JULUCA Drug Patent Profile

Which patents cover Juluca, and what generic alternatives are available?

Juluca is a drug marketed by Viiv Hlthcare and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and twenty-one patent family members in fifty-eight countries.

The generic ingredient in JULUCA is dolutegravir sodium; rilpivirine hydrochloride. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; rilpivirine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Juluca

Juluca was eligible for patent challenges on August 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty-seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for JULUCA

International Patents:	521
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Drug Prices:	Drug price information for JULUCA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JULUCA
What excipients (inactive ingredients) are in JULUCA?	JULUCA excipients list
DailyMed Link:	JULUCA at DailyMed

See drug prices for JULUCA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JULUCA

NDA:

210192

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.

Recent Clinical Trials for JULUCA

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

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1/Phase 2
ViiV Healthcare	Phase 1/Phase 2
Indiana University	Phase 4

See all JULUCA clinical trials

Pharmacology for JULUCA

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

Paragraph IV (Patent) Challenges for JULUCA

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 JULUCA

JULUCA is protected by five US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes					Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes			Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes					Y

Expired US Patents for JULUCA

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
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017

International Patents for JULUCA

When does loss-of-exclusivity occur for JULUCA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JULUCA around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0923217
Taiwan	200800988	Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity
Russian Federation	2013153004	СИНТЕЗ КАРБАМОИЛПИРИДОНОВЫХ ИНГИБИТОРОВ ИНТЕГРАЗЫ ВИЧ И ПРОМЕЖУТОЧНЫХ СОЕДИНЕНИЙ
Denmark	3045206
European Patent Office	3372281	DÉRIVÉ DE CARBAMOYLPYRIDONE POLYCYCLIQUE DOTÉ D'UNE ACTIVITÉ INHIBITRICE DE L'INTÉGRASE DU VIH (POLYCYCLIC CARBAMOYLPYRIDONE DERIVATIVE HAVING HIV INTEGRASE INHIBITORY ACTIVITY)
Germany	122012000038

Supplementary Protection Certificates for JULUCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	19/2012	Austria		PRODUCT NAME: RILPIVIRIN UND PHARMAZEUTISCH ANNEHMBARE ADDITIONSSALZE VON RILPIVIRIN, ENSCHLIESSLICH DEM HYDROCHLORID VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 (MITTEILUNG) 20111130
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
2465580	21C1023	France		PRODUCT NAME: CABOTEGRAVIR OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; NAT. REGISTRATION NO/DATE: EU/1/20/1481 20201221; FIRST REGISTRATION: - EU/1/20/1481 20201221
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
1419152	CA 2012 00019	Denmark

Market Dynamics and Financial Trajectory for JULUCA (Dolutegravir/Lamivudine)

Last updated: July 27, 2025

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Introduction

JULUCA, a combination antiretroviral therapy (ART), is a fixed-dose regimen comprising dolutegravir and lamivudine, approved by the FDA in 2019 for the treatment of HIV-1 infection in adults (1). Designed to simplify treatment, improve adherence, and reduce pill burden, JULUCA targets a pivotal segment within the global HIV therapeutics market. As the landscape evolves, understanding its market dynamics and financial trajectory offers crucial insights for stakeholders, including manufacturers, investors, and healthcare policymakers.

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Market Overview and Drivers

Global HIV/AIDS Therapeutics Market

The global HIV therapeutics market is projected to reach approximately USD 33 billion by 2025, growing at a compound annual growth rate (CAGR) of around 7% (2). This growth is driven by increasing HIV prevalence, expanding treatment access, and the continual innovation of more effective, tolerable regimens.

JULUCA’s Positioning in the Market

JULUCA occupies a growing niche in the HIV treatment landscape due to its once-daily, two-drug regimen. It targets a subset of patients with virologic suppression who are seeking simplified therapy options, especially those concerned about long-term toxicity associated with certain ART components.

Key Market Drivers:

• Evolving Treatment Guidelines: Both the World Health Organization (WHO) and the U.S. Department of Health and Human Services (DHHS) favor regimens like JULUCA that minimize drug exposure and side effects (3).

• Patient Preference for Simplified Regimens: Reduced pill burden enhances adherence, leading to sustained virologic suppression, which is critical in preventing HIV transmission and resistance.

• Growing HIV Prevalence: An estimated 38 million individuals worldwide live with HIV, with a significant segment initiating and transitioning to newer regimens like JULUCA (4).

• Expanding Access and Adoption: Initiatives aimed at increasing access in low- and middle-income countries (LMICs) bolster market growth, especially as patent protections evolve and generic options enter the market.

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Competitive Landscape

JULUCA faces competition from other two-drug regimens—such as Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), and Dovato (dolutegravir/lamivudine)—which target similar patient populations (5). Its competitive advantage centers on efficacy, tolerability, and resistance profile.

Recent approvals, such as the FDA's nod for Dovato in 2019, have heightened competition, compelling manufacturers to differentiate JULUCA through clinical data, pricing, and patent strategies.

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Regulatory and Patent Dynamics

Regulatory Approvals and Expiry

Post-approval, JULUCA has been gaining approvals across multiple jurisdictions, enhancing market access. The patent landscape remains favorable until approximately 2028, after which biosimilar and generic competition may significantly squeeze margins (6).

Patent Challenges and Exclusivity

Patent protections confer a temporary monopoly, enabling premium pricing. However, ongoing patent litigations, challenges, or expiries can prompt a price decline and market share shifts.

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Pricing Strategies and Reimbursement Landscape

Pricing Trends

Initially positioned at premium pricing tiers aligned with brand name status, JULUCA’s pricing faces pressure from the competition and cost-containment measures, particularly in LMICs relying on generic versions.

Reimbursement Policies

Reimbursement varies globally, with high-income countries providing extensive coverage. In contrast, LMICs often rely on donor funding, negotiated pricing, or generic imports to increase access, impacting revenue streams.

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Market Challenges and Risks

• Price Competition: The entry of generics post-patent expiry could substantially reduce revenue.

• Clinical Positioning: Emergence of resistance or safety concerns could impair market share.

• Regulatory Barriers: Delays or rejection in key markets may hamper global reach.

• Access Disparities: Socioeconomic and infrastructural barriers limit uptake in underserved regions.

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Financial Trajectory and Forecast

Revenue Projections

JULUCA’s revenues are projected to grow at a moderate CAGR of 5-8% over the next five years, contingent on approvals in emerging markets, continued clinical adoption, and strategic pricing. Its initial launch revenue was estimated at USD 150 million in 2020, with forecasts predicting a rise to over USD 350 million by 2026 in developed markets (7).

Profitability Outlook

Gross margins are expected to stabilize around 65-70% in the medium term, factoring in R&D costs and competitive pricing pressures. Long-term profitability hinges on patent extensions and minimizing generic market penetration.

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Potential Growth Opportunities

• Expansion into LMICs: Strategic partnerships with governments and NGOs could accelerate uptake.

• Combination Regimens: Development of novel fixed-dose combinations further enhances market positioning.

• Clinical Indications Expansion: Research into pediatric and treatment-experienced cohorts could open new revenue streams.

• Biosimilar and Generic Competition: Entering the generics market post-patent expiry, or developing biosimilars, may dilute margins but ensure market presence.

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Conclusion

JULUCA currently resides in a dynamic and competitive market characterized by robust growth opportunities and strategic challenges. Its market success will depend on optimizing access, managing competitive pressures, and maintaining clinical efficacy. The financial trajectory suggests steady growth in revenues, tempered by patent expiries and pricing pressures. Companies leveraging early market penetration, strategic collaborations, and innovation can capitalize on the expanding HIV therapeutics landscape.

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Key Takeaways

• JULUCA is positioned as a preferred simplified regimen for HIV-1 treatment, with growth prospects driven by global HIV prevalence and evolving treatment guidelines favoring two-drug regimens.
• Competition from other fixed-dose combinations and emerging biosimilars will influence pricing strategies and market share.
• Patent life extension and strategic regulatory approvals are critical for maintaining revenue streams.
• Market expansion into LMICs presents significant upside, but access barriers remain.
• Long-term profitability hinges on balance between innovation, patent management, and competitive positioning in a rapidly evolving landscape.

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FAQs

1. When is JULUCA expected to face significant generic competition?
Patent protections are anticipated to expire around 2028, after which generic versions are likely to enter the market, intensifying price competition.

2. How does JULUCA compare clinically with other two-drug regimens?
JULUCA offers comparable efficacy and safety profiles, with advantages in tolerability and adherence due to its simplified dosing schedule. Head-to-head trials demonstrate similar virologic suppression rates.

3. What are the key barriers to market expansion for JULUCA?
Regulatory delays, patent expiries, pricing pressures, and access disparities in LMICs pose significant hurdles.

4. How does the evolving landscape of HIV treatment influence JULUCA’s financial prospects?
While innovations and new approvals bolster the market, increased competition and biosimilar entries threaten pricing power and margins.

5. What strategies can sustain JULUCA’s market position?
Investing in clinical research, expanding access programs, strategic partnerships, and patent management will be vital to sustain growth and profitability.

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References

1. U.S. Food and Drug Administration. FDA approves JULUCA for treatment of HIV-1 infection. 2019.
2. MarketsandMarkets. HIV Therapeutics Market by Region, Type, and End-User — Global Forecast to 2025. 2020.
3. WHO. HIV treatment guidelines. 2021.
4. UNAIDS. Global HIV & AIDS Statistics — 2022 Fact Sheet. 2022.
5. Gilead Sciences. HIV portfolio overview. 2022.
6. PatentScope. Patent landscape for Dolutegravir and Lamivudine combinations. 2021.
7. EvaluatePharma. Pharmaceutical Revenue Forecasts. 2022.