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 four patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-two patent family members in fifty-one 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 September 5, 2038. 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:	322
US Patents:	4
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:

12,011,506

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 four US patents.

This potential generic entry date is based on patent 12,011,506.

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	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 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	8,080,551
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	7,125,879

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:

Argentina

Australia

Brazil

Canada

Chile

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

Taiwan

United Kingdom

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
African Regional IP Organization (ARIPO)	3551
Australia	2011209788
Australia	2014202404

Supplementary Protection Certificates for JULUCA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1419152	C300529	Netherlands		PRODUCT NAME: RILPIVIRINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ADDITIEZOUT, IN HET BIJZONDER HET HYDROCHLORIDEZOUT; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
1419152	C300532	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN RILPIVIRINE EN ELKE DOOR HET BASISOCTROOI BESCHERMDE THERAPEUTISCH EQUIVALENTE VORM DAARVAN,; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
1419152	PA2012008	Lithuania		PRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128

JULUCA (dolutegravir/rilpivirine) Market Dynamics and Financial Trajectory: Exclusivity, Competition, and Revenue Outlook

Last updated: May 29, 2026

JULUCA (dolutegravir/rilpivirine) is a two-drug antiretroviral regimen for people with HIV who are virologically suppressed on stable therapy. Commercial performance is shaped by (1) HIV market share for integrase inhibitor-based regimens, (2) payer access and formulary placement versus single-pill and long-acting alternatives, and (3) patent and exclusivity timing that governs generic and biosimilar-like substitutes risk.

What is JULUCA (dolutegravir rilpivirine) and how is it positioned in the HIV market?

JULUCA combines dolutegravir (DTG) and rilpivirine (RPV) in a fixed-dose tablet regimen for treatment switching in virologically suppressed adults. It competes in the HIV maintenance segment where prescribers weigh pill burden, lab monitoring needs, drug-drug interaction profiles, and payer preferences.

How does JULUCA’s regimen format affect adoption versus other INSTI-based regimens?

• JULUCA is a maintenance/switch option, not a first-line “start” regimen in most payers’ preferred pathways. That reduces the accessible incident-population pool relative to broad first-line anchors.
• The two-drug format competes against three-drug fixed-dose combinations that dominate volume in many formularies.
• Uptake is sensitive to guideline alignment: where prescribers treat stable suppression patients, JULUCA can capture switches; where “universal regimen” preferences favor other switches, uptake can slow.

Key competitive substitutes in the same therapeutic space

• Other INSTI-based fixed-dose combinations (including once-daily options with broad first-line coverage).
• Long-acting injectable HIV therapies that shift market dynamics by reducing daily pill reliance and changing contracting strategies.
• Separate component access: even before generic entry, payer leverage to force preferred combinations can pressure volume.

What drove JULUCA revenue growth or decline by year?

A full year-by-year financial trajectory requires company-reported sales, segment disclosures, or audited market datasets. This analysis is restricted to patent and regulatory mechanics and market-structure dynamics that directly determine trajectory.

Revenue drivers that typically explain movement in this category

• Share shift within maintenance-switch cohorts: prescriber switching patterns and payer step therapy.
• Pricing and rebate dynamics under managed-care contracts.
• Maintenance duration stability: treated patients remain on regimen if viral suppression persists; discontinuation tends to cluster around safety, resistance, adherence, and drug-drug interaction issues.
• Competitive substitution risk: where alternative regimens gain formulary status, switching reduces net revenue.

When does JULUCA lose exclusivity, and when can generics enter?

JULUCA’s market fate is governed by FDA exclusivities (if any remain) and the expiration schedule of Orange Book-listed patents covering:

• the drug substance(s),
• the fixed-dose combination product,
• formulation and manufacturing,
• and method-of-use claims.

A complete exclusivity calendar cannot be produced without the Orange Book patent list and FDA exclusivity records for the specific approved JULUCA NDA(s). If those were provided, the exact dates and countdowns could be mapped.

What patents protect JULUCA, and what is the likely patent estate strength?

A complete patent-protection map requires the Orange Book “Patent Information” table for JULUCA, including:

• listed patent numbers,
• claim scope (composition, formulation, method),
• expiration dates,
• and regulatory exclusivity fields.

Without the Orange Book listings and associated litigation entries, a quantified “how strong is the estate” assessment cannot be made to the standard required for licensing or enforcement decisions.

How many Paragraph IV challenges exist for JULUCA, and which generic applicants are involved?

Paragraph IV exposure depends on whether any ANDA filings include certifications to Orange Book patents and whether FDA has accepted those applications. Without the ANDA litigation and/or FDA ANDA status list for JULUCA’s relevant patents, the number of challenges and challengers cannot be stated accurately.

What is the Orange Book status of JULUCA, and which patents are most relevant to generic entry risk?

Orange Book status determines:

• what patents must be addressed for an ANDA to launch,
• which patents have already expired,
• and which are still listed with unexpired terms or unexpired regulatory exclusivity.

A correct Orange Book snapshot requires the specific NDA number and the full Orange Book listing for JULUCA. Without that dataset, any listing of patent numbers or expiration dates would not meet a high-stakes decision standard.

How do formulation and method-of-use patents affect JULUCA generic substitution?

In HIV combination products, generic entry risk is often shaped less by broad composition claims and more by:

• combination-specific formulation patents (tablet form, release profile),
• manufacturing method patents,
• and method-of-use or dosing regimen claims tied to approved switching criteria.

A determination of which of these claim types block entry again requires the actual listed patent claims and their expiration timelines.

What patent litigation affects JULUCA (involving Gilead Sciences or other assignees)?

Patent litigation outcomes determine:

• whether FDA approval triggers a launch automatically or is blocked by injunctions,
• and whether settlements delay entry beyond patent expiration.

A defensible litigation chronology requires docketed cases tied to the JULUCA Orange Book patents and the relevant NDA.

What settlement agreements and consent judgments delay generic launch for JULUCA?

Settlement delays are usually communicated through:

• court orders,
• press releases,
• and related filings (e.g., stipulations of dismissal without prejudice, entry of judgment). A complete statement requires case-level settlement terms tied to the Orange Book patent set.

Does JULUCA face biosimilar-like risk or only ANDA-style generic risk?

JULUCA is a small-molecule fixed-dose oral product. That profile implies:

• ANDA-style generic competition risk for the finished drug product,
• not biosimilar pathways (which apply to biologics).

The key remaining risk question is the pace and scope of ANDA launches, driven by patent expiry and any court barriers.

How does JULUCA compare with other HIV regimens on payer access and competitive dynamics?

Market dynamics for HIV maintenance therapy typically hinge on contracting and preferred tier status.

What matters for managed-care formularies

• Coverage for switch therapy: formularies can restrict use to criteria aligned with label and guideline.
• Net price versus alternatives: rebate structures can shift effective cost.
• Step edits for drug-drug interactions and clinically meaningful labs.
• Preference tier: fixed-dose single-tablet regimens often displace multi-step maintenance options when payers seek simplicity.

How long-acting therapies can change the calculus

Long-acting regimens alter retention economics by offering:

• reduced adherence burden,
• changes in clinic workflows,
• and payer willingness to pay a premium based on reduced support costs. That can compress switching into oral regimens if payers steer stable patients into long-acting plans.

What generic entry risks exist for JULUCA under different patent-expiration scenarios?

Generic launch timing depends on:

1. which Orange Book patents expire first,
2. whether courts block based on ongoing infringement claims,
3. whether settlements push entry later than statutory expiry,
4. whether label design-around is required and feasible.

A scenario matrix cannot be completed without the patent expiration set and litigation posture.

Where can generic and branded versions compete geographically?

In the U.S., market entry is dominated by the FDA approval path, Orange Book status, and litigation. International competition depends on:

• local patent term adjustments and enforcement,
• local registration and pricing controls,
• and tender dynamics.

A geography-specific competitive view requires country-level patent status and regulatory submissions.

Key milestones to forecast JULUCA’s next 24–48 months

The primary forecasting inputs are:

• the Orange Book expiration dates for the last-blocking patents,
• any pending Paragraph IV litigation timelines,
• and any FDA regulatory exclusivity expiration tied to the NDA(s).

Without those date fields, any forecast would be speculative.

Key Takeaways

• JULUCA’s financial trajectory is primarily driven by managed-care adoption within HIV maintenance-switch cohorts and competitive displacement from other INSTI-based regimens and long-acting therapies.
• The timing of generic risk is governed by the Orange Book-listed patent set and any associated Paragraph IV challenges and litigation. A precise exclusivity and launch calendar cannot be produced here without the JULUCA Orange Book patent listing and NDA identifier.
• For high-stakes planning (licensing, enforcement, or litigation), the next actionable step is mapping the Orange Book “last expiring” patents and aligning them to the FDA approval-and-certification pathway for ANDA entrants.

FAQs

1. How do payers determine formulary placement for JULUCA versus other INSTI-based fixed-dose combinations?
2. What labeling restrictions affect JULUCA switching eligible populations under payer criteria?
3. When an ANDA is filed for JULUCA, what Orange Book patents typically create the longest launch delays?
4. How do court injunctions versus settlement agreements differ in delaying generic launch for oral HIV combinations?
5. What product characteristics (drug-drug interactions, dosing with food/acid reducers) most influence switching away from JULUCA?

References

No sources are cited because the necessary Orange Book and FDA-specific JULUCA dataset (NDA number, patent list with expiration dates, exclusivity records, ANDA Paragraph IV status, and litigation docket entries) is not included in the prompt.

DrugChatter Q&A for JULUCA

Is Juluca a two-drug regimen?
Is there a generic for Juluca?