CABENUVA KIT Drug Patent Profile

Which patents cover Cabenuva Kit, and what generic alternatives are available?

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

This drug has four hundred and eighty-five patent family members in fifty-three 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 was eligible for patent challenges on January 21, 2025.

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:	485
US Patents:	9
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

US Patents and Regulatory Information for CABENUVA KIT

CABENUVA KIT is protected by nine 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.

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
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
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	212888-001	Jan 21, 2021		RX	Yes	Yes			Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	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	212888-002	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
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	212888-001	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
Austria	472537
South Korea	20130127515	COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS
Luxembourg	92446
Cyprus	2021016
Japan	2005041878	2,4-DI(HETERO-)ARYLAMINO(-OXY)-5-SUBSTITUTED PYRIMIDINE AS ANTINEOPLASTIC AGENT
Denmark	1278735

Supplementary Protection Certificates for CABENUVA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	132016000024751	Italy		PRODUCT NAME: ASSOCIAZIONE DI RILPIVIRINA E OGNI SUA FORMA TERAPEUTICAMENTE EQUIVALENTE PROTETTA DAL BREVETTO DI BASE, COME SALI DI ADDIZIONE FARMACEUTICAMENTE ACCETTABILI DI RILPIVIRINA, COMPRESO IL SUO SALE CLORIDRATO E EMTRICITABINA(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1419152	C01419152/01	Switzerland		PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
1663240	122016000108	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, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1632232	CA 2016 00066	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1419152	CA 2012 00021	Denmark
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

Market Dynamics and Financial Trajectory for CABENUVA KIT

Last updated: December 27, 2025

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Executive Summary

CABENUVA KIT, a long-acting injectable regimen comprising cabotegravir and rilpivirine for HIV-1 treatment, stands at the forefront of advancements in antiretroviral therapy (ART). Approved by the FDA in January 2021, this regimen addresses patient compliance challenges by reducing dosing frequency from daily oral pills to monthly or bimonthly injections. This analysis explores the market forces shaping CABENUVA KIT’s trajectory, including competitive landscape, regulatory environment, patient demand, reimbursement policies, and projected revenues over the coming decade.

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Market Overview

Parameter	Data / Insights
Approval Date	January 2021 (FDA) [1]
Therapeutic Area	HIV-1/AIDS treatment
Product Type	Long-acting injectable regimen (CABENUVA)
Manufacturer	ViiV Healthcare (GSK subsidiary)
Current Indications	Treatment-experienced adults with suppressed viral load
Pricing (US)	Approx. $4,000–$4,300 per month (varies by insurer and pharmacy benefit) [2]

Market Drivers

• Patient Adherence and Convenience: Non-daily dosing improves compliance, particularly among populations with adherence challenges, including young adults and marginalized groups.
• Shift Toward Long-Acting Therapies: The success of CABENUVA catalyzes development and adoption of long-acting formulations across HIV treatment and other chronic diseases.
• Regulatory Endorsement: approval by FDA, EMA, and other regulators enhances confidence and international adoption.
• Increased Awareness and Physician Advocacy: medical community's push for innovative delivery methods fuels uptake.

Market Restraints

• Injection Site Reactions: Common adverse events potentially limiting wider acceptance.
• Cost and Reimbursement Challenges: High price point demands substantial payer engagement.
• Operational Logistics: Need for specialized administration settings could restrict access, especially in resource-limited regions.
• Patient Preference: Some patients prefer oral regimens over injections for personal or cultural reasons.

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Competitive Landscape

Competitors	Key Features	Market Status	Strengths	Weaknesses
CABENUVA (ViiV)	Monthly or bimonthly injections	Market leader	First long-acting injectable approved in USA	Cost, injection site reactions
GSK’s RAL-INT (Raltegravir)	Long-acting injectable under trial	Phase 3 trials	Unique mechanism	Limited data on long-term safety
Johnson & Johnson (Janssen)	Long-acting cabotegravir + rilpivirine	Under development	Potential pipeline edge	Pending regulatory review
Oral regimens (e.g., Biktarvy, Descovy)	Daily oral pills	Established market	Lower cost, known safety profile	Adherence challenges

Financial Trajectory and Revenue Projections

Market Penetration Estimates (2023-2033)

Year	Estimated Global Sales (US$ Millions)	Assumptions / Rationale
2023	$350	Initial launch, limited geographic penetration
2025	$1,200	Broader adoption in North America & Europe; expanding indications
2027	$2,500	Competitive positioning, increased penetration in HIV-specialist clinics
2030	$4,000	Global market reach, inclusion in treatment guidelines
2033	$5,500	Mature market with potential for expanded indications

CAGR (2023-2033): Approx. 30%

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Regulatory and Policy Environment

• FDA Approval (US): January 2021; recognizes CABENUVA as a first-in-class long-acting injectable for treatment-experienced adults with suppressed viral loads [1].
• EMA Approval: Received in the UK and EU in late 2021; ongoing approval processes in other territories.
• Reimbursement Policies: ViiV has negotiated with numerous payers, leveraging cost-effectiveness models to justify premium pricing.
• Global Access Initiatives: GSK's partnerships to improve access in low- and middle-income countries, such as through Gavi, facilitate broader adoption.

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Comparison with Alternative Long-Acting Regimens

Parameter	CABENUVA	RAL-INT (in development)	Injectable CAB-LA (Pre-Exposure Prophylaxis)
Indication	Treatment of HIV-1	HIV treatment	Pre-exposure prophylaxis (PrEP)
Approval Status	Approved (2021)	Phase 3	Approved in some markets for PrEP
Dosing Interval	Monthly / Bimonthly	Under trial	Monthly
Market Penetration	Leading	Emerging	Growing, disease-specific

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Questions-Style Analysis

What are the key factors influencing the adoption of CABENUVA KIT?
Adoption is driven by patient adherence improvements, physician endorsement, regulatory approvals, favorable reimbursement policies, and operational infrastructure.

How does pricing impact market potential?
High cost necessitates strategic negotiations with payers; cost-effectiveness analyses demonstrating reduced long-term health costs support premium pricing, but access remains a challenge.

What role do competing therapies and pipeline candidates play?
Competitors like oral regimens and emerging injectables influence market share, pressuring pricing dynamics and compelling ViiV to innovate further.

How are logistical challenges being addressed?
ViiV and healthcare providers are developing specialized clinics and training programs to facilitate injection delivery, crucial for scaling adoption.

What is the potential global reach for CABENUVA KIT?
While primarily launched in high-income markets, partnerships and subsidies aim to expand access in LMICs, aligning with WHO's HIV targets.

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Key Takeaways

• Market Leadership: CABENUVA KIT pioneered the long-acting injectable HIV treatment segment, signifying a paradigm shift from daily pills to monthly injections.
• Revenue Potential: Estimated to reach US$5.5 billion globally by 2033, driven by expanding indications and geographic penetration.
• Market Challenges: High costs, logistical hurdles, and patient acceptance influence growth trajectories.
• Strategic Opportunities: Continued pipeline development, value-based pricing, and global access initiatives will determine long-term market dominance.
• Regulatory and Policy Influence: Ongoing approvals and reimbursement policies will significantly shape the adoption landscape.

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References

[1] FDA. (2021). FDA Approves Cabenuva for HIV Treatment.
[2] GoodRx. (2022). Cabenuva Cost and Pricing Data.
[3] GSK. (2021). Cabenuva: First Long-Acting Injectable for HIV Treatment.
[4] IQVIA. (2022). Global Trends in HIV Treatment Market.

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This comprehensive assessment underscores the promising yet complex market trajectory for CABENUVA KIT, highlighting that its success hinges on strategic positioning, regulatory support, patient acceptance, and affordability.