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, Carnegie, and Janssen R And D, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for etravirine

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	54
Patent Applications:	6,242
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
Carnegie	ETRAVIRINE	etravirine	TABLET;ORAL	215402-001	Apr 13, 2022	AB	RX	No	No
Carnegie	ETRAVIRINE	etravirine	TABLET;ORAL	215402-002	Apr 13, 2022	AB	RX	No	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
Amneal	ETRAVIRINE	etravirine	TABLET;ORAL	214196-003	Jun 14, 2021	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	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
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012	6,878,717*PED
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008	7,887,845*PED

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/000900 Intelence, 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

Etravirine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Etravirine

Introduction to Etravirine

Etravirine is an antiretroviral medication specifically designed for the treatment of HIV-1, particularly in cases where the virus has developed resistance to other antiretroviral drugs. This medication plays a crucial role in managing HIV-positive patients who have evolved through various resistance profiles.

Market Drivers

The Etravirine market is driven by several key factors:

Rising Prevalence of HIV/AIDS

The increasing global prevalence of HIV/AIDS is a significant driver of the Etravirine market. As more people are diagnosed with HIV, the demand for effective antiretroviral treatments, especially for drug-resistant strains, continues to grow[1][3][5].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing regions, have enhanced access to HIV treatments. This expansion is crucial for the growth of the Etravirine market[1][3][5].

Government and NGO Initiatives

Government initiatives and programs by non-governmental organizations (NGOs) aimed at increasing accessibility to HIV medications have positively impacted the market. These initiatives often include awareness programs, subsidies, and distribution networks that make Etravirine more accessible[1][3].

Personalized Medicine and Combination Therapies

The shift towards personalized medicine and combination therapies has increased the demand for Etravirine. Its effectiveness in treating drug-resistant HIV strains makes it a valuable component of advanced treatment plans[1][3][5].

Market Restraints

Despite the positive drivers, the Etravirine market faces several challenges:

Competition from Generic Alternatives

The rise of generic alternatives poses a significant threat to the market. Generic versions of Etravirine can be more affordable, which may attract price-sensitive consumers, especially in developing markets[1][3].

Regulatory Barriers

Stringent regulatory environments, particularly in North America and Europe, can delay product approvals and impact market penetration. Different regulatory frameworks across regions also add complexity to the market dynamics[1][3].

High Cost and Economic Constraints

The high cost of Etravirine, combined with economic constraints faced by many healthcare systems, is a major hurdle. This can limit the market's potential, especially in regions with limited healthcare budgets[1][3].

Market Opportunities

Several opportunities are emerging that could shape the future of the Etravirine market:

Patient-Centric Approach

Adopting a patient-centric approach by providing personalized treatment plans can enhance market penetration. Collaborations with local clinics and health centers can improve the acceptance and distribution of Etravirine[3].

Partnerships with Global Health Organizations

Leveraging partnerships with global health organizations can enhance the distribution of Etravirine in developing regions. Such partnerships can help in overcoming logistical and financial barriers[3].

Research and Development

Continuing research and clinical trials examining the application of Etravirine in combination medicines offer significant growth potential. Innovations in drug formulations and delivery systems are also expected to drive demand[1][3][5].

Regional Market Analysis

The Etravirine market varies significantly across different regions:

North America

North America, led by the United States, is currently the largest market for Etravirine. Canada also plays a significant role in this region. The strong regulatory frameworks and well-developed healthcare systems in these countries support stable market growth[1].

Asia-Pacific

The Asia-Pacific region, particularly countries like China and India, is expected to experience the fastest growth. Increasing HIV prevalence and improving healthcare access in these regions are key drivers[1].

Europe

In Europe, countries such as Germany and the U.K. are significant players, driven by strong regulatory frameworks and robust healthcare systems. The economic conditions and cultural acceptance of HIV treatment also influence demand in these regions[1].

Financial Trajectory

The financial outlook for the Etravirine market is promising:

Current Market Size

As of 2023, the Etravirine market size was estimated at USD 251.67 million, with projections to reach USD 257.34 million in 2024[3].

Projected Growth

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 3.34% to 3.70% from 2024 to 2030, reaching approximately USD 316.78 million to USD 1.9 billion by 2031, depending on the source[1][3][5].

Revenue Projections

The revenue projections indicate steady growth, driven by increasing demand for effective antiretroviral treatments and the ongoing need for managing drug-resistant HIV strains. The market size is expected to expand significantly over the forecast period, reflecting the evolving needs of HIV patients globally[1][3][5].

Competitive Landscape

The Etravirine market is predominantly led by Janssen Therapeutics, a subsidiary of Johnson & Johnson, which holds a significant market share due to its comprehensive HIV treatment portfolio. Other key players include Gilead Sciences and Merck & Co., which focus on innovative antiretroviral therapies and combination treatments[1].

Key Takeaways

• The Etravirine market is driven by the rising prevalence of HIV/AIDS and the need for effective antiretroviral treatments.
• Advancements in healthcare infrastructure and government initiatives are crucial for market growth.
• The market faces challenges from generic alternatives, regulatory barriers, and high costs.
• Opportunities exist in adopting patient-centric approaches, partnerships with global health organizations, and ongoing research and development.
• The market is expected to grow steadily, with significant regional variations.

FAQs

What is Etravirine used for?

Etravirine is an antiretroviral medication used for the treatment of HIV-1, particularly in cases where the virus has developed resistance to other antiretroviral drugs[1].

What are the key drivers of the Etravirine market?

The key drivers include the rising prevalence of HIV/AIDS, advancements in healthcare infrastructure, government and NGO initiatives, and the shift towards personalized medicine and combination therapies[1][3][5].

What are the main challenges facing the Etravirine market?

The main challenges include competition from generic alternatives, stringent regulatory barriers, and the high cost of the medication combined with economic constraints[1][3].

Which regions are expected to see the fastest growth in the Etravirine market?

The Asia-Pacific region, particularly countries like China and India, is expected to experience the fastest growth due to increasing HIV prevalence and improving healthcare access[1].

Who are the leading players in the Etravirine market?

The leading players include Janssen Therapeutics, Gilead Sciences, and Merck & Co., with Janssen Therapeutics holding a significant market share[1].

Cited Sources:

1. Etravirine Market Forecasts, Market Trends and Impact Analysis - OpenPR
2. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in ... - JAMA Network
3. Etravirine Market Size & Share 2025-2030 - 360iResearch
4. Etravirine in treatment-experienced HIV-1-infected children - AIDS
5. Etravirine Market Size, Share, Growth | Global Report, 2031 - Market Research Intellect