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 eight 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:	508
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

Constraining patent/regulatory exclusivity:

10,426,780

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.

This potential generic entry date is based on patent 10,426,780.

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	7,125,879		Y	Y
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017		RX	Yes	Yes	8,129,385*PED				Y
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	12,011,506		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	6,838,464
Viiv Hlthcare	JULUCA	dolutegravir sodium; rilpivirine hydrochloride	TABLET;ORAL	210192-001	Nov 21, 2017	8,101,629
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	8,080,551

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
World Intellectual Property Organization (WIPO)	2006024668
Finland	3494972
World Intellectual Property Organization (WIPO)	2007049675
Ukraine	105556

Supplementary Protection Certificates for JULUCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1663240	122015000085	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
3808743	122022000051	Germany		PRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE EIN PHARMAZEUTISCH AKZEPTABLES ADDITIONSSALZ VON RILPIVIRIN, EINSCHLIESSLICH DES SALZSAEURESALZES VON RILPIVIRIN, UND EMTRICITABIN.; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1663240	CA 2015 00055	Denmark		PRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2932970	PA2018013	Lithuania		PRODUCT NAME: DERINYS, APIMANTIS DOLUTEGRAVIRA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., DOLUTEGRAVIRO NATRI) IR RILPIVIRINA ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA (PVZ., RILPIVIRINO HIDROCHLORIDA); REGISTRATION NO/DATE: EU/1/18/1282/001-002 20180516

Market Dynamics and Financial Trajectory for Juluca

Introduction

Juluca, a groundbreaking 2-drug regimen comprising dolutegravir and rilpivirine, was approved by the US FDA in November 2017 for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed. This approval marked a significant shift in HIV treatment, offering a simpler and potentially more tolerable option for patients.

Approval and Regulatory Landscape

Juluca was the first 2-drug regimen (2DR) to be approved, consisting of dolutegravir, an integrase strand transfer inhibitor, and rilpivirine, a non-nucleoside reverse transcriptase inhibitor. The FDA approval was based on the SWORD phase III program, which demonstrated the efficacy and safety of switching from a three-drug regimen to Juluca in virologically suppressed patients[1][4].

Market Impact

The introduction of Juluca has significantly impacted the HIV treatment market by providing a more streamlined treatment option. This 2-drug regimen reduces the number of antiretroviral agents patients need to take, which can lead to improved adherence and reduced side effects.

Patient Benefits

• Simplified Treatment: Juluca offers a once-daily, single-pill regimen, which can enhance patient compliance and quality of life.
• Tolerability: Clinical trials, such as the SWORD studies, have shown that Juluca maintains viral suppression with a favorable safety profile, including improvements in bone markers over three years[4].

Market Reception

• Physician Acceptance: The approval of Juluca has been welcomed by healthcare providers as it provides an innovative alternative to traditional three-drug regimens. Experts like Professor Chloe Orkin and Dr. John C. Pottage Jr. have highlighted its effectiveness and tolerability[4].

Financial Performance

The financial trajectory of Juluca is closely tied to the performance of its parent company, ViiV Healthcare, and its shareholders, including GlaxoSmithKline (GSK), Pfizer Inc., and Shionogi Limited.

Revenue Contribution

• Sales Growth: Juluca has contributed to the revenue growth of ViiV Healthcare and GSK. While specific revenue figures for Juluca are not isolated, the overall performance of GSK's Specialty Medicines segment, which includes HIV treatments, has shown significant growth. For instance, in 2023, GSK reported strong sales growth across Specialty Medicines and Vaccines, with new products launched since 2017 contributing over £11 billion to sales[3].

Market Expansion

• Global Reach: Juluca has been approved in several countries, including the US, EU, and others, with further regulatory submissions pending. This global expansion has helped in increasing its market reach and revenue potential[1][4].

Competitive Landscape

The HIV treatment market is highly competitive, with multiple antiretroviral therapies available. However, Juluca's unique position as a 2-drug regimen sets it apart.

Competitive Advantage

• Innovation: Juluca's approval marked the beginning of a new era in HIV treatment, offering a simpler and potentially more tolerable option. This innovation has given it a competitive edge in the market[1].

Clinical and Research Developments

The long-term efficacy and safety of Juluca have been supported by extensive clinical trials.

SWORD Phase III Program

• Three-Year Data: The SWORD studies have provided three-year data, demonstrating that Juluca maintains viral suppression and has a favorable safety profile. These findings have reinforced its position as a viable long-term treatment option[4].

Financial Projections and Outlook

The financial outlook for Juluca is positive, driven by its growing market acceptance and the expanding portfolio of ViiV Healthcare and GSK.

Future Growth

• Pipeline Strengthening: GSK and ViiV Healthcare continue to strengthen their pipelines with new HIV treatments and prevention options. This includes potential new medicines for long-acting HIV treatment and prevention, which could further bolster the financial performance of Juluca and related products[3].

Market Trends

• Increasing Demand: The demand for simpler, more effective HIV treatments is increasing, driven by patient needs and healthcare provider preferences. This trend is expected to continue, supporting the financial trajectory of Juluca[1].

Challenges and Opportunities

While Juluca has made significant strides, there are challenges and opportunities to consider.

Regulatory Challenges

• Compliance and Approval: Maintaining regulatory compliance and securing approvals in new markets are ongoing challenges. However, ViiV Healthcare's strategic submissions and approvals in various regions have mitigated these risks[1].

Market Opportunities

• Expanding Patient Base: The potential to switch more patients from traditional three-drug regimens to Juluca presents a significant market opportunity. This could be driven by continued clinical evidence supporting its efficacy and safety[4].

Key Takeaways

• Innovative Treatment: Juluca is the first approved 2-drug regimen for HIV treatment, offering a simpler and potentially more tolerable option.
• Strong Clinical Data: The SWORD phase III program has provided robust three-year data supporting its long-term efficacy and safety.
• Financial Growth: Juluca has contributed to the revenue growth of ViiV Healthcare and GSK, with a positive financial outlook driven by market expansion and pipeline strengthening.
• Competitive Advantage: Its unique position as a 2-drug regimen sets it apart in the competitive HIV treatment market.

FAQs

What is Juluca, and how is it different from other HIV treatments?

Juluca is a 2-drug regimen consisting of dolutegravir and rilpivirine, approved for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed. It is different because it is the first once-daily, single-pill regimen, reducing the number of antiretroviral agents patients need to take.

Who are the key players involved in the development and marketing of Juluca?

Juluca is developed and marketed by ViiV Healthcare, a global specialist HIV company majority-owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders.

What are the clinical benefits of Juluca?

Juluca has been shown to maintain viral suppression with a favorable safety profile, including improvements in bone markers over three years. It also offers a simpler treatment regimen, which can enhance patient compliance and quality of life.

How has Juluca impacted the HIV treatment market?

Juluca has introduced a new era in HIV treatment by providing a more streamlined and potentially more tolerable option. This has been welcomed by healthcare providers and patients, contributing to its growing market acceptance.

What are the future prospects for Juluca in terms of market growth and financial performance?

The future prospects for Juluca are positive, driven by its growing market acceptance, expanding global reach, and the strengthening pipeline of ViiV Healthcare and GSK. Continued clinical evidence and regulatory approvals are expected to support its financial growth.

Sources

1. GSK Press Release: "Juluca® (dolutegravir and rilpivirine) approved in US as first 2-drug regimen, once-daily, single pill - a complete regimen for the maintenance treatment of virologically suppressed HIV-1 infection."
2. Shionogi Financial Report: "1st Half (Interim period) of Fiscal 2024 Financial Results."
3. GSK Annual Report 2023: "Annual Report 2023 | GSK."
4. ViiV Healthcare Press Release: "ViiV Healthcare announces Juluca maintains viral suppression at 148 weeks."
5. GSK Press Release: "Full-year and fourth quarter 2022 - GSK."