countries.

The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. One supplier is listed for this compound. Additional details are available on the cabotegravir; rilpivirine profile page.

DrugPatentWatch® Generic Entry Outlook for Cabenuva Kit

Cabenuva Kit 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 September 15, 2031. This may change due to patent challenges or generic licensing.

There have been two 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 CABENUVA KIT
DrugPatentWatch® Estimated Generic Entry Opportunity Date for CABENUVA KIT
Generic Entry Date for CABENUVA KIT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

*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 CABENUVA KIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 4

See all CABENUVA KIT clinical trials

US Patents and Regulatory Information for CABENUVA KIT

CABENUVA KIT is protected by eight US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABENUVA KIT 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 CABENUVA KIT

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

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION IN ADULTS

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG

HIV inhibiting pyrimidines derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

(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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HIV INFECTION IN ADULTS

(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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 CABENUVA KIT

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS
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
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 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

Expired US Patents for CABENUVA KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 See Plans and Pricing See Plans and Pricing
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CABENUVA KIT

When does loss-of-exclusivity occur for CABENUVA KIT?

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

Australia

Patent: 11302030
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013005907
Estimated Expiration: See Plans and Pricing

Canada

Patent: 10524
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13000715
Estimated Expiration: See Plans and Pricing

China

Patent: 3547266
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0161280
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18279
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 16076
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4924
Estimated Expiration: See Plans and Pricing

Patent: 1390233
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 16076
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31336
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5028
Estimated Expiration: See Plans and Pricing

Japan

Patent: 31385
Estimated Expiration: See Plans and Pricing

Patent: 14500849
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 16076
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 6193
Estimated Expiration: See Plans and Pricing

Patent: 13003037
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 520
Estimated Expiration: See Plans and Pricing

Poland

Patent: 16076
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 16076
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600350
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 222
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 16076
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1301766
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1938662
Estimated Expiration: See Plans and Pricing

Patent: 130116254
Estimated Expiration: See Plans and Pricing

Spain

Patent: 94557
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 77377
Estimated Expiration: See Plans and Pricing

Patent: 1223529
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 8250
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 CABENUVA KIT around the world.

Country Patent Number Title Estimated Expiration
Australia 2006239177 Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity See Plans and Pricing
Norway 2016026 See Plans and Pricing
Spain 2384715 See Plans and Pricing
Argentina 046812 COMBINACIONES DE UN INHIBIDOR DE LA TRANSCRIPTASA INVERSA NO NUCLEOSIDO (NNRTI) CON CONTENIDO DE PIRIMIDINA CON INHIBIDORES DE LA TRANSCRIPTASA INVERSA See Plans and Pricing
Croatia P20161280 See Plans and Pricing
Mexico 2007013351 DERIVADO DE CARBAMOILPIRIDONA POLICICLICO QUE TIENE ACTIVIDAD INHIBIDORA DE LA INTEGRASA DE HIV. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY.) See Plans and Pricing
South Korea 101363875 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CABENUVA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 C300532 Netherlands See Plans and Pricing PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152 C 2012 016 Romania See Plans and Pricing PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128
1663240 2015/054 Ireland See Plans and Pricing PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152 2012C/020 Belgium See Plans and Pricing PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
1663240 92855 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE , TENOFOVIR, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL, ET L'EMTRICITABINE.
1632232 122016000111 Germany See Plans and Pricing PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1874117 202 50006-2014 Slovakia See Plans and Pricing PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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