cabenuva kit Drug Patent Profile

Which patents cover Cabenuva Kit, 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 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

Constraining patent/regulatory exclusivity:

11,224,597

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.

This potential generic entry date is based on patent 11,224,597.

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	12,178,815
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	8,410,103		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	7,125,879		Y	Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	11,224,597		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	10,927,129		Y	Y

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	6,838,464
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	8,080,551
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	6,838,464
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	7,125,879
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	8,080,551
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	7,125,879

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
World Intellectual Property Organization (WIPO)	2006024668
Eurasian Patent Organization	200700534	ФУМАРАТ 4-[[4-[[4-(2-ЦИАНОЭТЕНИЛ)-2,6-ДИМЕТИЛФЕНИЛ]АМИНО]-2-ПИРИМИДИНИЛ]АМИНО]БЕНЗОНИТРИЛА
Norway	20083770
Taiwan	I458483
Norway	2017065
European Patent Office	1950212	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITÉ D'INHIBITION SUR L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)
Australia	2001233979

Supplementary Protection Certificates for cabenuva kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	CR 2014 00032	Denmark		PRODUCT NAME: DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, HERUNDER DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892/001-002 20140121
1663240	375 5032-2016	Slovakia		PRODUCT NAME: RILPIVIRIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM/EMTRICITABIN/TENOFOVIR-ALAFENAMID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1112 20160623
1663240	92853	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 ET L'EMTRICITABINE
1419152	19/2012	Austria		PRODUCT NAME: RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBARE ADDITIONSSALZE VON RILPIVIRIN, ENSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 (MITTEILUNG) 20111130
1874117	1491036-8	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; FIRST MARKETING AUTHORIZATION NUMBER SE: EU/1/13/892, 2014-01-21;
1419152	162 5010-2012	Slovakia		PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
1419152	C 2012 016	Romania		PRODUCT NAME: COMBINATIE DE RILPIVIRINA SI TOATE FORMELE ECHIVALENTETERAPEUTIC ALE ACESTEIA CUM AR FI SARURILE DE ADITIE ALE RILPIVIRINEI ACCEPTABILE FARMACEUTIC, INCLUSIV SAREARILPIVIRINEI CU ACIDUL CLORHIDRIC, SI TENOFOVIR, IN PARTICULAR FUMARAT DE TENOFOVIRDISOPROXIL; NATIONAL AUTHORISATION NUMBER: EU/1/11/737/001, EU/1/11/737/002; DATE OF NATIONAL AUTHORISATION: 20111128; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/737/001, EU/1/11/737/002; DATE OF FIRST AUTHORISATION IN EEA: 20111128

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Cabenuva Kit

Last updated: July 28, 2025

Introduction

Cabenuva Kit, marketed by ViiV Healthcare, represents a substantial advancement in HIV treatment, offering a long-acting injectable regimen. Its approval in 2020 marked a new era for antiretroviral therapy (ART), emphasizing patient convenience and adherence. This article explores the market forces shaping Cabenuva's trajectory, analyzing competitive dynamics, payer landscape, technological evolution, and financial implications for stakeholders.

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Market Overview and Therapeutic Context

Cabenuva combines cabotegravir and rilpivirine, administered monthly via injection, representing a paradigm shift from daily oral pills to long-acting injectables. Its approval was driven by FDA's focus on improving adherence and reducing stigma associated with pill-taking [1].

The global HIV treatment market was valued at approximately USD 21 billion in 2022, with long-acting injectables expected to grow at a compounded annual growth rate (CAGR) of around 15% through 2030 [2]. Cabenuva’s share is projected to expand as expanding indications and increasing prescription volumes materialize.

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Market Drivers

1. Patient Adherence and Quality of Life

Long-acting injectables directly address adherence challenges inherent to daily regimens. Clinical trials demonstrate superior adherence and viral suppression rates [3]. Consequently, patient preference surveys favor injectable regimens, potentially increasing market penetration.

2. Clinician Adoption and Guidelines

Following approvals, HIV treatment guidelines in several regions are beginning to incorporate Cabenuva as a first-line option for eligible patients, especially those with adherence issues [4].

3. Regulatory Approvals and Expansions

Initial FDA approval was for viremic adults with suppressed viral loads. Ongoing clinical trials exploring broader populations, including treatment-naïve and adolescent patients, could considerably expand its market footprint.

4. Pricing and Reimbursement Landscape

Cabenuva’s premium pricing ($3,500-4,000 per dose in the U.S.) positions it as a high-margin product. Reimbursement policies, however, vary across regions, influencing access and sales volume. Payer acceptance is increasing due to anticipated long-term cost savings from improved adherence and reduced healthcare utilization [5].

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Market Challenges and Constraints

1. High Cost and Reimbursement Barriers

While pricing reflects innovation, high costs may limit access in resource-constrained settings. Reimbursement negotiations are complex, particularly outside developed markets.

2. Injection Logistics and Administration

Clinic-based administration requires infrastructure and scheduling, potentially limiting patient convenience compared to oral tablets. The necessity for trained personnel may impede rapid scale-up.

3. Patient Eligibility and Acceptability

Not all patients are suitable candidates—those with severe comorbidities or injection site sensitivities may be excluded. Some patients prefer oral therapy due to familiarity or needle aversion.

4. Emergence of Resistance and Long-term Safety Data

Extended safety data are needed to sustain clinician confidence, especially regarding resistance development and long-term tolerability.

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Competitive Landscape

Cabenuva faces competition from other long-acting modalities, such as:

• Apretude: Injectable cabotegravir for PrEP, indicating the potential for cross-indication sales.
• GSK’s Lenacapavir: An injectable capsid inhibitor under regulatory review for multidrug-resistant HIV.
• Oral Alternatives: Continual improvements in oral regimens (e.g., Biktarvy, Juluca) maintain competitive pressure, especially in settings with administrative barriers.

Emerging oral long-acting formulations and implantable devices could further challenge injectable therapies if they demonstrate comparable efficacy with easier administration.

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Financial Trajectory and Revenue Projections

1. Revenue Growth Outlook

ViiV Healthcare projects Cabenuva to become its flagship product, with revenues potentially exceeding USD 1.5 billion annually by 2027, assuming widespread adoption and expanded indications [6].

2. Pricing and Volume Dynamics

Given the premium pricing model, revenue growth hinges on market penetration. As drug approval expands and acceptance grows, volume sales could increase by 20-25% annually, supported by strategic medical education and payer negotiations.

3. Market Penetration Strategies

ViiV’s emphasis on patient-centric programs, real-world evidence generation, and expanding global access will dictate financial success. Tiered pricing strategies may facilitate entry into emerging markets.

4. Cost Considerations

Supply chain costs for injectables, including manufacturing and distribution, are substantial but decline over scale. Investment in clinical trials and real-world evidence gathering constitute significant expenditure but are critical for sustaining long-term revenue.

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Regulatory and Policy Influences

Regulatory pathways and supplemental indications significantly influence the financial trajectory. Expansion into pediatric and treatment-naïve populations could exponentially increase revenue streams. Conversely, reimbursement restrictions or delays could temper growth.

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Global Market Expansion and Access

While North America and Europe represent significant markets, access remains limited in low- and middle-income countries due to cost and infrastructure constraints. Initiatives like Gilead's PEPFAR collaborations aim to improve access, which would, over time, contribute to revenue diversification.

Future Outlook

The future of Cabenuva will depend on technological innovations, market acceptance, and health policy evolution. As data accumulates on long-term safety and efficacy, adoption is expected to rise, especially in populations with adherence challenges. The integration into comprehensive HIV care models and broader healthcare systems remains pivotal.

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Key Takeaways

• Cabenuva is poised for robust growth within the expanding long-acting HIV treatment market driven by adherence benefits and evolving guidelines.
• High pricing necessitates strategic payer negotiations and broadening indications to sustain revenue trajectories.
• Competitive pressures from emerging therapies and technological innovations could influence market share.
• Expansion into new patient populations and countries, backed by supportive policies, will be critical to maximizing financial potential.
• Effective adoption hinges on overcoming logistical, infrastructural, and reimbursement barriers, particularly outside developed economies.

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FAQs

1. What factors are most influential in the market adoption of Cabenuva Kit?
Patient adherence, clinician acceptance, reimbursement policies, and regulatory approvals primarily drive adoption. Infrastructure for clinic-based injections and patient preference also significantly influence uptake.

2. How does Cabenuva compare to oral HIV therapies in terms of cost-effectiveness?
While upfront costs are higher, long-term savings from reduced healthcare utilization and improved adherence can render Cabenuva cost-effective, especially for patients with adherence issues.

3. What are the main hurdles in expanding Cabenuva’s availability globally?
Cost, healthcare infrastructure, regulatory approvals, and clinician familiarity limit expansion. Addressing these requires tailored pricing, capacity building, and regulatory harmonization.

4. Will the trajectory of Cabenuva's revenues be affected by emerging long-acting or implantable therapies?
Yes. As alternative long-acting or implantable options enter the market, competition will increase, possibly impacting market share and profitability unless Cabenuva continues to differentiate through efficacy, safety, and convenience.

5. How significant is the role of clinical trials in shaping the future market for Cabenuva?
Critical. Ongoing trials exploring new indications, populations, and formulations influence regulatory approvals, clinician confidence, and ultimately, revenue potential.

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References

1. U.S. Food and Drug Administration (2020). FDA Approves ViiV Healthcare’s Cabenuva for HIV Treatment.
2. GlobalData. HIV Market Report 2022.
3. Swindells S, et al. Lancet HIV. 2021;8(5):e308–e317.
4. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents. 2022.
5. IMS Health. Long-acting HIV Therapies Economic Impact Study. 2022.
6. ViiV Healthcare Investor Presentations. 2022.

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Conclusion

Cabenuva’s long-acting injectable formulation offers a transformational opportunity within the HIV treatment market, promising increased adherence and improved patient outcomes. Its financial success hinges on strategic market expansion, reimbursement negotiations, and overcoming logistical challenges. Anchored by ongoing clinical research and evolving treatment guidelines, Cabenuva is positioned for substantial growth, provided it navigates the competitive landscape and global access hurdles effectively.