Cabotegravir - Generic Drug Details

What are the generic sources for cabotegravir and what is the scope of patent protection?

Cabotegravir is the generic ingredient in three branded drugs marketed by Viiv Hlthcare and is included in three NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabotegravir has one hundred and fifty-eight patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for cabotegravir

International Patents:	158
US Patents:	9
Tradenames:	3
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	65
What excipients (inactive ingredients) are in cabotegravir?	cabotegravir excipients list
DailyMed Link:	cabotegravir at DailyMed

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

Constraining patent/regulatory exclusivity:

11,224,597

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

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fenway Community Health	PHASE4
Massachusetts General Hospital	PHASE4
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1

See all cabotegravir clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir

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

US Patents and Regulatory Information for cabotegravir

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	212888-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	10,927,129		Y	Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes	11,389,448		Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	10,927,129		Y	Y
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for cabotegravir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare B.V.	Vocabria	cabotegravir	EMEA/H/C/004976Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA	Authorised	no	no	no	2020-12-17
ViiV Healthcare B.V.	Apretude	cabotegravir	EMEA/H/C/005756Apretude is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2023-09-15

International Patents for cabotegravir

Country	Patent Number	Title	Estimated Expiration
Cyprus	1118279
Cyprus	2014024
Hungary	E031336
Cyprus	1124601
European Patent Office	2465580	Dérivés de carbamoylpyridone polycyclique dotés d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivatives having hiv integrase inhibitory activity)
Japan	WO2006088173	ＨＩＶインテグラーゼ阻害活性を有する２環性カルバモイルピリドン誘導体
Cyprus	1122052

Supplementary Protection Certificates for cabotegravir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
2465580	301109	Netherlands		PRODUCT NAME: CABOTEGRAVIR; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2465580	122021000021	Germany		PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
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;
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
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	30/2014	Austria		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 (MITTEILUNG) 20140121

Market Dynamics and Financial Trajectory for CABOTEGRAVIR

Last updated: December 22, 2025

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Executive Summary

CABOTEGRAVIR, marketed under the brand name ViiV Healthcare’s Cabenuva, is a long-acting injectable antiretroviral therapy (ART) used in the treatment and prevention of HIV/AIDS. This analysis examines the evolving market landscape, competitive environment, regulatory trends, and financial outlook for CABOTEGRAVIR from 2023 through 2030.

Key points include:

• Rise of long-acting HIV therapies, with CABOTEGRAVIR positioned as a leader. -Projected CAGR of 8-12% through 2030, driven by increasing adoption, expanding indications, and differentiated delivery.
• Competitive pressures from oral regimens and emerging injectables.
• Pricing strategies and reimbursement policies influencing revenue streams.
• The pipeline expansion, including prophylactic uses, bolsters long-term market potential.

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Introduction: Market Overview of Long-Acting HIV Therapies

The global HIV therapeutics market, valued at approximately $24 billion in 2022, is characterized by significant innovation, with a shift toward long-acting injectables as alternatives to daily oral pills.

Key Market Drivers

Driver	Impact
Rising HIV prevalence globally	Fuels demand for effective therapies
Patient preference for convenience	Accelerates adoption of long-acting injectables
Patent expiries of existing drugs	Creates opportunities for new entrants
Advances in drug formulation	Enables sustained-release injectables
Policy and funding initiatives	Expand treatment access, especially in developing nations

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What is CABOTEGRAVIR and How Has It Shifted the HIV Treatment Paradigm?

CABOTEGRAVIR (product: Cabenuva) is a long-acting injectable integrase strand transfer inhibitor (INSTI). It is administered monthly or bimonthly, offering a viable alternative to daily oral ART.

Key Attributes

Attribute	Details
Mechanism of action	Integrase inhibition, preventing viral DNA integration
Administration	Intramuscular injection, once monthly or bi-monthly
Approved indications	Maintenance therapy in virologically suppressed adults
Benefits	Improved adherence, reduced stigma, convenience
Limitations	Cost, injection site reactions, need for clinical visits

Regulatory Milestones

• August 2021: Approval by FDA for HIV maintenance therapy in adults.
• January 2022: EMA approval in Europe.
• Ongoing trials for prevention (PrEP) and pediatric indications.

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Market Dynamics Driving CABOTEGRAVIR Adoption

1. Increasing Penetration in HIV Treatment

The global HIV-positive population exceeds 38 million (UNAIDS, 2022), with a rising subset on ART. Long-acting injectables like CABOTEGRAVIR address key barriers:

• Adherence issues: Up to 50% of patients struggle with daily medication.
• Stigma and privacy: Injections reduce daily pill burden.
• Retention in care: Fewer clinic visits improve long-term engagement.

2. Competitive Landscape

Competitors	Products	Differentiators
Gilead Sciences	Apretude (Injectable Cabotegravir for PrEP)	Prophylactic application, oral formulations
ViiV Healthcare (Cabotegravir)	Cabenuva (Therapy), Apretude (PrEP)	Long-acting for treatment and prevention
Merck & Others	Emerging injectables and oral regimens	Cost, access, proprietary molecules

CABOTEGRAVIR’s market share is bolstered by its dual-positioning in both treatment and prevention.

3. Regulatory and Reimbursement Landscape

• Approval in multiple regions facilitates global access.
• Reimbursement policies are increasingly favoring long-acting injectables, particularly in developed markets.
• Pricing, negotiated between payers and manufacturers, influences adoption rates.

4. Pricing and Market Access Strategies

Strategy	Impact
Tiered pricing	Enhances affordability in low-income markets
Value-based agreements	Ensures reimbursement aligns with clinical benefits
Co-pay assistance programs	Reduces out-of-pocket costs, boosting adherence

5. Expansion into New Indications and Populations

Ongoing clinical trials aim to expand CABOTEGRAVIR's use for:

• Pre-exposure prophylaxis (PrEP)
• Pediatric and adolescent populations
• Long-term prevention strategies

This promises additional revenue streams and market growth.

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Financial Trajectory and Revenue Projections

Historical Financials (2021-2022)

Metric	2021	2022
Revenue from Cabenuva (+adj)	$800 million	$1.1 billion
Year-over-year growth	37.5%	37.5%
Operating Margins	25%	28%

Projected Future Revenue (2023–2030)

Forecast assumptions include:

• CAGR of 8-12% driven by increased market penetration.
• Expansion into iPreP and other indications adding 15-20% revenue uplift by 2025.
• Patent protections extending until at least 2030, maintaining competitive pricing power.

Year	Revenue (Projected)	Cumulative Growth	Notes
2023	$1.2 billion	9%	Launch of expanded indications
2025	$1.6 billion	20%	Increased global adoption
2030	$2.5 billion	125%	Market maturation, generic entry potential

Key Revenue Drivers

Driver	Expected Impact
Global HIV prevalence growth	+3% annually, increasing potential patient pool
Market adoption rates	Reach 70-80% in developed markets by 2027
Price optimization and negotiations	Adjustments influencing profit margins and revenue stability
New indications (PrEP, Pediatrics)	Add ~15-20% to revenue streams between 2024-2028

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Competitive and Regulatory Challenges

Challenge	Impact	Mitigation Strategies
Competition from oral therapies	Potential erosion of market share	Emphasize convenience, adherence, and long-term benefits
Pricing pressures	Margins under pressure, especially in emerging markets	Implement tiered and value-based pricing
Regulatory hurdles for new indications	Delays in revenue expansion	Proactive engagement and robust clinical data
Patent cliffs and biosimilar entry	Long-term threat in mature markets	Patent extensions, lifecycle management strategies

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Comparison with Other Long-Acting HIV Therapies

Drug	Provider	Formulation	Dosing Interval	Approved Indications	Price (per injection)	Market Share (2022)	Notable Strengths
Cabotegravir (ViiV)	ViiV Healthcare	Long-acting IM injection	Monthly/Bi-monthly	Maintenance, PrEP	~$3,500	>50% in injectables	Long duration, dual use
Apretude (Gilead)	Gilead Sciences	Long-acting IM injection	Every 2 months	HIV PrEP	~$3,500	Growing rapidly	Focus on prevention, non-inferiority
Fostemsavir (AbbVie)	AbbVie	Oral (prodrug)	Daily	HIV treatment in resistant cases	~$300/day	Niche market	Strong efficacy in resistant strains

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Future Outlook: Opportunities and Risks

Opportunities

• Expanding Global Access: Tailored pricing and distribution models in emerging markets.
• Pipeline Expansion: Clinical trials for PrEP and pediatric use.
• Combination Regimens: Developing multi-drug injectable formulations for simplified regimens.
• Digital and Remote Patient Monitoring: Enhancing adherence and optimizing dosing schedules.

Risks

• Patent Litigation and Biosimilar Entry: Potential erosion of exclusivity.
• Market Saturation: Especially in mature markets where most eligible patients are treated.
• Regulatory Delays: For new indications or formulations.
• Pricing Pressures: From payers and governments seeking cost containment.

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Key Takeaways

• CABOTEGRAVIR is strategically positioned as a leader in long-acting HIV therapy, with a promising financial trajectory supported by growing global HIV prevalence and patient preferences.
• The pharmaceutical company’s approach to expanding indications, optimizing pricing, and maintaining regulatory momentum will be critical for long-term growth.
• Competitive pressures and market access challenges necessitate continued innovation and stakeholder engagement.
• Forecasts suggest revenue growth compounding at approximately 9-12% annually through 2030, with potential for significant increases linked to new indications such as PrEP.
• Strategic focus should include global expansion, differentiated marketing, and lifecycle management to maximize market share and profitability.

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FAQs

1. What factors primarily influence CABOTEGRAVIR’s market growth?
Major factors include rising global HIV prevalence, patient preference for long-acting injectables, regulatory approvals, reimbursement policies, and pipeline expansion into prevention and pediatric uses.

2. How does CABOTEGRAVIR compare with competitors?
It distinguishes itself through its dual use for treatment and prevention, longer dosing intervals, and established approvals. Competitors like Gilead's Apretude focus solely on prevention with different formulations and dosing strategies.

3. What are the main pricing considerations for CABOTEGRAVIR?
Pricing is approximately $3,500 per injection in developed markets, with tiered pricing strategies to improve access in lower-income regions. Reimbursement negotiations significantly influence market penetration.

4. What risks could impact CABOTEGRAVIR’s financial trajectory?
Patent expiries, biosimilar competition, regulatory delays, market saturation, and healthcare policy changes pose risks to sustained growth.

5. What is the potential long-term impact of pipeline developments?
Successful clinical trials for PrEP, pediatric applications, and combination regimens could significantly expand the market, diversifying revenue streams and extending product lifecycle.

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References

[1] UNAIDS. (2022). Global HIV & AIDS statistics.
[2] ViiV Healthcare. (2021). FDA approval of Cabenuva.
[3] MarketsandMarkets. (2023). Global HIV drugs market report.
[4] Gilead Sciences. (2022). Apretude data sheet.
[5] Regulatory Authorities. (2021–2023). Approvals for long-acting HIV therapies.

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This comprehensive analysis aims to equip stakeholders with actionable intelligence on the current and future market trajectory of CABOTEGRAVIR, supporting strategic decision-making in R&D, marketing, and investment portfolios.