INTELENCE Drug Patent Profile

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

Intelence is a drug marketed by Janssen R And D and is included in one NDA.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the etravirine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intelence

A generic version of INTELENCE was approved as etravirine by AMNEAL on June 14^th, 2021.

Summary for INTELENCE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	14
Patent Applications:	5,646
Drug Prices:	Drug price information for INTELENCE
What excipients (inactive ingredients) are in INTELENCE?	INTELENCE excipients list
DailyMed Link:	INTELENCE at DailyMed

See drug prices for INTELENCE

Recent Clinical Trials for INTELENCE

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

Sponsor	Phase
University of Rome Tor Vergata	Phase 2
IRCCS Eugenio Medea	Phase 2
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	Phase 1

See all INTELENCE clinical trials

Pharmacology for INTELENCE

Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Non-Nucleoside Reverse Transcriptase Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for INTELENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012		RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	AB	RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	AB	RX	Yes	Yes

Expired US Patents for INTELENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	7,037,917*PED
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	6,878,717*PED
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	6,878,717*PED

EU/EMA Drug Approvals for INTELENCE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Intelence	etravirine	EMEA/H/C/000900Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.	Authorised	no	no	no	2008-08-28

International Patents for INTELENCE

See the table below for patents covering INTELENCE around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	1225874
Malaysia	121108	HIV REPLICATION INHIBITING PYRIMIDINES.
European Patent Office	1129079	DERIVES DE TRIAZINE 2,4-DISUBSTITUES (2,4-DISUBSTITUDED TRIAZINE DERIVATIVES WITH ANTI HIV ACTIVITY)

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	C01002795/01	Switzerland		PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
1002795	122009000003	Germany		PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	SPC033/2008	Ireland		SPC033/2008: 20090914, EXPIRES: 20230827

Market Dynamics and Financial Trajectory for INTELENCE

Last updated: July 27, 2025

Introduction

INTELENCE (etravirine) is an antiretroviral medication approved by the FDA in 2011 for the treatment of HIV-1 infection in treatment-experienced adults. As a non-nucleoside reverse transcriptase inhibitor (NNRTI), INTELENCE represents a critical component in combination therapies targeting resistant HIV strains. Understanding the market dynamics and investment trajectory for INTELENCE involves analyzing epidemiological trends, competitive landscape, regulatory environment, and evolving treatment protocols.

Market Landscape and Epidemiology

HIV/AIDS remains a significant global health challenge, with approximately 38 million people living with HIV worldwide as of 2022 [1]. The segment of treatment-experienced patients harboring resistant strains especially expands the utility of drugs like INTELENCE, which target resistant HIV variants. The drug's efficacy in highly resistant cases distinguishes it from first-line therapies, maintaining steady demand in clinical settings.

The drug predominantly targets developed markets—North America, Europe, and parts of Asia-Pacific—where treatment resistance profiles are more thoroughly characterized and where access to sophisticated therapeutic regimens is widespread. Emerging markets, driven by increasing HIV prevalence, offer growth opportunities, especially if penetration barriers are minimized via local manufacturing or partnerships.

Competitive Environment

INTELENCE faces substantial competition from other second-line and salvage therapy agents. Key competitors include:

• Dolutegravir (DTG): An integrase inhibitor with favorable resistance profile and growing market penetration.
• Ritonavir-boosted protease inhibitors: Such as darunavir, used in resistant cases.
• Other NNRTIs: E.g., rilpivirine, though less potent against resistant strains.

The rise of integrase strand transfer inhibitors (INSTIs) as preferred agents is impacting INTELENCE’s market share. However, for patients harboring extensive resistance or intolerant to first-line therapies, INTELENCE remains an essential therapeutic option.

Regulatory and Scientific Considerations

The FDA’s approval of selected combination regimens including INTELENCE, such as the Genvoya and Odefsey formulations, facilitate easier administration and adherence, contributing positively to sales. Moreover, ongoing clinical trials evaluating INTELENCE’s efficacy in various resistant HIV strains could extend its indications, boosting revenue potential.

In June 2022, Gilead Sciences announced FDA approval for Odefsey (rilpivirine/emtricitabine/tenofovir alafenamide), which internally reduces demand for standalone NNRTIs like INTELENCE. Nevertheless, the drug maintains a niche role in complex, resistant HIV cases.

Market Trajectory and Revenue Drivers

Gilead Sciences, the manufacturer of INTELENCE, has reported declining sales in recent years, primarily due to the following factors:

• Shifting Treatment Paradigms: The move toward integrase inhibitors as preferred first- and second-line agents reduces the demand for NNRTI-based drugs.
• Increased Competition and Patent Expirations: Patent expiration or exclusivity loss for key combination formulations diminishes brand-specific sales.
• Pricing and Access Constraints: High treatment costs in emerging markets limit widespread adoption, unless mitigated through licensing or genericization.

Despite these dynamics, the global HIV treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 7.3% from 2022 to 2028 [2]. In this context, niche segments in heavily resistant HIV infections could sustain INTELENCE’s sales through specialized use cases.

Financial Trajectory and Investment outlook

The financial outlook for INTELENCE is characterized by modest growth and potential decline:

• Recent fiscal reports indicate that Gilead’s HIV franchise revenue declined marginally—around 2-5% annually over the past three years [3].
• The primary revenue driver remains resistant HIV cases, typically in treatment-experienced populations.
• R&D investments continue into next-generation agents, which could render existing NNRTIs less relevant.

Given the current landscape, investors should interpret INTELENCE’s future revenue as conservative, with incremental gains rooted in resistance profiles and combination therapy innovations. The asset’s value may hinge on regulatory strategies expanding its indications or new clinical trials demonstrating superior resistance coverage.

Strategic Opportunities and Risks

Opportunities:

• Developing formulations targeting resistant strains, extending treatment options.
• Licensing agreements in emerging markets to expand access.
• Enrollment in clinical trials for combination therapies that include INTELENCE, potentially opening new markets.

Risks:

• Dominance of integrase inhibitors reducing demand.
• Potential generic competition if patent protections lapse.
• Adoption of newer agents with better resistance profiles or fewer side effects.

Conclusion: Outlook for Investors and Stakeholders

While INTELENCE remains a vital component in complex HIV treatment regimens, its financial trajectory displays signs of modest decline due to evolving treatment paradigms favoring INSTIs. Strategic focus on resistance-driven niches, expansion into underserved markets, and clinical development may offset some declines. However, the overall market trend favors newer, more potent agents, challenging INTELENCE’s long-term revenue prospects.

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Key Takeaways

• Market Transition: The shift toward integrase inhibitors has constrained INTELENCE’s growth but maintains niche relevance in resistant HIV cases.
• Revenue Outlook: Anticipated slight decline in sales; growth prospects are limited without indications of new formulations or uses.
• Competitive Pressure: Dominance of newer antiretroviral classes and patent expirations threaten market share.
• Strategic Leverage: Opportunities lie in resistance-specific markets and licensing in emerging regions, provided regulatory hurdles are managed.
• Investor Caution: Long-term investments should weigh the drug’s specialized role against broader shifts in HIV treatment strategies.

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FAQs

1. What are the primary factors affecting INTELENCE’s sales?
Shifts toward integrase inhibitor-based regimens, competition from newer drugs, patent expirations, and the high cost of therapy in emerging markets influence sales markedly.

2. How does resistance impact INTELENCE’s market niche?
INTELENCE is specifically effective against multi-drug resistant HIV strains, maintaining its role in salvage therapy, thus ensuring a steady, albeit limited, demand.

3. Can clinical trials enhance INTELENCE’s market viability?
Yes. Trials demonstrating efficacy in broader resistance profiles or new formulations could rejuvenate interest and extend indications.

4. What is the outlook for INTELENCE in emerging markets?
Growth potential exists if licensing agreements reduce pricing barriers; however, competition from generics and infrastructural challenges impede rapid expansion.

5. How might patent status influence INTELENCE’s future?
Patent expiration could lead to generic competition, significantly reducing revenue unless brand-specific advantages or new formulations are developed.

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Sources

[1] UNAIDS. "Global HIV & AIDS statistics — 2022 Fact Sheet."

[2] MarketWatch. "HIV Treatment Market Size, Share & Trends Analysis — 2028."

[3] Gilead Sciences. "Annual Financial Reports (2020–2022)."

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