Cabotegravir sodium - Generic Drug Details

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

Cabotegravir sodium is the generic ingredient in one branded drug marketed by Viiv Hlthcare and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cabotegravir sodium has one hundred and twenty-six patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for cabotegravir sodium

International Patents:	126
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	1
What excipients (inactive ingredients) are in cabotegravir sodium?	cabotegravir sodium excipients list
DailyMed Link:	cabotegravir sodium at DailyMed

Recent Clinical Trials for cabotegravir sodium

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

Sponsor	Phase
ViiV Healthcare	Phase 1

See all cabotegravir sodium clinical trials

Pharmacology for cabotegravir sodium

Drug Class	Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir sodium

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

US Patents and Regulatory Information for cabotegravir sodium

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
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	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	8,410,103		Y	Y

Expired US Patents for cabotegravir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	VOCABRIA	cabotegravir sodium	TABLET;ORAL	212887-001	Jan 21, 2021	10,927,129

International Patents for cabotegravir sodium

Country	Patent Number	Title	Estimated Expiration
Mexico	2008005137	DERIVADO DE CARBAMOILPIRIDONA POLICICLICA QUE TIENE ACTIVIDAD INHIBIDORA EN VIH INTEGRASA. (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE.)
European Patent Office	2527007	Dérivé de carbamoylpyridone polycyclique doté d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity)
Eurasian Patent Organization	014162	ПОЛИЦИКЛИЧЕСКОЕ КАРБАМОИЛПИРИДОНОВОЕ ПРОИЗВОДНОЕ, ОБЛАДАЮЩЕЕ ИНГИБИТОРНОЙ АКТИВНОСТЬЮ В ОТНОШЕНИИ ИНТЕГРАЗЫ ВИЧ (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Netherlands	301109
Slovenia	3372281

Supplementary Protection Certificates for cabotegravir sodium

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	2190020-4	Sweden		PRODUCT NAME: CABOTEGRAVIR OR A PHAMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1481 20201221
1874117	PA2014021	Lithuania		PRODUCT NAME: DOLUTEGRAVIRUM NATRICUM; REGISTRATION NO/DATE: EU/1/13/892/001, 2014 01 16 EU/1/13/892/002 20140116
1874117	C201430032	Spain		PRODUCT NAME: DOLUTEGRAVIR O UNA SAL O SOLVATO DEL MISMO FARMACEUTICAMENTE ACEPTABLE, INCLUIDA LA SAL SODICA DE DOLUTEGRAVIR.; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2465580	C 2021 017	Romania		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF NATIONAL AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217
1874117	202 50006-2014	Slovakia		PRODUCT NAME: SODNA SOL DOLUTEGRAVIRU; REGISTRATION NO/DATE: EU/1/13/892/001 - EU/1/13/892/002 20140121

Market Dynamics and Financial Trajectory for Cabotegravir Sodium

Last updated: March 5, 2026

What Are the Key Market Drivers for Cabotegravir Sodium?

Cabotegravir sodium is an integrase strand transfer inhibitor (INSTI) developed primarily for HIV treatment and prevention. Its market growth hinges on several factors:

• Efficacy and approval status: Regulatory approval by agencies such as FDA (2019) and EMA (2020) for long-acting injectable HIV therapies drive demand.
• Shift toward long-acting therapies: Preference for less frequent dosing (monthly injections) enhances patient adherence versus daily oral regimens.
• Underserved populations: Increasing HIV prevalence in sub-Saharan Africa, North America, and Europe expands accessible market segments.
• Primary indications: Treatment of HIV (both as a part of combination therapy) and pre-exposure prophylaxis (PrEP) positions it for sustained utilization.

What Is the Current Market Size and Forecast?

The global market for HIV therapeutics exceeded USD 30 billion in 2022. Analysts project compound annual growth rates (CAGR) at approximately 4%-6% through 2030, driven by innovative drugs such as cabotegravir.

Market Segmentation

Segment	2023 Market Share	Growth Drivers
Long-acting injectable HIV	35%	Enhanced adherence, fewer doses
Oral antiretrovirals	55%	Established safety profiles
Pre-exposure prophylaxis	10%	Prevention focus, expanding access

Long-acting injectables are set to dominate the market over the next five years, accounting for a projected 55% share by 2028([1]).

What Are the Key Competitive Players?

• ViiV Healthcare: Market leader with Cabotegravir formulations (e.g., Vocabria, Cabenuva).
• Gilead Sciences: Developing competing therapies and generic options.
• Merck & Co.: Partnering on long-acting formulations targeting HIV and potential other indications.
• Minoryx Therapeutics: Focused on rare disease pipelines but exploring similar modalities.

ViiV Healthcare maintains dominant market share due to early approval, extensive commercialization, and ongoing clinical trials.

How Do Regulatory and Policy Environments Affect Financial Trajectory?

The therapeutic approval process, patent landscape, and reimbursement policies impact revenue potential:

• Regulatory approval: Regulatory agencies approved cabotegravir for HIV treatment in 2019 (FDA) and for PrEP in 2021.
• Patent protection: Expected to last until mid-2030s; patent expirations could lead to generic entry and price erosion.
• Reimbursement policies: Payers increasingly favor long-acting injectables because of improved adherence, supporting higher reimbursement rates.

Global health initiatives, including WHO guidelines, promote long-acting injectables in HIV management, which could accelerate adoption in low- and middle-income countries.

What Are the Financial Outlooks and Investment Risks?

Revenue Projections

• 2022: Revenues exceeding USD 1.2 billion for ViiV Healthcare's cabotegravir products.
• 2025: Forecasted revenues range between USD 2.5 billion and USD 3.5 billion, assuming strong adoption rates and expanded indications.
• Long-term: Market penetration in emerging markets can add USD 1 billion in annual revenues by 2030.

Risks

• Patent cliffs: Patent expiry in the mid-2030s may open opportunities for generics, undercutting prices.
• Clinical trial failures: Any setbacks in ongoing Phase 3 trials could delay or reduce market entry.
• Regulatory hurdles: Changes or delays in approvals may affect timelines and revenues.
• Pricing pressures: Payer and government negotiations may limit profit margins.

What Are Future Growth Opportunities?

• Expansion into other viral diseases: Explorations in hepatitis B and potential HIV cure strategies.
• Combination regimens: Development of multi-drug long-acting formulations to improve patient compliance.
• Strategic partnerships: Collaborations with biotech firms and governments to increase access and manufacturing capacity.

Key Takeaways

Cabotegravir sodium is positioned for sustained growth in the HIV therapeutics market. Market expansion depends on regulatory approvals, reimbursement policies, and competition from generic entrants post-patent expiration. Investment in R&D to broaden indications could extend its market lifespan.

FAQs

1. What is the primary indication for cabotegravir sodium? Treatment and prevention of HIV/AIDS through long-acting injectable therapy.
2. When did regulatory agencies approve cabotegravir? FDA approved in 2019; EMA followed in 2020.
3. What is the projected market growth rate? Between 4% and 6% CAGR through 2030.
4. Who are the main competitors? ViiV Healthcare, Gilead Sciences, and Merck & Co.
5. When does patent protection expire? Anticipated mid-2030s, risking generic competition.

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References

[1] Global Market Insights. (2023). HIV therapeutics market size analysis. Retrieved from https://www.gminsights.com