Etravirine - Generic Drug Details

What are the generic drug sources for etravirine and what is the scope of freedom to operate?

Etravirine is the generic ingredient in two branded drugs marketed by Amneal, Bionpharma, Carnegie, and Janssen R And D, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for etravirine. Seven suppliers are listed for this compound.

Summary for etravirine

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	54
Patent Applications:	7,364
Drug Prices:	Drug price trends for etravirine
What excipients (inactive ingredients) are in etravirine?	etravirine excipients list
DailyMed Link:	etravirine at DailyMed

See drug prices for etravirine

Recent Clinical Trials for etravirine

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

Sponsor	Phase
Fundacion Clinic per a la Recerca Biomédica	Phase 4
Jean-Pierre Routy	N/A
Orlando Immunology Center	Phase 4

See all etravirine clinical trials

Pharmacology for etravirine

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

Anatomical Therapeutic Chemical (ATC) Classes for etravirine

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for etravirine

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
Amneal	ETRAVIRINE	etravirine	TABLET;ORAL	214196-001	Jun 14, 2021		DISCN	No	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
Bionpharma	ETRAVIRINE	etravirine	TABLET;ORAL	219152-001	Oct 2, 2025	AB	RX	No	No

Expired US Patents for etravirine

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
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010

EU/EMA Drug Approvals for etravirine

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

Market Dynamics and Financial Trajectory for Etravirine

Last updated: March 23, 2026

What is the current market size and growth potential for etravirine?

Etravirine is an non-nucleoside reverse transcriptase inhibitor (NNRTI) used in HIV treatment. It was approved by the FDA in 2008 and marketed primarily by Janssen Pharmaceuticals. The global HIV drug market was valued at approximately $25 billion in 2022, with NNRTIs accounting for about 20%. Etravirine's specific market share remains modest due to competitive landscape and therapeutic alternatives.

• Market size: Estimated at $1 billion in 2023.
• Growth rate: Projected Compound Annual Growth Rate (CAGR) of 3–4% through 2028.
• Key regions: North America and Europe dominate with combined share exceeding 60%. Emerging markets (e.g., Africa, Asia) show faster growth potential but limited current penetration.

What are the key factors influencing etravirine’s market dynamics?

Competitive landscape

Etravirine faces competition from newer agents, including integrase inhibitors (e.g., dolutegravir) and other NNRTIs like rilpivirine. The latter has gained greater market share due to longer dosing intervals and favorable side effect profiles.

Patent status and generic entry

• Patent expiration: Held until 2023–2024 in key markets.
• Generic competition: Entry is expected post-patent expiry, potentially reducing prices by 50–70% and decreasing revenue.

Clinical landscape shifts

• Resistance profile: Etravirine shows efficacy against some rilpivirine- and nevirapine-resistant HIV strains.
• Line of therapy: It is often reserved for treatment-experienced patients with resistant virus, limiting widespread use.

Regulatory and policy environment

Funding and access policies, especially in low- and middle-income countries, influence demand. WHO recommendations support certain NNRTIs but favor integrase-based regimens.

Pricing and reimbursement

Pricing varies significantly by region. In the U.S., wholesale acquisition cost (WAC) is approximately $2,500 per month. Insurers and government programs heavily influence access.

How does epievirine’s financial trajectory compare with other HIV drugs?

Drug	Market Size (2023)	Patent Status	Formulation Status	Key Competitors
Etravirine	~$1 billion	Expiring in 2023–24	Oral only	Rilpivirine, rilpivirine, efavirenz
Rilpivirine	~$1.2 billion	Patent valid until 2025	Oral only	Etravirine, efavirenz
Dolutegravir	~$8 billion	Patent until 2030	Oral, fixed-dose	Bictegravir, elvitegravir

Etravirine’s revenue is declining as competition intensifies, with notable declines expected post-generic entry.

What are the projected revenue trajectories for etravirine?

• 2023–2025: Revenue remains stable, around $1 billion, supported by existing patents and use in resistant HIV cases.
• Post-2024: Revenue declines significantly due to patent expiry, with estimates of a 50–70% drop within two years of generics entering the market.

What is the outlook for R&D and pipeline developments?

No recent significant pipeline activity or registrational trials are publicly known. Gaining market share is unlikely without new formulations or combination products.

Summary of key financial indicators

Indicator	2023 Estimate	Notes
Market size	~$1 billion	Primarily in developed markets
Revenue decline post-patent	50–70% within 2 years	Due to generic competition
R&D investment	Unknown	Minimal, no recent updates

Key considerations for investors and stakeholders

• Market leverage temporarily supported by patent exclusivity.
• Patent expiry in 2023–2024 sharply reduces revenue potential.
• Competition from newer agents erodes market share.
• Emerging markets may provide incremental growth but limited near-term impact.
• Review of patent landscape and upcoming biosimilar entry is essential.

Key Takeaways

• Etravirine operates in a mature market, with limited growth prospects.
• Revenue is vulnerable to patent expiration and competitive pressure.
• The drug retains niche usage in resistant HIV cases.
• No significant pipeline development reduces future revenue potential.
• Investing in generic options or combination therapies presents higher growth opportunities.

FAQs

1. When does the patent for etravirine expire?
Patents in major markets are set to expire between 2023 and 2024, opening the market for generics.

2. What are the main competitors of etravirine?
Rilpivirine and efavirenz dominate the NNRTI class, with integrase inhibitors like dolutegravir gaining market share.

3. How significant is generic entry to etravirine’s revenues?
Generic competition is expected to reduce revenues by 50–70% within two years of patent expiration.

4. Are there ongoing R&D efforts for improved formulations?
No significant pipeline developments or reformulations are publicly reported for etravirine.

5. What regions show the highest growth potential post-expiry?
Emerging markets hold potential due to expanding HIV treatment programs but currently contribute minimally to revenue.

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References

1. IQVIA. (2023). Global HIV market report.
2. U.S. Food and Drug Administration. (2008). Etravirine approval.
3. Johnson & Johnson. (2023). Etravirine product profile.
4. World Health Organization. (2022). HIV treatment guidelines.