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Last Updated: March 28, 2024

~ Buy the CABENUVA KIT (cabotegravir; rilpivirine) Drug Profile, 2024 PDF Report in the Report Store ~

CABENUVA KIT Drug Patent Profile


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

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 ninety patent family members in fifty-one 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 three 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 Loss of Exclusivity (LOE) 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
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 3
ViiV HealthcarePhase 4

See all CABENUVA KIT clinical trials

US Patents and Regulatory Information for CABENUVA KIT

CABENUVA KIT is protected by five US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CABENUVA KIT is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG

Aqueous suspensions of TMC278
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG BY MONTHLY ADMINISTRATION OF RILPIVIRINE SUSPENSION AS PART OF COMBINATION THERAPY

HIV inhibiting pyrimidines derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG

(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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Try a Trial

NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 212888-001 Jan 21, 2021 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-002 Jan 21, 2021 ⤷  Try a Trial ⤷  Try a Trial
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 2013005907
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 10524
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13000715
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3547266
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0161280
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18279
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 4924
Estimated Expiration: ⤷  Try a Trial

Patent: 1390233
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31336
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5028
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 31385
Estimated Expiration: ⤷  Try a Trial

Patent: 14500849
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6193
Estimated Expiration: ⤷  Try a Trial

Patent: 13003037
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 520
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600350
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 222
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 16076
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1301766
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1938662
Estimated Expiration: ⤷  Try a Trial

Patent: 130116254
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 94557
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 77377
Estimated Expiration: ⤷  Try a Trial

Patent: 1223529
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 8250
Estimated Expiration: ⤷  Try a Trial

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
Croatia P20120265 DERIVATI PIRIMIDINA KOJI INHIBIRAJU HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES) ⤷  Try a Trial
South Korea 20160003889 HIV 통합효소 억제 활성을 가지는 다환식 카르바모일피리돈 유도체 (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY) ⤷  Try a Trial
Ukraine 97641 ВОДНА СУСПЕНЗІЯ 4-[[4-[[4-(2-ЦІАНОЕТЕНІЛ)-2,6-ДИМЕТИЛФЕНІЛ]АМІНО]-2-ПІРИМІДИНІЛ]АМІНО]БЕНЗОНІТРИЛУ (TMC278)[ВОДНАЯ СУСПЕНЗИЯ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА (ТМС278) (AQUEOUS SUSPENSIONS OF TMC278) ⤷  Try a Trial
Japan 2015044839 ピリミジンを含有するNNRTIとRTインヒビターとの組み合わせ物 (COMBINATION OF NNRTI CONTAINING PYRIMIDINE WITH RT INHIBITOR) ⤷  Try a Trial
Denmark 2040671 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CABENUVA KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1663240 1690061-5 Sweden ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1663240 CA 2015 00055 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
1663240 2015/053 Ireland ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE HYDROCHLORIDE SALT, TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE, AND EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152 122012000038 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
1663240 1590056-6 Sweden ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND TENOFOVIR DISOPROXIL, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/11/737 20111128
>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.