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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for CABOTEGRAVIR

International Patents:	157
US Patents:	5
Tradenames:	3
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	46
Patent Applications:	757
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
Ministry of Health, Uganda	Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 3
PPD	Phase 3

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	10,927,129		Y	Y
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	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021		RX	Yes	Yes
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	212888-001	Jan 21, 2021		RX	Yes	Yes	11,389,447
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/004976 Vocabria 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/005756 Apretude 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
Philippines	12007502373	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Japan	2014500849
China	101346376	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Slovenia	3187225
Lithuania	C2465580
South Korea	101504998

Supplementary Protection Certificates for CABOTEGRAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	517	Finland
1874117	122014000066	Germany		PRODUCT NAME: DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DOLUTEGRAVIRNATRIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140116
1874117	1490036-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR ELLER ETT FARMACEUTISKT ACCEPTABELT SALT ELLER SOLVAT DAERAV, INKLUSIVE DOLUTEGRAVIRNATRIUM; REG. NO/DATE: EU/1/13/892 20140116
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
1874117	300676	Netherlands		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
2465580	C202130021	Spain		PRODUCT NAME: CABOTEGRAVIR; NATIONAL AUTHORISATION NUMBER: EU/1/20/1481; DATE OF AUTHORISATION: 20201217; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1481; DATE OF FIRST AUTHORISATION IN EEA: 20201217

CABOTEGRAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cabotegravir

Introduction

Cabotegravir, a long-acting antiretroviral medication, is revolutionizing the treatment and prevention of HIV. Developed by ViiV Healthcare, this drug is part of a broader strategy to enhance patient compliance and reduce the burden of daily treatment. Here, we delve into the market dynamics and financial trajectory of cabotegravir, highlighting its current status, future prospects, and the challenges it faces.

Current Market Status

Cabotegravir is already approved and in use as part of the long-acting injectable regimen Cabenuva, which combines cabotegravir with rilpivirine for the treatment of HIV. This regimen has been endorsed by treatment guidelines and is recognized for its efficacy in maintaining viral suppression in patients who are virologically suppressed on oral antiretroviral therapy (ART)[4].

Long-Acting Injectables

The long-acting injectable (LAI) formulation of cabotegravir has been a game-changer in HIV treatment. It offers patients an alternative to daily oral medications, reducing the complexity and burden associated with adherence. Cabenuva and Apretude, another LAI PrEP option, are driving significant growth in ViiV Healthcare's HIV portfolio[2][3].

Ultra Long-Acting Formulation (CAB-ULA)

A recent breakthrough in the development of cabotegravir is the introduction of an ultra long-acting formulation known as CAB-ULA. This new formulation allows for dosing intervals of at least four months, doubling the current dosing interval of existing long-acting regimens. The phase I clinical trial findings presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2024) showed promising pharmacokinetic, tolerability, and safety data, supporting the advancement of CAB-ULA to the next stage of clinical development[1].

Financial Trajectory

Sales Growth and Projections

ViiV Healthcare's long-acting portfolio, led by cabotegravir, is expected to drive significant sales growth. The company has upgraded its sales compound annual growth rate (CAGR) from mid-single digits to 6-8% for the period 2021-2026, driven by the strong performance of Cabenuva and Apretude. These products are on track to deliver more than £2 billion in sales in 2026, representing about one-third of ViiV Healthcare's total HIV sales[2][3].

Market Share and Competitive Landscape

ViiV Healthcare has increased its global market share by two percentage points in the last year, with Cabenuva and Apretude being key drivers of this growth. The company is now the fastest-growing in the HIV market in terms of both sales and market share. The long-acting portfolio is expected to account for around 40% of ViiV Healthcare's revenue by 2027, significantly transforming the HIV treatment and prevention landscape[2][3].

Challenges and Sustainability

Cost and Insurance Coverage

One of the significant challenges facing the widespread adoption of cabotegravir, particularly in its LAI form, is the high cost. Each injection costs approximately $3,700, and seven injections are recommended per year. This has led to complex coverage and reimbursement issues, straining healthcare systems and causing confusion among patients and healthcare providers[5].

Patient Access and Equity

Despite the advancements, there are concerns about patient access and equity. Low PrEP utilization, especially among marginalized groups, persists due to stigma, inequity, and payer pressure. Ensuring consistent and equitable access to cabotegravir and other long-acting regimens remains a critical challenge[3].

Future Prospects

Extended Dosing Intervals

ViiV Healthcare is committed to further extending the dosing intervals of its long-acting regimens. The roadmap includes achieving every-six-month dosing by the end of the decade, which would significantly reduce the frequency of clinic visits for patients. This innovation is expected to enhance patient compliance and quality of life[2][3].

Combination Therapies

Future studies will explore the potential use of CAB-ULA in combination with other medicines as a complete, ultra long-acting HIV treatment regimen. This could offer patients more flexible and effective treatment options, further solidifying cabotegravir's position in the HIV treatment landscape[1].

Intellectual Property and Revenue Protection

ViiV Healthcare's intellectual property strategy is crucial in protecting its revenue streams. The company's long-acting portfolio, including cabotegravir, is protected by patents until 2031, with potential for further protection beyond this date. This ensures that the revenue generated from these innovative medicines can continue to support future research and development[2][3].

Key Takeaways

• Ultra Long-Acting Formulation: CAB-ULA offers dosing intervals of at least four months, a significant advancement in HIV treatment and prevention.
• Financial Growth: Cabotegravir is driving strong sales growth for ViiV Healthcare, with projected sales of over £2 billion in 2026.
• Market Share: ViiV Healthcare is increasing its global market share, driven by the success of its long-acting portfolio.
• Challenges: High costs and complex insurance coverage issues pose significant challenges to widespread adoption.
• Future Prospects: Extended dosing intervals and combination therapies are on the horizon, enhancing patient compliance and quality of life.

FAQs

What is the current dosing interval for the ultra long-acting formulation of cabotegravir?

The ultra long-acting formulation of cabotegravir, known as CAB-ULA, allows for dosing intervals of at least four months[1].

How is cabotegravir impacting ViiV Healthcare's sales and market share?

Cabotegravir is driving significant sales growth for ViiV Healthcare, with the long-acting portfolio expected to deliver over £2 billion in sales in 2026 and increasing the company's global market share[2][3].

What are the challenges associated with the adoption of cabotegravir in its LAI form?

High costs and complex insurance coverage issues are major challenges, leading to strain on healthcare systems and inconsistent access for patients[5].

What future developments can we expect for cabotegravir?

Future developments include extended dosing intervals, potentially up to every six months by the end of the decade, and exploration of combination therapies[2][3].

How is ViiV Healthcare protecting its revenue streams from cabotegravir?

ViiV Healthcare's intellectual property strategy, including patents until 2031 and potential for further protection, is crucial in protecting its revenue streams from cabotegravir and other long-acting regimens[2][3].

Sources

1. ViiV Healthcare. ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses. March 4, 2024.
2. GSK. Getting ahead of HIV with ViiV Healthcare management. September 28, 2023.
3. GSK. ViiV Healthcare Meet the Management. September 28, 2023.
4. Oxford Academic. Long-Acting Cabotegravir Plus Rilpivirine in People with HIV with Viremia. November 12, 2024.
5. ID Society. From prescription to patient: The lifecycle of cabotegravir for PrEP. June 28, 2023.