Cabotegravir; rilpivirine - Generic Drug Details

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

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

Cabotegravir; rilpivirine has four hundred and eighty-five patent family members in fifty-three countries.

One supplier is listed for this compound.

Summary for cabotegravir; rilpivirine

International Patents:	485
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabotegravir; rilpivirine
DailyMed Link:	cabotegravir; rilpivirine at DailyMed

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

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; rilpivirine

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE1
ViiV Healthcare	PHASE4
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	PHASE4

See all cabotegravir; rilpivirine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for cabotegravir; rilpivirine

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

US Patents and Regulatory Information for cabotegravir; rilpivirine

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
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021		RX	Yes	Yes			Y	Y
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

Expired US Patents for cabotegravir; rilpivirine

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	212888-001	Jan 21, 2021
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 cabotegravir; rilpivirine

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	2109	Combinations of a pyrimidine containing NNRTI withRT inhibitors
China	117298114
Denmark	1419152
Slovenia	1874117
World Intellectual Property Organization (WIPO)	2006024667
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)

Supplementary Protection Certificates for cabotegravir; rilpivirine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	PA2021512,C2465580	Lithuania		PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
1874117	PA2014021,C1874117	Lithuania		PRODUCT NAME: DOLUTEGRAVIRAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS, ISKAITANT DOLUTEGRAVIRO NATRIO DRUSKA; REGISTRATION NO/DATE: EU/1/13/892/001, 2014-01-16 EU/1/13/892/002 20140116
1663240	1690062-3	Sweden		PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1632232	SPC/GB17/007	United Kingdom		PRODUCT NAME: A COMBINATION OF RILPIVIRINE HYDROCHLORIDE AND TENOFOVIR ALAFENAMIDE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REGISTERED: UK EU/1/16/1112 (NI) 20160623; UK PLGB 11972/0019 20160623
3808743	LUC00275	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU D'UNE FORME THERAPEUTIQUEMENT EQUIVALENTE DE CELLE-CI PROTEGEE PAR LE BREVET DE BASE, TELLE QU'UN SEL D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE, ET D'EMTRICITABINE; AUTHORISATION NUMBER AND DATE: EU/1/11/737/001-002 20111128
1419152	CA 2012 00019	Denmark

Market Dynamics and Financial Trajectory for the Pharmaceutical Combination: Cabotegravir & Rilpivirine

Last updated: September 16, 2025

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Introduction

The pharmaceutical landscape for antiretroviral therapy (ART) has evolved rapidly, driven by innovations that aim to enhance treatment adherence, reduce side effects, and improve patient quality of life. Cabotegravir and Rilpivirine, two potent agents within this domain, have garnered increased attention due to their distinct pharmacological profiles and clinical benefits. Since their debut, the combination of Cabotegravir (an integrase strand transfer inhibitor) and Rilpivirine (a non-nucleoside reverse transcriptase inhibitor) has marked a paradigm shift, introducing long-acting injectable formulations for HIV-1 treatment.

This analysis examines the current market dynamics, projected financial growth, and emerging trends influencing the trajectory of this combination therapy, highlighting opportunities, challenges, and strategic considerations for stakeholders.

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Market Overview

Current Clinical Landscape & Adoption

The shift toward long-acting injectable HIV therapies is rooted in the need to improve adherence among populations facing challenges with daily oral regimens. Cabotegravir and Rilpivirine's approval by regulatory agencies, notably the U.S. Food and Drug Administration (FDA) in 2021, positioned it as a groundbreaking option for injectable maintenance therapy in virologically suppressed adults [1].

Industry reports estimate that the global HIV therapeutic market is projected to reach USD 28 billion by 2026, with the long-acting injectable subset comprising a significant growth driver due to superior patient compliance and reduced dosing frequency [2].

Key Market Players and Collaborations

ViiV Healthcare, a Johnson & Johnson subsidiary, developed and commercialized this combination, underlining its strategic focus on specialized HIV treatment solutions. GSK and other pharma entities are investing heavily to develop similar long-acting agents; however, ViiV’s early approval and market penetration grant it a competitive edge.

Strategic collaborations include partnerships with healthcare providers and public health organizations to facilitate access, especially among marginalized populations. The rollout has initially centered in North America and Europe, with emerging markets exploring regulatory pathways.

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Market Dynamics Influencing Financial Trajectory

Clinical Efficacy and Patient Preference

Long-acting injectables directly address adherence issues associated with daily oral ART. Clinical trials demonstrate non-inferior efficacy and fewer adverse events compared to traditional regimens, reinforcing market acceptance [3]. As a result, healthcare providers show increasing willingness to prescribe these therapies, fueling sales and revenue growth.

Regulatory and Reimbursement Environment

Robust regulatory approvals have enhanced market confidence. However, reimbursement policies remain a barrier in some regions, particularly regarding coverage for injectable therapies and associated clinic visits. Positive reimbursement frameworks in the U.S., driven by Medicare and private insurers, bolster sales projections.

Pricing Strategies and Market Penetration

Pricing remains a key factor. The injectable formulation's higher per-dose cost must be weighed against its clinical and adherence benefits. ViiV Healthcare has adopted premium pricing for the dual-drug injectable, aiming to offset development costs and establish a lucrative market position. Market penetration will depend on payers’ willingness to reimburse and patients’ acceptance of the injectable modality.

Patent Lifespan and Generic Competition

Currently, U.S. patents for the combination extend into the late 2020s, offering exclusivity. The potential emergence of generic or biosimilar competitors after patent expiry could significantly impact revenues. Nonetheless, formulation patents and delivery methods may provide additional barriers to immediate competition.

Emerging Markets and Access Considerations

Expanding access in low- and middle-income countries (LMICs) is critical for sustained growth. International funding agencies like PEPFAR and the Global Fund are exploring subsidized procurement options. However, logistical challenges and pricing models will influence market share in these regions.

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Financial Projections and Trends

Revenue Forecasts

Market analysts project that initial sales of Cabotegravir and Rilpivirine injectables will reach USD 1 billion within 3-5 years post-launch, driven by increasing adoption among treatment-experienced and treatment-naïve patients [4]. The growth rate is expected to average 20-25% annually over the next decade, contingent upon market expansion and competitive dynamics.

Market Penetration Strategies

Key strategies include expanding clinical indications, such as PrEP (pre-exposure prophylaxis), which could broaden the revenue base. Additionally, targeted marketing for specific demographics — including adolescents and marginalized populations — can accelerate adoption.

Cost Considerations

Production costs are decreasing due to manufacturing process efficiencies. Yet, high research and development (R&D) expenses, regulatory costs, and the need for continuous safety monitoring will shape profit margins. Economies of scale and volume-driven procurement are expected to improve profitability over time.

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Emerging Trends and Future Outlook

Innovation and Formulation Enhancements

Next-generation formulations, including subcutaneous implants or extended-release techniques, are in R&D pipelines, promising to further extend dosing intervals and improve convenience. Such innovations could disrupt current market dynamics by offering even more patient-friendly options.

Market Expansion and Competitive Landscape

While ViiV remains dominant, competition from other pharmaceutical giants investing in long-acting ART, such as GSK’s initiatives and collaborations involving Teva or Mylan, is anticipated. Market saturation in high-income countries may trigger focus on emerging markets, where unmet needs remain significant.

Regulatory & Policy Impacts

Evolving policies favoring differentiated care models and simplified regimens will support growth. International guidelines recognizing long-acting injectables as standard options could accelerate uptake globally.

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Key Challenges and Risks

• Pricing and Reimbursement Constraints: High treatment costs and limited insurance coverage can hinder widespread adoption.
• Clinical Limitations: Some patients may prefer oral medications; injection site reactions may affect adherence.
• Patent Expiry and Biosimilar Entry: Patent cliff could introduce competition, impacting profit margins.
• Logistical Challenges: Storage, cold chain requirements, and healthcare infrastructure need optimization, especially in LMICs.

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Conclusion

The combined market for Cabotegravir and Rilpivirine reflects robust growth prospects, driven by clinical efficacy, therapeutic convenience, and strategic commercialization. While initial revenue streams are promising, sustained growth hinges on expanding access, navigating reimbursement landscapes, and innovating delivery mechanisms. Stakeholders should carefully evaluate regional demands, competitive moves, and regulatory developments to maximize financial returns and optimize patient outcomes.

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Key Takeaways

• The long-acting injectable formulation of Cabotegravir and Rilpivirine offers a landmark advancement in HIV therapy, with promising commercial potential.
• Market growth is propelled by improved adherence, favorable clinical data, and evolving treatment guidelines supporting injectable regimens.
• Pricing, reimbursement strategies, and patent protections are critical determinants of future revenue streams.
• Expanding access in emerging markets and integrating next-generation technologies will be pivotal for sustained growth.
• Ongoing innovation and competitive dynamics necessitate agility and strategic planning among industry players.

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FAQs

1. What are the main advantages of Cabotegravir and Rilpivirine over traditional oral HIV regimens?
The key benefits include improved adherence owing to less frequent dosing, reduced pill burden, and potentially fewer side effects, leading to better viral suppression and quality of life.

2. What are the primary challenges facing market expansion for this combination?
High costs, limited reimbursement in certain regions, logistical challenges related to cold chain storage, and patient preference for oral therapy are principal hurdles.

3. How does patent life influence the financial outlook of Cabotegravir and Rilpivirine?
Patent expiry around late 2020s could open the market to generics and biosimilars, significantly impacting sales and profitability unless secondary patents or formulations extend exclusivity.

4. Are there any new indications or formulations in development for this combination?
Yes, research into extended-release implants, subcutaneous devices, and broader indications such as PrEP is ongoing, aiming to further enhance convenience and expand market reach.

5. What role do regulatory agencies play in shaping the market trajectory?
Regulatory approvals facilitate market entry and influence adoption rates. Clear pathways and supportive policies, especially for programs targeting LMICs, are essential for rapid expansion.

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Sources:

[1] U.S. FDA, "FDA Approves First Long-Acting Injectable for HIV Treatment," 2021.
[2] MarketWatch, "Global HIV Therapeutics Market Forecast to 2026," 2022.
[3] Clinical trials data from GSK and ViiV Healthcare, "CaboRil Trial Results," 2022.
[4] Pharma Market Research, "Long-Acting Injectable HIV Therapies: Market Projections," 2023.