Dolutegravir sodium; rilpivirine hydrochloride - Generic Drug Details

What are the generic drug sources for dolutegravir sodium; rilpivirine hydrochloride and what is the scope of patent protection?

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

Dolutegravir sodium; rilpivirine hydrochloride has three hundred and twenty-two patent family members in fifty-one countries.

One supplier is listed for this compound.

Summary for dolutegravir sodium; rilpivirine hydrochloride

International Patents:	322
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	51
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dolutegravir sodium; rilpivirine hydrochloride
DailyMed Link:	dolutegravir sodium; rilpivirine hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dolutegravir sodium; rilpivirine hydrochloride

Constraining patent/regulatory exclusivity:

10,426,780

Dosage:

TABLET;ORAL

^*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.

Pharmacology for dolutegravir sodium; rilpivirine hydrochloride

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
Mechanism of Action	HIV Integrase Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for dolutegravir sodium; rilpivirine hydrochloride

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

Paragraph IV (Patent) Challenges for DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JULUCA	Tablets	dolutegravir sodium; rilpivirine hydrochloride	50 mg/25 mg	210192	1	2019-11-19

US Patents and Regulatory Information for dolutegravir sodium; rilpivirine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	10,426,780		Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	9,242,986*PED				Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	12,011,506		Y

Expired US Patents for dolutegravir sodium; rilpivirine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	6,838,464
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	7,067,522
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	8,101,629

International Patents for dolutegravir sodium; rilpivirine hydrochloride

Country	Patent Number	Title	Estimated Expiration
South Korea	20160003889	ＨＩＶ 통합효소 억제 활성을 가지는 다환식 카르바모일피리돈 유도체 (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
South Korea	101504998
Dominican Republic	P2012000205

Supplementary Protection Certificates for dolutegravir sodium; rilpivirine hydrochloride

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
2932970	122018000125	Germany		PRODUCT NAME: EINE KOMBINATION UMFASSEND DOLUTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z. B DOLUTEGRAVIR NATRIUM) UND RILPIVIRIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON (Z.B RILPIVIRIN HYDROCHLORID); REGISTRATION NO/DATE: EU/1/18/1282 20180516
3494972	2024C/522	Belgium		PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, MET INBEGRIP VAN DOLUTEGRAVIRNATRIUM, EN LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703

Dolutegravir sodium; rilpivirine hydrochloride Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Dolutegravir Sodium and Rilpivirine Hydrochloride?

The market for dolutegravir sodium and rilpivirine hydrochloride is driven by the global HIV treatment landscape. As components of long-acting antiretroviral (ARV) regimens, these drugs are integral to current HIV management strategies. The demand stems from rising HIV prevalence, therapeutic guidelines favoring integrase inhibitors, and a shift toward once-daily, fixed-dose combinations.

Key market factors include patent protections, generic entry, and pricing strategies. The U.S. Food and Drug Administration (FDA) approved dolutegravir-based products initially in 2013, with subsequent approvals expanding indications and formulations. Rilpivirine was approved in 2011, primarily as an alternative to efavirenz owing to better tolerability.

Global HIV prevalence: 38 million (UNAIDS, 2022). Sub-Saharan Africa accounts for approximately 56%, with approximately 1.7 million new infections annually. Treatment coverage gaps and the move toward more tolerable, effective regimens support ongoing demand.

Market size: Estimated at $2.5 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 4% between 2023-2030, driven by expanded access in lower-income countries and ongoing patent protections in key markets.

How Do Patents and Regulatory Approvals Influence Market Trajectory?

Patent status significantly impacts market competition and pricing.

• Dolutegravir: Patents held by GlaxoSmithKline, with expiration dates starting 2028 (e.g., in the U.S.). Generic versions are anticipated post-patent expiry, likely reducing prices by up to 80% in those regions. GSK also manufactures fixed-dose combinations such as Triumeq, which contain dolutegravir. Regulatory approvals for new formulations, such as long-acting injectables, could sustain revenue streams beyond patent expiry.

• Rilpivirine: Patents owned by Janssen Pharmaceuticals, with expiration dates varying globally—most in 2030–2032. Janssen's rilpivirine-based products, such as Edurant, are used in combination regimens. The entry of generics will impact pricing and revenue, but delayed development of alternative formulations may provide interim upside.

Regulatory approvals are evolving to include long-acting injectable formulations, which may redefine market shares. The U.S. FDA approved Cabenuva (cabotegravir and rilpivirine injectable) in January 2021 for maintenance of HIV-1 infection in adults, expanding the product landscape and potentially creating new revenue streams.

What Are the Revenue Drivers and Risks?

Revenue drivers include:

• Expanding global access to affordable regimens.
• Adoption of long-acting formulations like Cabenuva.
• Growing prevalence of treatment-resistant HIV strains requiring newer drugs.
• Strategic partnerships with governments and NGOs.

Risks involve:

• Patent expiration leading to price erosion.
• Competition from generics and biosimilars.
• Slow adoption in resource-limited markets due to infrastructure limitations.
• Regulatory delays for new formulations.

Major pharmaceutical firms with market share include GSK, Janssen, and ViiV Healthcare, a GSK-Janssen joint venture. These companies are investing in clinical trials for long-acting injectable forms, which could constitute a significant revenue source in the next decade.

What Is the Financial Outlook for These Drugs?

Current revenues for dolutegravir and rilpivirine-based products are influenced by patent protections, market penetration, and new formulation launches.

• GSK’s Dolutegravir portfolio generated approximately $1.2 billion in 2022, with a CAGR of 5% over five years.
• Janssen’s rilpivirine franchise earned roughly $300 million in 2022, with projected growth limited by patent cliffs.
• The launch of long-acting injectables is expected to double or triple the annual revenue per drug class within the next five years, based on market analysts’ forecasts.

Generic competition post-patent expiry will largely determine future revenue trajectories, with prices likely declining sharply. The transition to injectable formulations may offset some revenue losses by capturing high-user adherence premiums and lower dosing frequency, which appeal to both patients and healthcare providers.

How Do Global Policies and Market Trends Affect These Drugs?

• WHO’s adoption of integrase inhibitor-based regimens influences treatment guidelines, favoring dolutegravir.
• Initiatives to expand HIV treatment access in Africa and Asia increase demand.
• Patent laws and flexible licensing strategies impact generic markets.
• Weakened patent protections or compulsory licensing in certain countries could accelerate generic entry, pressuring prices but expanding access.

Regional policies substantially affect market penetration. For example, South Africa's government negotiated “project deals” allowing local manufacturing of generics, impacting brand revenues.

Key Takeaways

• The HIV treatment market sustains demand for dolutegravir sodium and rilpivirine hydrochloride due to increasing prevalence and evolving treatment guidelines.
• Patent expiries around 2028–2032 will permit generic competition, significantly reducing prices and revenues.
• Long-acting injectable formulations, such as Cabenuva, are new revenue streams expected to grow rapidly, potentially offsetting patent-related revenue declines.
• Global access programs and policy influences shape future demand, especially in resource-poor countries.
• The market remains competitive, with a focus on innovative delivery methods and formulations to expand patient adherence and treatment outcomes.

FAQs

1. When will generic versions of dolutegravir and rilpivirine become available?
Generic dolutegravir is expected post-2028 in most regions. Rilpivirine generics are anticipated after 2030–2032, depending on patent expirations and regional patent laws.

2. What is the potential of long-acting formulations?
Long-acting injectables like Cabenuva represent a growing segment expected to contribute significantly to future revenues, transforming HIV management practices.

3. How do patent expiries impact pricing in these markets?
Patent expiration typically results in price reductions of up to 80%, opening markets for generics and decreasing revenues for patent-holders.

4. What regions are most influential in shaping market dynamics?
The United States, European Union, and South Africa are key markets due to high HIV prevalence and regulatory influence. Emerging markets in Asia and Latin America are also critical.

5. What is the outlook for revenue growth over the next decade?
Initial growth persists through expanded treatment access, but revenues are expected to decline post-patent expiry unless offset by new formulations and market expansions.

References

[1] UNAIDS. Global HIV & AIDS statistics—2022 fact sheet.
[2] U.S. Food and Drug Administration. Approved HIV and AIDS drugs.
[3] GSK Annual Report 2022.
[4] Janssen Pharmaceuticals. Rilpivirine product information.
[5] MarketWatch. HIV drug market analysis, 2023–2030.