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
IRCCS Eugenio Medea	Phase 2
University of Rome Tor Vergata	Phase 2
Fundacio Lluita Contra la SIDA	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
African Regional IP Organization (ARIPO)	1683	HIV replication inhibiting pyrimidines.
Argentina	024227	PIRIMIDINAS INHIBIDORAS DE REPLICACION DE HIV, UN PROCESO PARA SU PREPARACION, EL USO DE LAS MISMAS PARA LA MANUFACTURA DE UN MEDICAMENTO, COMPOSICIONES FARMACEUTICAS, Y UN PROCESO PARA PREPARARLAS
Austria	233740
Austria	455107
Australia	2011200708
Australia	6200899

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	PA2008016	Lithuania		PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
1002795	CA 2009 00004	Denmark
1002795	300373	Netherlands		300373, 20191101, EXPIRES: 20230827
1002795	91528	Luxembourg		91528, EXPIRES: 20230828
1002795	PA2008016,C1002795	Lithuania		PRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	SPC033/2008	Ireland		SPC033/2008: 20090914, EXPIRES: 20230827

INTELENCE (etravirine) market dynamics and financial trajectory: exclusivity, competitive pressure, pricing, and revenue outlook

Last updated: July 21, 2026

INTELENCE (etravirine), a Janssen antiretroviral for HIV-1, faces sustained competitive pressure from dolutegravir- and bictegravir-based regimens and broader first-line guideline preference. After patent and regulatory exclusivity overhangs, the product has shifted from growth to steady decline dynamics in most mature markets, with revenue durability driven by (1) continued use in treatment-experienced patients with resistance profiles and (2) persistent uptake in combination therapy where alternative options are constrained by resistance or tolerability.

What is INTELENCE (etravirine) and how is it used in HIV treatment?

INTELENCE is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination antiretroviral therapy for adults with HIV-1 infection with evidence of NNRTI resistance.

Regimen role

• Typical clinical positioning: treatment-experienced patients with resistance to NNRTIs, where etravirine retains activity against many resistant variants relative to earlier NNRTIs.
• Product behavior: tends to track the resistant-HIV segment, which is smaller than first-line naïve cohorts.

Core commercial driver

• Persistence in salvage/resistance-driven prescribing rather than first-line conversion. That mix shift is the central determinant of revenue trajectory post-major policy shifts toward integrase inhibitor (INSTI)-dominant regimens.

How has the HIV standard of care changed and what does it do to INTELENCE demand?

Guideline evolution is the primary macro demand headwind.

Demand shift mechanics

• Earlier NNRTI-centered regimens lost share as INSTIs became preferred first-line.
• In many formularies, INSTI-based fixed-dose combinations displaced NNRTI regimens where they offered similar efficacy with improved tolerability and resistance characteristics.

Downstream market effect

• Smaller addressable market for new starts.
• Greater reliance on ongoing prescriptions for patients already stabilized on NNRTI-containing regimens and those where etravirine is clinically favored due to resistance pattern.

What patents protect INTELENCE and how do patent cliffs affect revenue?

A patent estate shapes the speed of generic erosion, segment retention, and originator leverage in licensing.

Patent estate impact framework

• If meaningful formulation or method-of-use protections remain, generics typically launch later or with narrower label scope.
• If composition-of-matter protections expire, generic entry can still be slowed by bioequivalence tooling, manufacturing process know-how, and any remaining secondary IP barriers.

Commercial consequence

• Originator revenue tends to show accelerated decline around credible generic entry windows and around any settlement that brings forward or delays launch.

When does INTELENCE lose exclusivity and when do generics become a real threat?

Exclusivity loss timing determines entry probability and speed.

Featured-snippet answer

• The practical threat window for revenue is the combination of (1) Orange Book final relevant expiration for listed patents and (2) the entry date of the first approved generic(s) in key markets, plus any settlement-driven timing.

Market reality for INTELENCE

• Even without a single “cliff,” INTELENCE has faced a multi-year exclusivity and competitive transition typical of mature HIV ARVs, where competitive substitution happens before formal patent expiry because prescribers move to newer regimens.

What is the Orange Book status of INTELENCE and how many ANDAs threaten the market?

Orange Book status is the regulatory scoreboard for small-molecule generic competition.

What to expect in the dataset (business interpretation)

• Each listed patent maps to a generic approval/Paragraph IV strategy.
• The number of ANDAs and their litigation posture influence the degree of price compression and payer switching.

Commercial impact

• In mature ARVs, even limited generic presence can compress net pricing rapidly through tendering and formulary substitution. Originators then defend via contracting, rebates, and patient-assistance channels.

What generic entry risks exist for INTELENCE and how fast does price erosion happen?

Generic erosion pattern in mature HIV

• Price declines often accelerate after first generics establish supply, followed by incremental pressure from additional entrants.
• Rebate intensity increases as payers lock in lower net prices.

Segment-specific resilience

• Salvage/resistance populations can slow switching versus naïve patient pools because prescribers may avoid changing a suppressive regimen without a clear clinical reason.
• However, as therapy ages and lines-of-therapy shift, the originator’s remaining base shrinks.

Which companies compete with INTELENCE and what is their substitution advantage?

Competitive set includes:

• INSTI-based regimens as therapeutic alternatives.
• NNRTIs that compete in overlapping resistance contexts (class competition).
• Generic etravirine if/when launched, competing primarily on price and access.

Substitution advantages

• INSTIs: better guideline position, fixed-dose combination convenience, and broad efficacy across resistance patterns.
• Generics: net-price compression through rebate negotiations and payer channel control.

How does INTELENCE compare with dolutegravir- and bictegravir-based regimens commercially?

Commercial comparison

• First-line displacement: INSTI regimens capture new starts, reducing “top-of-funnel” demand for INTELENCE.
• Formulary breadth: INSTI combinations often win preferential tiers due to fewer monitoring and simplified switching.

Residual value of INTELENCE

• Resistance-dependent use cases can keep etravirine relevant after INSTI dominance.
• That residual pool tends to be smaller and more expensive to defend commercially due to payer pressure for the cheapest clinically adequate option.

What formulation patents or method-of-use protections can slow generic substitution for INTELENCE?

Where present, they can delay “at-launch” substitution even if composition-of-matter has expired.

Protection types that matter to market dynamics

• Solid oral dosage formulation improvements (bioavailability and stability).
• Manufacturing process claims (scale-up, polymorph control).
• Method-of-use claims that lock coverage to specific resistance-defined populations.

Business effect

• If any secondary IP remains enforceable, generics may face delayed launch or narrower labeling strategies, buying time for contract defense and patient retention.

What patent litigation affects INTELENCE and what settlements matter for market timing?

Litigation posture is a leading indicator of launch timing.

How to interpret litigation outcomes commercially

• Sustained injunctions: delay generic entry and keep net pricing higher for longer.
• Settlements: can create “pay-for-delay” type timing effects that may postpone generic competition.
• Dismissals or adverse court decisions: accelerate generic entry windows.

What is the FDA regulatory status of INTELENCE and what lines of therapy does it cover?

INTELENCE is an FDA-approved HIV-1 therapy under a NNRTI class with use tied to treatment-experienced adults.

Regulatory status implications

• Label-driven prescribing constraints keep use more concentrated than broad-spectrum first-line regimens.
• That concentration increases sensitivity to guideline shifts and resistance testing practices.

How do distribution channels and payer contracting affect INTELENCE net price and revenue?

For mature ARVs, channel mechanics often determine the financial trajectory more than wholesale demand.

Key contracting dynamics

• PBM and payer formulary placement: influences volume.
• Rebate structures: determine net price.
• Tender dynamics in some regions: force rapid downward pricing when generics enter.

Net revenue behavior

• Gross-to-net compression can outpace volume decline if originators lose formulary position or if payer contracts reset to match lowest-available prices.

INTELENCE revenue trajectory: what typically happens to sales after HIV INSTI standardization?

INTELENCE’s financial path in most markets follows a common pattern for older HIV brands:

1. Early post-peak: stabilization driven by the remaining resistant/salvage base.
2. Medium-term: steady decline as INSTI-based regimens take share and patients cycle through lines of therapy.
3. Later phase: accelerated decline around generic entry or major contracting reset events, if they occur.
4. Residual durability: maintenance in subpopulations where resistance and history favor etravirine.

What KPIs should investors track for INTELENCE going forward?

Market and commercial KPIs

• Share of prescriptions within NNRTI-containing combinations (not just total HIV).
• Net price vs list price movement after rebate resets.
• Volume trends in treatment-experienced segments and across major geographies.
• Generic penetration: number of stocked SKUs and rebate differentials.
• Channel data: payer coverage rate and prior authorization frequency.

Geographic differences: where does INTELENCE typically perform better and why?

More durable markets

• Regions where second-line and salvage therapy management relies heavily on existing regimen libraries.
• Markets with slower payer formulary turnover or where generic penetration is delayed.

Faster decline markets

• Regions with rapid formulary reclassification toward INSTI fixed-dose combinations.
• Countries where generic etravirine entry accelerates net pricing immediately.

Key Takeaways

• INTELENCE faces structural demand headwinds from INSTI-led guideline shifts that reduce new-start share.
• Commercial resilience depends on continued use in treatment-experienced and resistance-defined populations.
• Revenue trajectory is likely to show steady long-run decline with periodic step-downs tied to generic entry and payer contracting resets.
• Litigation and Orange Book-linked exclusivity timelines determine the speed and magnitude of generic price erosion.
• Sustained financial impact is most sensitive to net-price dynamics (rebates and tendering) rather than only absolute patient counts.

FAQs

1. How does etravirine dosing in treatment-experienced HIV affect market demand compared with first-line INSTI regimens?
2. Do payer policies change faster for HIV NNRTIs than for INSTI-based fixed-dose combinations, and how does that impact net sales?
3. What is the typical revenue profile of older NNRTI brands once integrase inhibitor dominance is established in formularies?
4. How do settlement-driven generic launch dates influence originator net pricing for mature HIV small molecules?
5. What manufacturing and supply-chain constraints most often determine how quickly generic etravirine prices compress in key countries?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. INTELENCE (etravirine) Prescribing Information.
3. IAS-USA and DHHS/NIH HIV treatment guidelines (latest available versions).

DrugChatter Q&A for INTELENCE

Intelence 2023 sales janssen?
Intelence 2023 sales etravirine?