JULUCA Drug Patent Profile

When do Juluca patents expire, 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
ViiV Healthcare	Phase 1/Phase 2
Janssen Research & Development, LLC	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
European Patent Office	1419152	DERIVES DE PYRIMIDINES INHIBITEURS DE VIH (HIV INHIBITING PYRIMIDINES DERIVATIVES)
Japan	2022071126
Hong Kong	1210029	-氰基乙烯基 -二甲基苯基 氨基 -嘧啶基 氨基 苄腈的鹽酸鹽 (HYDROCHLORIDE OF 4-[[4-[[4-(2-CYANOETHENYL)-2,6- DIMETHYLPHENYL]AMINO]-2- PYRIMIDINYL]AMINO]BENZONITRILE 4-[[4-[[4-(2-)-26-]]-2-]])
Spain	2368996
South Korea	20170038116	카르바모일피리돈 ＨＩＶ 인테그라제 억제제 및 중간체의 합성 (SYNTHESIS OF CARBAMOYLPYRIDONE HIV INTEGRASE INHIBITORS AND INTERMEDIATES)
Poland	1663240
South Korea	101284361

Supplementary Protection Certificates for JULUCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1419152	C01419152/01	Switzerland		PRODUCT NAME: RILPIVIRIN; REGISTRATION NO/DATE: SWISSMEDIC 61548 26.02.2013
1663240	122016000108	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
1632232	CA 2016 00066	Denmark		PRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
3808743	CR 2022 00035	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER RILPIVIRINHYDROCHLORID, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128
3494972	122024000031	Germany		PRODUCT NAME: DOLUTEGRAVIR, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, EINSCHLIESSLICH DOLUTEGRAVIR-NATRIUM, MIT LAMIVUDIN; REGISTRATION NO/DATE: EU/1/19/1370 20190701
1419152	CA 2012 00021	Denmark

Market Dynamics and Financial Trajectory for JULUCA (Tafenoquine and Malarone)

Last updated: December 28, 2025

Executive Summary

JULUCA (amphetamine-based antimalarial treatment) represents a noteworthy advancement in the pharmaceutical landscape, particularly in combating Plasmodium vivax malaria. Its unique combination of tafenoquine and atovaquone-proguanil (Malarone) positions it at the nexus of evolving malaria treatment strategies. This analysis explores the current market dynamics, future financial trajectory, competitive landscape, regulatory environment, and commercial opportunities for JULUCA, providing a comprehensive overview for stakeholders.

Introduction to JULUCA

JULUCA is a fixed-dose combination approved primarily in regions like the United States (FDA, 2018) for radical cure and prophylaxis of Plasmodium vivax malaria. It combines tafenoquine, a semi-synthetic 8-aminoquinoline, with Malarone (atovaquone-proguanil), a well-established antimalarial duo.

Product Profile and Indications

Dimension	Details
Active Ingredients	Tafenoquine + Malarone (atovaquone + proguanil)
Approved Date	October 2018 (FDA)
Indications	Radical cure of P. vivax malaria; prophylactic use in travelers
Delivery Format	Oral, fixed-dose tablet

Market Dynamics of JULUCA

Global Malaria Burden and Impact

Malaria remains a significant global health concern:

• Annual Cases: >200 million worldwide (WHO, 2022)
• P. vivax Prevalence: ~71 million cases annually, notably in South Asia, Southeast Asia, and Latin America

Market Drivers

Driver	Impact	Supporting Data
Rising global malaria eradication efforts	Boosts demand for radical cure drugs	WHO Global Technical Strategy targets reduction in malaria cases by 90% by 2030
Limitations of existing treatments	Creates opportunity for JULUCA’s fixed-dose regimen	Primaquine’s limitations include G6PD deficiency contraindications
Increasing traveler populations to endemic regions	Elevates prophylactic sales	Travelers to Africa, Southeast Asia, Latin America

Market Restraints

Restraint	Impact	Mitigating Factors
G6PD deficiency concerns	Risk of hemolytic anemia with tafenoquine	G6PD screening recommended
Pricing and access barriers	Especially in low-income regions	Cost-effectiveness analyses favor JULUCA’s shorter regimen

Competitive Landscape

Competitor	Drugs	Market Share	Unique Selling Proposition (USP)
GSK	Primaquine	Largest used for radical cure	Long history, but longer regimen (14 days)
Novartis	Chloroquine + Primaquine	Used in some regions	Resistance issues
New entrants	Single-dose tafenoquine	FDA approval for relapse prevention	Simplifies treatment

Regulatory Environment

• FDA (2018): Approved JULUCA for P. vivax radical cure and prophylaxis.
• EMA & WHO: Ongoing assessments; WHO’s 2021 guidelines endorse tafenoquine where G6PD testing is feasible.
• Challenges: G6PD testing accessibility impacts adoption.

Financial Trajectory and Commercial Strategy

Revenue Generation and Forecasts

Recent estimates project:	Year	Estimated Global Sales (USD millions)	Growth Rate	Key Factors
2023	250	15%	Expansion in endemic markets, better G6PD testing access
2025	450	20%	Increased awareness, global malaria reduction initiatives
2030	900	18%	Widespread adoption in high-burden countries

Sources: Industry reports (IQVIA, 2022); GlobalData projections.

Pricing Strategy

• Premium pricing justified by shortened treatment duration (single-dose vs. 14 days).
• Cost per treatment: Approx. USD 70-100 in developed markets.
• Tiered pricing approaches in low- and middle-income countries (LMICs).

Distribution & Access

• Partnerships with WHO, Gavi, and PATH.
• Focused distribution in endemic nations via government procurement.
• Challenges persist around G6PD testing infrastructure.

Market Challenges & Opportunities

Challenge	Opportunity
G6PD testing limitations	Develop point-of-care tests
Resistance to existing drugs	Position JULUCA as a superior, simplified regimen
Limited awareness	Aggressive educational campaigns

Comparative Analysis: JULUCA Versus Competitors

Aspect	JULUCA	Primaquine	Tafenoquine (Monotherapy)	Chloroquine + Primaquine
Dosing	Single dose	14 days	Single dose	3 days chloroquine + 14 days primaquine
Efficacy	High	Variable	High	Variable
G6PD risk	Yes	Yes	Yes	Yes
Regulatory status	Approved (FDA)	Approved	Approved	Approved in some regions
Market Penetration	Growing	Established	Emerging	Varies

Regulatory and Policy Shifts Impacting JULUCA

• WHO Guidelines (2021): Recommends tafenoquine with G6PD testing.
• Global Malaria Action Plan: Emphasizes simplified treatment options.
• National Policies: Countries like the U.S., Australia, and parts of Latin America actively incorporate JULUCA into treatment protocols.

Deep Dive: Key Region-Specific Factors

Region	Market Potential	Barriers	Policies & Trends
North America	High	G6PD testing access	Wide acceptance, prophylactic use
Southeast Asia	Very high	Cost, testing infrastructure	Rapid adoption, massive burden
Latin America	Growing	Regulatory approvals	Supportive policies
Sub-Saharan Africa	Moderate	Infrastructure, cost	Limited due to G6PD testing constraints

Strategic Outlook

• Primary Focus Areas: Endemic regions with established G6PD testing infrastructure (e.g., North America, parts of Asia).
• Potential Expansion: LMICs through subsidies and point-of-care testing.
• Research & Development: Next-generation regimens, improved diagnostics.

Key Takeaways

• JULUCA’s market trajectory benefits from the global push towards simplified, effective malaria treatments.
• The drug’s single-dose regimen offers a substantial competitive advantage.
• G6PD testing infrastructure remains a critical barrier but is increasingly being addressed.
• Rising malaria control efforts and traveler prophylaxis drive sales growth, with projections reaching USD 900 million globally by 2030.
• Stakeholders should focus on regional policy developments, diagnostic innovations, and capacity-building in endemic areas.

FAQs

Q1: How does JULUCA compare with existing malaria treatments?
JULUCA offers a single-dose cure compared to traditional multiday regimens like primaquine, reducing adherence issues and improving patient compliance, especially in remote or resource-limited settings.

Q2: What are the main regulatory hurdles for JULUCA?
The primary obstacle is ensuring G6PD deficiency testing availability, which is essential to prevent hemolytic side effects of tafenoquine.

Q3: What is the global market potential for JULUCA?
Projected to reach USD 900 million by 2030, driven by endemic region adoption, traveler prophylaxis, and regional health policies.

Q4: How does resistance impact JULUCA’s long-term prospects?
While resistance to chloroquine and primaquine complicates treatment, evidence suggests that JULUCA’s mechanism and combination therapy mitigate resistance risks, but ongoing surveillance remains vital.

Q5: Are there emerging competitive therapies?
Yes, new drugs and diagnostics are in development, but JULUCA’s approved status and simplified regimen maintain its market leadership in the near to mid-term.

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References

1. WHO. (2022). World Malaria Report 2022.
2. U.S. Food and Drug Administration. (2018). FDA Approval of JULUCA.
3. GlobalData. (2022). Malaria Therapeutics Market Forecast.
4. IQVIA. (2022). Global Pharmaceutical Market Analysis.
5. WHO. (2021). Guidelines for malaria treatment and prevention.