CABOTEGRAVIR - Generic Drug Details

What are the generic drug sources for cabotegravir and what is the scope of freedom to operate?

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:	64
What excipients (inactive ingredients) are in CABOTEGRAVIR?	CABOTEGRAVIR excipients list
DailyMed Link:	CABOTEGRAVIR at DailyMed

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

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
Massachusetts General Hospital	PHASE4
Fenway Community Health	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	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes			Y	Y

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
Slovenia	1874117
European Patent Office	3187225	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
South Korea	20080009733	POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY
Ukraine	96568	ПОЛІЦИКЛІЧНЕ ПОХІДНЕ КАРБАМОЇЛПІРИДОНУ ЯК ІНГІБОР ВІЛ-ІНТЕГРАЗИ[ПОЛИЦИКЛИЧЕСКОЕ ПРОИЗВОДНОЕ КАРБАМОИЛПИРИДОНА КАК ИНГИБИТОР ВИЧ-ИНТЕГРАЗЫ (POLYCYCLIC CARBAMOYL PYRIDONE DERIVATIVE AS HIV-INTEGRASE INHIBITOR)

Supplementary Protection Certificates for CABOTEGRAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	14C0041	France		PRODUCT NAME: DOLUTEGRAVIR ET SES SELS OU SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES,NOTAMMENT LE DOLUTEGRAVIR SODIQUE.; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
2465580	CA 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/DATE: EU/1/20/1481 20201221
2465580	C20210013 00397	Estonia		PRODUCT NAME: KABOTEGRAVIIR;REG NO/DATE: EU/1/120/1481; 21.12.2020
1874117	CA 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 20140116

Market Dynamics and Financial Trajectory for Cabotegravir: A Strategic Overview

Last updated: July 31, 2025

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Introduction

Cabotegravir, an investigational HIV integrase strand transfer inhibitor (INSTI), has garnered considerable attention within the pharmaceutical landscape owing to its promising profile as a long-acting injectable therapy. Developed by pharmaceutical giants such as ViiV Healthcare—a joint venture between GlaxoSmithKline and Pfizer—cabotegravir stands at the forefront of innovative HIV treatment paradigms. Its unique delivery mechanism and potential to reduce pill burden could significantly influence market dynamics and reshape the financial trajectory of HIV therapeutics over the next decade.

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Market Landscape and Dynamics

Epidemiological Drivers

The global HIV/AIDS epidemic remains a pervasive health challenge, with an estimated 38 million people living with HIV as of 2022 [1]. Sub-Saharan Africa bears the highest burden, but disparities persist worldwide. The continued need for effective, accessible, and patient-friendly antiretroviral therapies (ART) drives innovation in drug delivery methods, including long-acting injectables such as cabotegravir.

Competitive Positioning

Cabotegravir's distinguishing feature is its potential for monthly or bi-monthly injectable administration, targeting adherence challenges endemic to daily oral regimens. It is primarily positioned as:

• Treatment-naïve: with ongoing clinical trials assessing its efficacy and safety as a first-line therapy.
• Pre-exposure prophylaxis (PrEP): with the LATTE-2 trial demonstrating promising results [2].

Currently, cabotegravir is approved in select regions for HIV PrEP, notably in the United States and the European Union, indicating regulatory acceptance of its clinical benefits. Its competitors include existing oral regimens and emerging long-acting agents like lenacapavir.

Regulatory Milestones and Approvals

The FDA approved cabotegravir for HIV PrEP in December 2021 under the brand name Apretude, marking its commercial entry into the prophylactic market [3]. Other regulatory agencies have followed suit, enhancing its market visibility. These approvals are pivotal, as they catalyze adoption and stimulate demand within high-risk populations.

Market Penetration and Adoption Barriers

Despite regulatory progress, several factors influence market penetration:

• Cost considerations: Long-acting injectables often incur higher upfront costs than oral therapies, posing barriers in resource-limited settings.
• Healthcare infrastructure: Administering injections requires clinic visits and trained personnel, which could hamper widespread adoption in low-income regions.
• Patient acceptance: While appealing for adherence, injection-related side effects and needle phobia may limit some patients' acceptance.

Pricing Outlook

Pricing strategies for cabotegravir hinge on production costs, competitive pricing of existing therapies, and payer negotiations. Initial prices are expected to be premium given the innovative format and clinical advantages, but market competition and patent expirations could drive prices downward over time.

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Financial Trajectory

Revenue Projections

The financial outlook for cabotegravir hinges largely on its approved indications, global acceptance, and market share penetration.

• HIV PrEP segment: Since its FDA approval in 2021, estimates suggest PrEP markets could reach $1.5 billion to $2 billion annually in the U.S. alone by the mid-2020s, driven by increased awareness and dosing convenience [4].
• Treatment segment: While still under clinical evaluation, successful demonstration of efficacy as a first-line treatment could open additional revenue streams, potentially doubling or tripling initial projections.

Key factors influencing revenue include:

• Pricing strategies that balance margin preservation with market penetration.
• Physician and patient acceptance based on clinical data, safety profiles, and real-world effectiveness.
• Expansion into emerging markets with tailored pricing and distribution strategies.

Investment and R&D Impact

ViiV Healthcare’s substantial R&D investments (~$2 billion annually in HIV pipeline) underpin continued clinical trials, regulatory submissions, and potential line extensions of cabotegravir. These investments will be critical in achieving approvals for additional indications, optimizing formulations, and enhancing global access.

Patent Landscape and Market Exclusivity

Patent protections—granted until approximately 2030—afford ViiV exclusive rights, enabling pricing leverage and securing revenue streams. Post-expiration, biosimilar and generic entrants could challenge profitability, emphasizing the importance of patent extensions and lifecycle management.

Market Risks and Challenges

• Emergence of competitors: Novel long-acting agents, such as lenacapavir from Gilead Sciences, could compress market share.
• Regulatory hurdles: Delays or rejections in key markets could impede revenue growth.
• Pricing pressures: Cost containment policies, especially in publicly funded health systems, threaten premium pricing models.

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Strategic Opportunities and Future Outlook

Pipeline Expansion

Upcoming clinical trials aim to validate cabotegravir's efficacy as first-line therapy, dual-therapy regimens, and in various demographic segments including adolescents. Successful outcomes could unlock additional market segments and boost sales.

Global Access Initiatives

Collaborations with global health agencies and local manufacturers could facilitate access in low- and middle-income countries, expanding market share and fulfilling corporate social responsibility goals, thereby stabilizing long-term revenues.

Digital and Telehealth Integration

Innovative delivery models, telehealth consultations, and digital adherence support could enhance patient engagement, especially in remote or underserved populations, fostering sustained demand.

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Key Takeaways

• Market potential remains significant, driven by the global HIV burden and demand for patient-centric therapies.
• Regulatory approvals for PrEP position cabotegravir as a key player in HIV prevention, with revenues potentially reaching billions annually.
• Clinically, its long-acting, infrequently administered format may dramatically improve adherence and outcomes.
• Pricing and reimbursement strategies, along with effects of patent protections, will heavily influence the financial trajectory.
• Competition and market evolution demand continuous innovation, pipeline expansion, and strategic collaborations to sustain growth.

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FAQs

1. What are the main advantages of cabotegravir over traditional HIV therapies?
Cabotegravir offers long-acting injectable dosing—monthly or bi-monthly—reducing pill burden, enhancing adherence, and potentially improving clinical outcomes compared to daily oral regimens.

2. What challenges could impede cabotegravir’s market growth?
Barriers include high costs, infrastructure requirements for administration, patient hesitancy regarding injections, regulatory hurdles, and emerging competitors.

3. How does patent protection influence cabotegravir's revenue potential?
Patent protections provide exclusivity until approximately 2030, enabling premium pricing and market control, but patent cliffs post-expiry could introduce biosimilar competition, affecting revenues.

4. What are the prospects for cabotegravir in emerging markets?
While market potential exists, access constraints such as affordability, healthcare infrastructure, and regulatory approval pose challenges. Strategic partnerships and tiered pricing could expand reach.

5. How might future clinical developments impact cabotegravir’s financial outlook?
Successful trials for new indications or formulations can diversify revenue streams, increase market share, and improve patient outcomes, positively influencing long-term profitability.

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References

[1] UNAIDS. Global HIV & AIDS statistics—Fact sheet 2022.
[2] Markowitz, M., et al. (2017). "Long-acting injectable cabotegravir in HIV prevention." The New England Journal of Medicine.
[3] U.S. Food & Drug Administration. (2021). FDA approves first injectable drug for HIV Prevention.
[4] Research and Markets. (2022). HIV Pre-Exposure Prophylaxis (PrEP) Market Analysis & Trends.

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