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

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

One supplier is listed for this compound.

Summary for cabotegravir; rilpivirine

International Patents:	289
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	31
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

Constraining patent/regulatory exclusivity:

11,389,448

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
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	PHASE4
ViiV Healthcare	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	212888-002	Jan 21, 2021		RX	Yes	Yes	10,927,129		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	12,138,264		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	11,389,448		Y
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	RE50189
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021		RX	Yes	Yes	8,410,103		Y	Y

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	8,080,551
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	7,125,879
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	10,927,129
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	7,125,879
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	8,080,551
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-001	Jan 21, 2021	6,838,464
Viiv Hlthcare	CABENUVA KIT	cabotegravir; rilpivirine	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	212888-002	Jan 21, 2021	6,838,464

International Patents for cabotegravir; rilpivirine

Country	Patent Number	Title	Estimated Expiration
Austria	E516026
Australia	2006239177	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Australia	2006307101	Polycyclic carbamoylpyridone derivative having inhibitory activity on HIV integrase
Brazil	PI0610030	composto, processo para a preparação de um composto, método de tratamento de uma infecção por hiv em um humano, uso de um composto, e, composição farmacêutica
Brazil	PI0617842	composto ou um sal farmaceuticamente aceitável ou um solvato do mesmo, e, composição farmacêutica
Canada	2606282	DERIVE POLYCYCLIQUE DE LA CARBAMOYLPYRIDONE A ACTIVITE INHIBITRICE SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASEINHIBITORY ACTIVITY)
Canada	2626956	DERIVE DE CARBAMOYLPYRIDONE POLYCYCLIQUE AYANT UNE ACTIVITE D'INHIBITION SUR L'INTEGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING INHIBITORY ACTIVITY ON HIV INTEGRASE)

Supplementary Protection Certificates for cabotegravir; rilpivirine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	2014C/038	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND DATE: EU/1/13/892 20140121
2465580	768	Finland
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 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
1874117	2023C/545	Belgium		PRODUCT NAME: DOULUTEGRAVIR SODIQUE; AUTHORISATION NUMBER AND 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
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

Cabotegravir plus Rilpivirine: Market dynamics and financial trajectory

Last updated: April 25, 2026

What is the commercial footprint of cabotegravir plus rilpivirine?

Cabotegravir; rilpivirine (injectable; complete regimen for HIV-1) is marketed in the US and Europe under Cabenuva (ViiV/GSK; based on the oral cabotegravir plus rilpivirine lineage). The business case rests on switching from daily oral antiretrovirals to monthly or every-two-month dosing with long-acting injectables.

Key commercial and product-structure points shaping market dynamics:

Element	What matters commercially	Business implication
Dosing mode	Long-acting intramuscular injections with monthly and every-2-month options	Reduces daily adherence friction; increases switch eligibility but requires clinic workflow and reimbursement stability
Customer pool	Patients stable on suppressive oral regimens and those suitable for switch	Growth depends on physician confidence, payer acceptance, and retention on schedule
Competitive set	Other long-acting options and continued dominance of oral backbones	Pricing and access pressure come from payer preference for oral generics and other long-acting entrants
Form factor	Injection logistics, cold-chain/handling, staffing	Procurement and contracting cycles can be slower than oral drugs; service-level execution affects persistence

Switch propensity is not only clinical. It is payer- and site-of-care-driven, since injectables introduce administered-product and service components (clinic administration, scheduling, inventory management), which can slow uptake even when clinical outcomes are strong.

How does the market evolve under payer and access constraints?

Market dynamics for long-acting HIV injectables typically follow a pattern: initial adoption among specialist sites with strong pipeline participation, then expansion through payer contracts, then stabilization as eligible patient share saturates.

For cabotegravir plus rilpivirine, payer behavior impacts both volume ramp and effective price:

• Reimbursement gating: Plans can require prior authorization tied to stability on therapy, viral suppression history, and injection attendance capacity.
• Formulary positioning vs oral generics: HIV oral regimens include low-cost generics for many lines of therapy; payers may use step therapy for non-suppressed patients.
• Site-of-care economics: Clinics must sustain injection throughput and scheduling. If appointment utilization is low, switching can slow in regions even after formulary approval.
• Persistence as the value driver: The regimen’s unit economics depend on patients returning on time. Missed doses increase fall-back to oral therapy and can reduce net realized demand.

What financial trajectory is consistent with observed commercial behavior?

A reliable financial trajectory requires public disclosures with attributable revenues or company-reported sales broken out for Cabenuva, which are not provided in the input. Under strict completeness constraints, no definitive revenue curve, CAGR, or segment financial contribution can be stated without sourced figures tied to the product.

What can be stated with precision without inventing numbers is the mechanism that drives the financial trajectory for this class:

Revenue drivers

1. Switch volume: number of suppressed patients converted from oral therapy.
2. Dosing frequency mix: patients on every-2-month schedules generally support fewer doses per year than monthly, while still preserving top-line value if pricing is dose-based.
3. Persistence and adherence: on-time injection attendance directly affects continued covered doses.
4. Contracted net price: rebates and payer discounts tied to access status and volume commitments.

Revenue constraints

• Enrollment bottlenecks at clinics (scheduling capacity and staff training).
• Payer pushback when oral generics offer lower-cost alternatives.
• Adoption lag as prescribers transition stable patients and as reimbursement is operationalized.

What key market levers determine competitive position?

Long-acting HIV therapy competition centers on patient retention, tolerability, injection scheduling, and access.

For cabotegravir plus rilpivirine, the levers are:

• Clinical efficacy and virologic suppression performance relative to oral comparators at switching time.
• Operational feasibility: delivery by community or hospital clinics, inventory handling, and appointment compliance support.
• Two-month dosing uptake: higher convenience can improve persistence and reduce appointment burden, supporting revenue stability once penetration is high.
• Switch eligibility criteria: payer policies that restrict to patients meeting suppression and regimen-history criteria.

How do unit economics typically behave for long-acting HIV regimens?

Cabotegravir plus rilpivirine has an injection-centric cost structure and revenue model:

Economic component	Typical behavior	Impact on margin and earnings quality
Drug cost to payer per dose	Negotiated in contracts	Net pricing discipline affects gross margin consistency
Admin and service costs	Charged or bundled by provider systems	Realized value can depend on how payers reimburse administered care
Patient persistence	Improves over time as clinics learn workflow	Higher persistence lifts revenue efficiency by stabilizing throughput
Inventory and handling	Requires forecasting accuracy	Mis-forecasting creates wastage risk and inefficiency for manufacturers and providers

Under these mechanics, the financial trajectory tends to show:

• Early ramp volatility as contracts and clinic workflows align.
• Mid-phase smoothing as eligible populations are worked through and persistence improves.
• Maturity where growth depends on expanding eligible share, sustaining adherence, and defending net price.

What events and policy factors can move the revenue curve?

Even without a numeric revenue line, the following factors are known to move long-acting HIV drug trajectories:

1. Formulary expansion or restrictions by major payers.
2. Site-of-care adoption: whether health systems integrate injection scheduling and reminder programs.
3. Guideline or labeling expansions that broaden switching populations.
4. Competitive entry dynamics: if alternative long-acting regimens gain payer leverage, uptake can shift.
5. Managed care contracting: volume-based rebates and budget caps can change realized revenue.

What does the evidence base imply about demand durability?

The demand durability for cabotegravir plus rilpivirine hinges on ongoing suppression once on therapy and on continued tolerability with injection-based administration. The regimen is positioned for durable treatment with switching advantages over daily therapy.

The pivotal question from a market standpoint is not whether patients respond, but whether they stay on schedule. Long-acting therapies typically show:

• higher durability in mature geographies with established injection infrastructure
• softer persistence in settings with fragmented care or lower injection capacity

How does geographic and institutional mix shape commercial outcomes?

Cabotegravir plus rilpivirine adoption concentrates in:

• specialty and high-volume HIV clinics
• health systems with standardized pharmacy and injection protocols
• regions with payer administrators comfortable with injectable prior authorization workflows

This matters because institutional mix changes over time:

• Short-term growth is driven by centers of excellence.
• Medium-term scaling depends on community clinic integration and payer contracting depth.
• Long-term growth depends on maintaining pipeline switching while sustaining on-schedule return rates.

Key Takeaways

• Cabotegravir plus rilpivirine (Cabenuva) growth depends on switch volume, dosing mix, net price, and persistence, with the major execution variable being clinic-level injection scheduling and reimbursement operations.
• Market expansion is gated by payer reimbursement policies and prior authorization requirements, not only by clinical eligibility.
• The financial trajectory for this product class typically shows an early ramp driven by specialist sites, followed by stabilization as persistence improves, and then maturity-driven growth tied to expanding eligible share and defending contracted net pricing.
• Without sourced product-level financials in the provided material, a quantified revenue curve, CAGR, or margin trajectory cannot be stated.

FAQs

1) Is cabotegravir plus rilpivirine primarily a switch market or a new-start market?

It is positioned primarily for patients who are already virologically suppressed and suitable for switching from oral antiretroviral therapy into long-acting injections, which makes adoption sensitive to payer criteria and clinic workflow.

2) What most strongly affects recurring demand for long-acting HIV injectables?

Persistence and on-time return rates for scheduled injections. Delays or missed doses can shift patients back to oral therapy and reduce repeat dosing volumes.

3) How do payer policies influence realized financial outcomes?

Payers affect realized outcomes through formulary status, prior authorization criteria, rebate structures, and step edits versus oral generics. These determine whether eligible patients can be switched and retained.

4) Why does site-of-care matter in long-acting regimens?

Injectables require clinic scheduling, inventory management, and staff training. Institutional adoption affects throughput and reduces friction for both initial switch and ongoing dosing continuity.

5) What competitive pressure is most relevant?

Pressure comes from oral generic affordability and competing long-acting options that may win formulary leverage. Net price defense and persistence rates become the differentiators once clinical efficacy is broadly established.

---

References

[1] U.S. Food and Drug Administration. Cabenuva (cabotegravir and rilpivirine) prescribing information. FDA.
[2] European Medicines Agency. Cabenuva (cabotegravir, rilpivirine) product information. EMA.
[3] Clinical trial publications for cabotegravir/rilpivirine long-acting regimens (e.g., pivotal switching and maintenance studies).