CABENUVA KIT Drug Patent Profile

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 six patents protecting this drug.

This drug has three hundred and eighty-six patent family members in forty-nine 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

Summary for CABENUVA KIT

International Patents:	386
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CABENUVA KIT
DailyMed Link:	CABENUVA KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CABENUVA KIT

NDA:

212888

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

Sponsor	Phase
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)	Phase 3
ViiV Healthcare	Phase 4

See all CABENUVA KIT clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CABENUVA KIT

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 CABENUVA KIT

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

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

FDA Regulatory Exclusivity protecting CABENUVA KIT

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

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

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

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Mexico

Montenegro

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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
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)
Mexico	2007002595	CLORHIDRATO DE 4-[[4-[[4- (2-CIANOETENIL)-2, 6-DIMETILFENIL] AMINO]-2- PIRIMIDINIL] AMINO] BENZONITRILO. (HYDROCHLORIDE OF 4-[[4- [[4 -(2-CYANOETHENYL)-2, 6-DIMETHYLPHENYL] AMINO] -2-PYRIMIDINYL] AMINO] BENZONITRILE.)
Poland	368270	Pochodne pirymidyn hamujące wirusa HIV (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Lithuania	3284520
Taiwan	200524612	Combinations of a pyrimidine containing NNRTI with RT inhibitors
European Patent Office	2040671	SUSPENSIONS AQUEUSES DE TMC278 (AQUEOUS SUSPENSIONS OF TMC278)
Spain	2743531

Supplementary Protection Certificates for CABENUVA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1632232	SPC/GB17/008	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE.; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
1663240	1590055-8	Sweden		PRODUCT NAME: A COMBINATION OF RILPIVIRINE OR A PHARMACEUTICALLYACCEPTABLE SALT OF RILPIVIRINE, INICLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE, AND EMTRICITABINE; REG. NO/DATE: EU/1/11/737 20111128
1632232	PA2016043	Lithuania		PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1663240	122016000109	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
1663240	1690061-5	Sweden		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	93383	Luxembourg		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,EMTRICITABINE, ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE