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 eight patents protecting this drug.

This drug has two hundred and eighty-eight patent family members in forty-six 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:	288
US Patents:	8
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 eight US patents and one FDA Regulatory Exclusivity.

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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes			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	212888-001	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 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
Israel	192132	שימוש ב- tcm-278 לייצור תרופה לטיפול ארוך טווח בנגיף תסמונת הכשל החיסוני הנרכש (Use of tcm278 for the manufacture of a medicament for long term treatment of hiv)
South Korea	20060090658	COMBINATIONS OF A PYRIMIDINE CONTAINING NNRTI WITH RT INHIBITORS
Taiwan	I365744

Supplementary Protection Certificates for CABENUVA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	C20150040 00167	Estonia		PRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
3808743	C20220027 00378	Estonia		PRODUCT NAME: EMTRITSITABIIN/ RILPIVIRIIN;REG NO/DATE: EU/1/11/737 28.11.2011
1874117	PA2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116

Market Dynamics and Financial Trajectory for Cabenuva Kit

Last updated: February 20, 2026

What Is the Current Market Position of Cabenuva Kit?

Cabenuva, produced by ViiV Healthcare, is an injectable combination therapy for HIV-1 treatment. Approved by the FDA in January 2021, it combines cabotegravir and rilpivirine. Its unique monthly or bimonthly dosing positions it as a significant innovation in antiretroviral therapy (ART). As of 2023, Cabenuva commands a significant market share among long-acting HIV treatments.

Market Size and Growth Potential

In 2022, the global HIV treatment market was valued at approximately $28 billion [1]. Long-acting formulations accounted for roughly 15% of the market. With increasing demand for less frequent dosing options, projections estimate the long-acting segment will grow at a compound annual growth rate (CAGR) of 10-12% through 2030 [2].

Cabenuva's estimated sales reached $1.2 billion in 2022, representing a 35% increase from the prior year, driven by expanding approvals and clinical adoption. Its market penetration remains concentrated in North America and Europe but is expanding into Asia-Pacific markets.

Competitive Landscape

Primary competitors include:

• Apretude (cabotegravir injections for pre-exposure prophylaxis) by ViiV Healthcare.
• Long-acting rilpivirine formulations under development.
• Oral regimens such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Dovato (dolutegravir/lamivudine).

Cabenuva's differentiation lies in its monthly or bimonthly injection schedule, reducing pill burden. However, concerns about injection site reactions and the need for healthcare infrastructure for administration limit rapid global adoption.

Financial Trajectory and Revenue Drivers

Revenue Drivers

• Expanded approvals: FDA expanded Cabenuva's use in 2022 from maintenance therapy to initial treatment in certain populations.
• Market penetration: Increasing adoption in clinics and specialty centers.
• Pricing strategy: Gross price per dose approximates $4,200, with annual therapy costing around $50,000 [3]. Payers are negotiating rebates and discounts.
• Reimbursement policies: Insurance coverage and government programs influence sales volume.

Cost and Investment Patterns

ViiV Healthcare invests heavily in clinical trials, with over $750 million allocated to long-acting HIV therapy development in 2021–2022 [4]. Marketing expenses are focused on physician education and patient awareness campaigns.

Forecasts

Analysts forecast Cabenuva sales will reach between $2 billion and $3 billion by 2025, contingent on market acceptance and competitive pressures. Steady growth is expected as approval expands into more countries and as long-acting formulations become standard in HIV management.

Regulatory and Policy Influences

Global regulatory environments influence the trajectory:

• United States: FDA approved for both maintenance and initial therapy.
• European Union: Approved under conditional marketing authorization; expansion of indications anticipated.
• Emerging markets: Limited regulatory pathways may delay widespread access.

Policy shifts toward community-based treatment and reduced clinic visits can accelerate adoption of long-acting injectable therapies.

Market Challenges

• Injection site reactions: Reported in 15-20% of patients, affecting tolerability.
• Administration logistics: Requires healthcare settings for injections; limits self-administration.
• Pricing and reimbursement: High costs create barriers in low-resource settings.
• Competition: Development of oral long-acting formulations might threaten market share.

Key Takeaways

• Cabenuva is a pioneering long-acting HIV treatment with increasing sales and market share.
• The global HIV treatment market is shifting toward injectable regimens, fueling growth.
• Sales projections range from $2 billion to $3 billion by 2025, driven by expanding indications and approvals.
• Market entry barriers include drug tolerability concerns, infrastructure needs, and high costs.
• Regulatory and reimbursement policies significantly influence market development.

FAQs

1. What factors could limit Cabenuva's market expansion?
Injection site reactions, administration logistics, high treatment costs, and emerging oral long-acting formulations.

2. How does Cabenuva compare financially to oral HIV therapies?
Annual therapy costs are approximately $50,000, higher than many oral regimens, affecting affordability and access in low-income regions.

3. Are there indications for Cabenuva beyond maintenance therapy?
Yes, FDA approved its use for initial therapy in certain patient populations as of 2022.

4. What are the primary regional markets for Cabenuva?
North America and Europe currently dominate, with emerging markets in Asia-Pacific showing potential growth.

5. How does the competitive landscape influence Cabenuva's sales?
Competitors developing similar long-acting or oral formulations may erode market share, especially if they offer better tolerability or lower costs.

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References

1. Statista. (2023). Global HIV treatment market size. https://statista.com
2. MarketsandMarkets. (2023). Long-acting HIV treatment market forecast. https://marketsandmarkets.com
3. ViiV Healthcare. (2023). Cabenuva pricing and reimbursement. https://viiv.com
4. Company filings and investor reports. (2022). ViiV Healthcare R&D expenditure.