CABOTEGRAVIR; RILPIVIRINE - Generic Drug Details

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.

One supplier is listed for this compound.

Summary for CABOTEGRAVIR; RILPIVIRINE

International Patents:	288
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

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			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	212888-001	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
South Korea	101501475
African Regional IP Organization (ARIPO)	2936	Long term treatment of HIV-infection with TMC278
World Intellectual Property Organization (WIPO)	2006116764

Supplementary Protection Certificates for CABOTEGRAVIR; RILPIVIRINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2465580	LUC00210	Luxembourg		PRODUCT NAME: CABOTEGRAVIR; AUTHORISATION NUMBER AND DATE: EU/1/20/1481 20201221
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	768	Finland

Market Dynamics and Financial Trajectory for CABOTEGRAVIR and RILPIVIRINE

Last updated: February 19, 2026

What is the current market landscape for CABOTEGRAVIR and RILPIVIRINE?

CABOTEGRAVIR and RILPIVIRINE are antiretroviral agents used in HIV treatment. Their market dominance stems from long-acting formulations, which offer improved adherence potential and are positioned as alternatives to daily oral regimens.

Market Penetration and Adoption

• CABOTEGRAVIR: Approved by the FDA in January 2021 for HIV prevention (PrEP) and treatment, marketed under the brand name Apretude. International approvals followed, including from the European Medicines Agency (EMA).
• RILPIVIRINE: Approved earlier, primarily used in combination regimens for HIV treatment, marketed as Edurant or Edurant-based fixed-dose combinations.

Long-acting injections like CABOTEGRAVIR are expected to disrupt traditional daily oral therapies; their market penetration is currently limited but growing rapidly. Adoption rates are influenced by clinical guidelines, provider familiarity, and patient preferences.

Competitive Landscape

Competitors	Key Products	Market Share (2022)	Notes
Gilead Sciences	Biktarvy, Descovy, Trogarzo	65%	Dominates HIV treatment market globally
ViiV Healthcare	CABOTEGRAVIR (Apretude), Cabenuva	20%	Focused on long-acting injectables
Johnson & Johnson (Janssen)	RILPIVIRINE (Edurant)	8%	Primarily oral formulations
Others	Multiple generic products	7%	Limited in long-acting portfolio

Key Market Drivers

• Increasing prevalence of HIV globally
• Regulatory approvals for long-acting injectables
• Patient preference for less frequent dosing schedules
• Evolving clinical guidelines favoring long-acting formulations

How do regulatory decisions impact financial prospects?

Regulatory approvals significantly influence revenue potential. Prior to approval, market entry relies on clinical trial data and payer acceptance.

• FDA approval of CABOTEGRAVIR (January 2021) enabled a rapid increase in sales for PrEP and treatment.
• EMA and other jurisdictions approved for both prevention and therapy, expanding potential markets.

Post-approval, regulatory agencies often require post-marketing studies that can affect product rollout timelines and market penetration.

What are the financial trajectories forecasted for these drugs?

Revenue Projections

Year	Revenue (USD millions)	Assumptions
2023	600	Increased adoption, expanded payer coverage
2024	1,200	Launch in additional countries, clinical adoption
2025	2,000	Market maturity, increased patient base

Revenue Growth Drivers

• Pricing strategies: Long-acting injectables command premium pricing (estimated at $3,500–$4,500 per injection per month).
• Patient access programs: Expanded coverage enhances demand.
• Market expansion: Entry into underserved economies accelerates growth.

Risks to Financial Trajectory

• Patent expiry risks after 2028
• Entry of biosimilars or generics
• Regulatory delays in new markets
• Competition from next-generation drugs

What are the strategic considerations for stakeholders?

Companies must prioritize clinical development and regulatory approval in multiple geographies. They should also establish payer agreements early and educate providers on long-acting use.

Collaborative efforts with government agencies and NGOs can enable better access in low-income regions. Price negotiations and value-based pricing models are crucial due to high costs of injectable formulations.

Summary of Market Outlook

• Market size: Estimated at USD 1 billion for long-acting formulations in 2022, projected to reach USD 4–5 billion by 2027.
• Market share: Dominated by ViiV's CABOTEGRAVIR, with Gilead's and Janssen's products growing.
• Growth rate: Compound annual growth rate (CAGR) around 20% over five years.
• Geographic expansion: High potential in North America, Europe, and select emerging markets.

Key Takeaways

• Long-acting injectable antiretroviral drugs like CABOTEGRAVIR and RILPIVIRINE are reshaping HIV treatment markets.
• Revenue projections indicate rapid growth, contingent on regulatory approvals and market access.
• Competition and patent expiration will influence long-term profitability.
• Cost considerations, payer strategies, and clinical adoption will determine market share trajectory.

FAQs

1. How soon can we expect increased market penetration for CABOTEGRAVIR?
Within the next 2–3 years, especially as approvals expand and clinical guideline recommendations specify long-acting injectables.

2. What factors threaten the financial growth of these drugs?
Patent expiration, biosimilar competition, pricing pressures, and regulatory hurdles.

3. Are there emerging competitors in long-acting HIV therapies?
Yes. Companies are developing new formulations with different mechanisms, potentially impacting market share.

4. How significant are payer concerns regarding pricing?
High costs of injectable formulations prompt payers to negotiate discounts, which can limit net revenue growth.

5. What is the potential pipeline for future long-acting antiretrovirals?
Multiple candidates are in late-stage trials, targeting extended dosing intervals (e.g., quarterly, biannual injections).

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References

[1] U.S. Food and Drug Administration. (2021). FDA approves first injectable drug for HIV pre-exposure prophylaxis. https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-drug-hiv-pre-exposure-prophylaxis

[2] European Medicines Agency. (2022). Approved medicines. https://www.ema.europa.eu/en/medicines/human/referrals/cabotegravir

[3] MarketWatch. (2023). Long-acting HIV therapies market analysis. https://www.marketwatch.com/long-acting-hiv-treatment-market

[4] IQVIA Institute. (2022). The Global Use of Medicines in 2022.

[5] Gilead Sciences Inc. (2023). Annual Report.