Cabotegravir; rilpivirine - Generic Drug Details

What are the generic drug sources for cabotegravir; rilpivirine and what is the scope of freedom to operate?

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-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for cabotegravir; rilpivirine

International Patents:	392
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	20
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabotegravir; rilpivirine
DailyMed Link:	cabotegravir; rilpivirine at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for cabotegravir; rilpivirine

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

Sponsor	Phase
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

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir; rilpivirine

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AJ	Integrase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes			Y	Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes

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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021

International Patents for cabotegravir; rilpivirine

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	011036	ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА (FUMARATE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6-DIMETHYLPHENYL]AMINO]-2-PYRIMIDINYL]AMINO]BENZONITRILE)
Luxembourg	92008
Lithuania	2040671
Canada	2452217	DERIVES DE PYRIMIDINES INHIBITEURS DE VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Brazil	PI0211909	compostos derivados de pirimidina que inibem o hiv, processos para as suas preparações e respectiva composição farmacêutica
European Patent Office	2298761	DERIVES D'UNE PYRIMIDINE EN TANT QU'INHIBITEUR DU VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES)

Supplementary Protection Certificates for cabotegravir; rilpivirine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	1290017-1	Sweden		PRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
3808743	122022000051	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE EIN PHARMAZEUTISCH AKZEPTABLES ADDITIONSSALZ VON RILPIVIRIN, EINSCHLIESSLICH DES SALZSAEURESALZES VON RILPIVIRIN, UND EMTRICITABIN.; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	C20150041 00168	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
1632232	PA2016042	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
3808743	PA2022515	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU EKVIVALENTISKOS JO FORMOS APSAUGOTOS PAGRINDINIU PATENTU, TOKIOS KAIP FARMACINIU POZIURIU PRIIMTINOS PRIDETINES RILPIVIRINO DRUSKOS, ISKAITANT RILPIVIRINO HIDROCHLORIDO RUGSTIES DRUSKA, IR EMTRICITABINO DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128