cabotegravir; rilpivirine - Profile

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

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

Cabotegravir; rilpivirine has two hundred and eighty-eight patent family members in forty-six countries.

Summary for cabotegravir; rilpivirine

International Patents:	288
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for cabotegravir; rilpivirine

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.

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	212888-001	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
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

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	212888-002	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	212888-002	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	212888-002	Jan 21, 2021
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021

International Patents for cabotegravir; rilpivirine

Country	Patent Number	Title	Estimated Expiration
South Africa	200803423	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Cyprus	1120564
European Patent Office	3284520	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
European Patent Office	2616076
Taiwan	200716635	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Uruguay	30431	SUSPENSIONES ACUOSAS DE TMC278

Supplementary Protection Certificates for cabotegravir; rilpivirine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	C 2014 024	Romania		PRODUCT NAME: DOLUTEGRAVIR SAU O SARE SAU SOLVAT AL ACESTUIAACCEPTABILE FARMACEUTIC, INCLUSIV DOLUTEGRAVIR DESODIU; NATIONAL AUTHORISATION NUMBER: EU/1/13/892; DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/892; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2465580	PA2021512	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
2465580	CR 2021 00010	Denmark		PRODUCT NAME: CABOTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; REG. NO/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
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

Cabotegravir; rilpivirine Market Analysis and Financial Projection

Last updated: February 3, 2026

What is the Market and Therapeutic Role for Cabotegravir and Rilpivirine?

Cabotegravir and rilpivirine are used in combination as long-acting injectable treatments for human immunodeficiency virus type 1 (HIV-1). This combination represents a significant shift from daily oral regimens to monthly or bimonthly injections, improving adherence and reducing pill burden.

Market Landscape

The global HIV treatment market is projected to reach approximately $32.7 billion by 2027, growing at a compound annual growth rate (CAGR) of 4.8% (Fortune Business Insights, 2021). Increasing access to antiretroviral therapy (ART) and an aging patient demographic drive demand.

Key players include Gilead Sciences, ViiV Healthcare (a GSK-Pfizer joint venture), and Janssen. ViiV pioneered cabotegravir/rilpivirine's approval and commercialization.

Regulatory and Commercial Milestones

• Cabotegravir/rilpivirine received FDA approval in January 2021 for HIV-1 treatment.
• The European Medicines Agency approved it in July 2021.
• The treatment is positioned as a first-in-class long-acting option, targeting patients seeking alternatives to daily pills.

What are the R&D and Patent Statuses?

Gilead holds extensive patents related to cabotegravir and rilpivirine. Patent protection extends into the late 2020s for key formulations; however, patent cliffs could emerge around 2025-2028, depending on jurisdictions and patent challenges.

Gilead has invested heavily in formulation technologies for long-acting injectables, securing patents around nanoparticle encapsulation and depot formulations. Pending patents focus on extending exclusivity and reducing generic competition.

What is the Investment Thesis Based on Market Fundamentals?

Revenue Potential

• Projected to reach $1.2 billion globally by 2026 (Frost & Sullivan, 2022).
• Growing adoption driven by preference for long-acting injectables, especially among populations with adherence issues.

Competitive Advantages

• First-in-class status grants market exclusivity.
• Established clinical efficacy and safety profile support adoption.
• Patent protections around formulations delay generic incursions.

Risks and Challenges

• Patent expirations risk generic competition.
• Pricing strategies affect adoption and reimbursement.
• Potential for side effect profiles to limit patient population.
• Regulatory hurdles in emerging markets.

Key Barriers

• High development and manufacturing costs for injectable formulations.
• Complexity of supply chain logistics, including cold chain management.
• Limited long-term real-world data, though ongoing studies aim to fill gaps.

How Do Formulation and Patents Influence Investment Returns?

Patents covering core formulations protect exclusivity for 10 years from filing, typically ending around 2024-2028 depending on jurisdiction. These patents prevent generic manufacturers from producing biosimilars or similar injectables, allowing Gilead to recoup R&D expenses.

Formulation patents extend market power through proprietary depot delivery systems, which are difficult to replicate and provide dosing advantages.

Post-patent expiry, generic competition could reduce prices by 50-70%, impacting margins unless new innovations or indications are developed.

What Is the Long-Term Outlook?

The outlook depends on:

• Extension of market exclusivity through patents or legal extensions.
• Expansion into new indications such as pre-exposure prophylaxis (PrEP).
• Competition from alternative long-acting therapies, including novel delivery methods or newer compounds.
• Global access and pricing strategies in emerging markets.

Gilead and ViiV continue to invest in next-generation formulations and combination therapies, aiming to extend revenue streams beyond the initial patent period.

What Are the Financial and Strategic Risks?

• Patent challenges or invalidations could shorten exclusivity.
• Pricing pressures from payers and governments may squeeze margins.
• Competition from oral regimens with improved profiles.
• Regulatory delays or adverse safety findings.

Summary of Investment Considerations

Aspect	Details	Impact
Market Growth	4.8% CAGR till 2027, $32.7 billion total	Strong growth driver
Patent Extensions	Patent protections into late 2020s	Market exclusivity secured
Competitive Landscape	Gilead, ViiV, Janssen	Intense but manageable with innovation
Pricing and Reimbursement	Pricing flexibility exists but policy-dependent	Risk for profit margins
Global Access	Expansion in emerging markets	Growth potential but logistical challenges

Key Takeaways

• Cabotegravir/rilpivirine offers a long-acting, patent-protected alternative in HIV therapy.
• The market is expanding with rising demand for adherence-focused treatments.
• Patent expiration around 2025-2028 poses revenue risks unless followed by new innovations.
• Investment success hinges on maintaining patent protections, expanding indications, and navigating payer landscapes.
• Competitors are emerging, but current IP and formulation advantages provide buffer.

Frequently Asked Questions

1. When do patents for cabotegravir and rilpivirine expire?
Patent expirations vary by jurisdiction but generally range from 2024 to 2028. Gilead holds key formulation patents extending into the late 2020s.

2. How is pricing for cabotegravir/rilpivirine set?
Pricing is set regionally based on negotiations with healthcare payers, with high launch prices justified by the long-acting convenience and delivery costs. Reimbursement policies significantly affect market uptake.

3. What are the main competitors to this injectable regimen?
Oral ART regimens, including integrase inhibitors and non-nucleoside reverse transcriptase inhibitors, dominate, though long-acting injectables are emerging to replace daily pills.

4. Can new formulations or combinations extend patent life?
Yes. Proprietary formulations, delivery systems, or indications such as PrEP can extend patent life and market exclusivity.

5. What are the key regulatory considerations?
Regulatory agencies closely review safety, efficacy, and manufacturing standards. Delays or adverse findings could impact market entry or expansion into new regions.

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Citations:
[1] Fortune Business Insights. (2021). "HIV Treatment Market Size, Share & Industry Analysis."
[2] Frost & Sullivan. (2022). "Long-Acting HIV Therapies Market Analysis."