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Last Updated: March 29, 2024

CABOTEGRAVIR; RILPIVIRINE - Generic Drug Details


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What are the generic sources for cabotegravir; rilpivirine and what is the scope of patent protection?

Cabotegravir; rilpivirine is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabotegravir; rilpivirine has three hundred and ninety patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for CABOTEGRAVIR; RILPIVIRINE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CABOTEGRAVIR; RILPIVIRINE
Generic Entry Date for CABOTEGRAVIR; RILPIVIRINE*:
Constraining patent/regulatory exclusivity:
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 CABOTEGRAVIR; RILPIVIRINE

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 1/Phase 2
National Institute of Mental Health (NIMH)Phase 1/Phase 2
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 3

See all CABOTEGRAVIR; RILPIVIRINE clinical trials

US Patents and Regulatory Information for CABOTEGRAVIR; RILPIVIRINE

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 212888-002 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 212888-002 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 Y 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 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
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 CABOTEGRAVIR; RILPIVIRINE

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 CABOTEGRAVIR; RILPIVIRINE

Country Patent Number Title Estimated Expiration
Hungary 0401346 HIV-gátló pirimidinszármazékok, eljárás az előállításukra és ezeket tartalmazó gyógyszerkészítmények (HIV INHIBITING PYRIMIDINES DERIVATIVES, PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM) ⤷  Try a Trial
Mexico 2013003037 COMPOSICIONES FARMACEUTICAS. (PHARMACEUTICAL COMPOSITIONS.) ⤷  Try a Trial
Croatia P20120265 DERIVATI PIRIMIDINA KOJI INHIBIRAJU HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES) ⤷  Try a Trial
Eurasian Patent Organization 200970047 ВОДНЫЕ СУСПЕНЗИИ ТМС278 ⤷  Try a Trial
Cyprus 1124601 ⤷  Try a Trial
Taiwan 200817008 Aqueous suspensions of TMC278 ⤷  Try a Trial
Australia 2011302030 Pharmaceutical compositions ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CABOTEGRAVIR; RILPIVIRINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 C01419152/02 Switzerland ⤷  Try a Trial PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
1874117 14C0041 France ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
1874117 C300676 Netherlands ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
3808743 CR 2022 00035 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER RILPIVIRINHYDROCHLORID, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128
1419152 2012C/020 Belgium ⤷  Try a Trial PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
2465580 C02465580/01 Switzerland ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67740 08.10.2021
1419152 SPC/GB12/025 United Kingdom ⤷  Try a Trial PRODUCT NAME: A COMBINATION OF RILPIVIRINE, A N-OXIDE, A PHARMACEUTICALLY ACCEPTABLE ADDITION SALT INCLUDING THE HYDROCHLORIC ACID SALT, OR A QUATERNARY AMINE THEREOF, AND TENOFOVIR, IN PARTICULAR TENOFOVIR DISOPROXIL FUMARATE.; REGISTERED: UK EU/1/11/737/001 20111128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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