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. Seven 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:	5,443
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

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
China	1325387
Israel	143023
African Regional IP Organization (ARIPO)	1636	2.4-disubstituted triazine derivatives.
Slovakia	285240
Hungary	227453	HIV REPLICATION INHIBITING PYRIMIDINES, AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Hungary	228449	ANTIVIRAL COMPOSITIONS
Austria	233740

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	300373	Netherlands		300373, 20191101, EXPIRES: 20230827
1002795	09C0004	France		PRODUCT NAME: ETRAVIRINE AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/08/468/001 DU 20080828; REGISTRATION NO/DATE AT EEC: EU/1/08/468/001 DU 20080828
1002795	CA 2009 00004	Denmark
1002795	SPC/GB09/003	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/003 GRANTED TO JANSSEN PHARMACEUTICA NV IN RESPECT OF THE PRODUCT ETRAVIRINE OPTIONALLY IN A FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6342 DATED 08 DECEMBER 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 AUGUST 2023.
1002795	337	Finland
1002795	91528	Luxembourg		91528, EXPIRES: 20230828
1002795	PA2008016	Lithuania		PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828

Market Dynamics and Financial Trajectory for INTELENCE (Etravirine)

Last updated: February 20, 2026

What are the current market fundamentals for INTELENCE?

INTELENCE (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for treatment-experienced adults living with HIV-1. Launched by Janssen Pharmaceuticals in 2014, the drug targets patients who have developed resistance to first-line therapies. As of 2023, INTELENCE maintains a niche positioning within the antiretroviral (ARV) segment.

Total global sales for the drug reached approximately $230 million in 2022, declining from a peak of $310 million in 2017. The decline correlates with a shift toward newer ARV agents with improved efficacy and dosing convenience.

The drug’s market share in HIV treatment regimens remains limited, constituting 2-3% of the total ARV market measured at approximately $8.3 billion globally (IQVIA, 2022). The primary geographic markets include North America (notably the U.S.), Europe, and select Asian-Pacific countries.

What are the key competitive pressures affecting INTELENCE?

Emergence of Newer Agents

The entry of highly potent, once-daily drugs such as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) and Dovato (dolutegravir/lamivudine) has reduced the prevalence of complex, resistance-focused regimens. These agents offer simplified dosing and lower side effect profiles, decreasing the role of etravirine in first- and second-line treatment.

Patent and Regulatory Status

INTELENCE's patent expired in the U.S. in 2021, enabling generic competition in certain markets. Although Janssen has sought extensions and new formulations, generics are available in some regions, pressuring sales and pricing.

Clinical Positioning

The drug remains relevant for treatment-experienced patients with extensive resistance profiles. However, the overall patient population qualifying for INTELENCE shrinks as newer agents demonstrate efficacy across broader resistance patterns and more convenient dosing.

How do patent and regulatory policies impact financial prospects?

Patent Expiry and Generics

The U.S. patent expiration in 2021 led to the introduction of generics, which reduced market prices by approximately 25-30%. Contract manufacturers and regional distributors now offer generic versions at lower prices, eroding profit margins.

Regulatory Developments

Janssen has filed for supplemental indications to expand INTELENCE's label to include pediatric cases and once-daily fixed-dose combinations, aiming to extend sales relevance. Regulatory approvals in Europe and Asia influence regional sales trajectories, with approvals granted in several countries between 2019 and 2021.

What are the future sales drivers and growth opportunities?

Expansion into Developing Markets

Emerging markets account for about 25% of global HIV treatment sales. Janssen's efforts to secure registration and inclusion in national formularies can expand access for resistant cases. Product affordability remains a challenge but can be mitigated through tiered pricing and partnerships.

New Formulations and Combinations

Development of fixed-dose combinations incorporating etravirine may improve adherence and expand indications, especially for patients with complex resistance patterns. Early-stage pipeline projects aim to incorporate INTELENCE into once-daily regimens targeted at treatment-experienced populations.

Potential Repositioning

Janssen's investigational studies examine INTELENCE's role in pre-exposure prophylaxis (PrEP). Although early, successful outcomes could unlock a new market segment, potentially reviving sales trajectories.

How does competition compare in the HIV ARV space?

Agent	Market Share (2022)	Dosing Schedule	Resistance Profile	Status
Biktarvy	45%	Once daily	Broad	Market leader
Dovato	20%	Once daily	Broad	First-line alternative
Tivicay	15%	Once daily	Broad	Resistance management
INTELENCE	3%	Twice daily	Limited to resistant cases	Niche, resistance-specific

What are the financial risks and opportunities moving forward?

Risks

• Pricing pressure due to generic competition and regional price controls.
• Market shrinkage given the shift toward simpler, more tolerable drugs.
• Limited pipeline innovation may restrict life-cycle management.

Opportunities

• Expanding resistant patient population as treatment options evolve.
• Geographic expansion into underserved markets with high resistance prevalence.
• Potential label extensions into pediatric and prophylactic indications.

Key financial metrics and projections

Year	Estimated Global Sales	YoY Change	Major Drivers
2023	$200 million	-13%	Patent expiry, generic competition
2024	$180 million	-10%	Continued generic erosion, market consolidation
2025	$150 million	-17%	Market saturation, competition intensifies

Note: These estimates assume current market dynamics persist.

Key Takeaways

• INTELENCE remains a niche HIV drug primarily for resistant cases, with sales declining due to generics and competition from newer agents.
• Patent expiration has led to price erosion and reduced profitability.
• Growth hinges on expanding access in emerging markets, developing new formulations, and exploring novel indications.
• The drug's future is limited without pipeline innovations or strategic repositioning.

FAQs

1. Will INTELENCE regain market share?
Unlikely—market trends favor drugs with simplified dosing and broader resistance coverage, diminishing INTELENCE’s role.

2. How significant is patent expiry impact?
Major; generic entry in 2021 reduced prices and sales volume, with further erosion expected as generics penetrate more markets.

3. Are there any new formulations in development?
Janssen has announced ongoing studies on fixed-dose combinations and pediatric formulations, aiming to extend market relevance.

4. Can INTELENCE be used for PrEP?
Early research explores this possibility, but regulatory approval and clinical data are pending.

5. How does regional variation affect global prospects?
Emerging markets with high resistance prevalence offer growth potential, especially if affordability can be addressed through tiered pricing models.

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References

1. IQVIA. (2022). Global HIV drug sales report.
2. Janssen Pharmaceuticals. (2023). INTELENCE product monograph.
3. U.S. Patent and Trademark Office. (2021). Patent expiration date for etravirine.