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Last Updated: December 23, 2024

INTELENCE Drug Patent Profile


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When do Intelence patents expire, 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. Five 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 14th, 2021.

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Summary for INTELENCE
Drug patent expirations by year for INTELENCE
Drug Prices for INTELENCE

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Recent Clinical Trials for INTELENCE

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

SponsorPhase
University of Rome Tor VergataPhase 2
IRCCS Eugenio MedeaPhase 2
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaPhase 1

See all INTELENCE clinical trials

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

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 022187-001 Jan 18, 2008 ⤷  Subscribe ⤷  Subscribe
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 ⤷  Subscribe ⤷  Subscribe
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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/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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for INTELENCE

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

Country Patent Number Title Estimated Expiration
Australia 6200899 ⤷  Subscribe
Czech Republic 300712 Cásticová farmaceutická kompozice, pevná disperze a farmaceutická dávková forma, zpusoby jejich prípravy a použití a obchodní balení s jejich obsahem (Particulate pharmaceutical composition, solid dispersion and pharmaceutical dosage form, methods for their preparation and use and business package containing thereof) ⤷  Subscribe
Canada 2350801 PYRIMIDINES INHIBANT LA REPLICATION DU VIH (HIV REPLICATION INHIBITING PYRIMIDINES) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INTELENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1002795 SPC033/2008 Ireland ⤷  Subscribe SPC033/2008: 20090914, EXPIRES: 20230827
1002795 CA 2009 00004 Denmark ⤷  Subscribe
1002795 300373 Netherlands ⤷  Subscribe 300373, 20191101, EXPIRES: 20230827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

INTELENCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INTELENCE

Introduction to INTELENCE

INTELENCE (etravirine) is a prescription medication used in combination with other HIV-1 medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children aged 2 years and older who have previously taken HIV-1 medicines. It is particularly indicated for treatment-experienced patients with viral strains resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) and other antiretroviral agents[2][4].

Regulatory Approvals and Milestones

INTELENCE received accelerated FDA approval in January 2008 for use in treatment-experienced adult patients. It later received traditional FDA approval in November 2009 based on 48-week data from the DUET 1 and DUET 2 studies. In March 2012, the FDA approved INTELENCE for treatment-experienced pediatric patients aged 6 to less than 18 years, making it the only NNRTI indicated for this use in both children and adults with resistance to an NNRTI and other ARVs[4].

Market Position and Competition

INTELENCE operates within the antiretroviral therapy market, which is highly competitive and subject to continuous innovation. The market for HIV treatments is characterized by a range of therapies, including NNRTIs, protease inhibitors, and integrase inhibitors. INTELENCE's unique positioning as a treatment for patients with resistant viral strains gives it a niche market, but it must compete with other antiretroviral drugs and combination therapies[4].

Prescription Trends and Market Share

To understand the market dynamics of INTELENCE, it is crucial to track prescription trends and market share. Tools like Komodo Health's National Drug Projections can provide real-time intelligence on prescription volumes, units dispensed, and new patient starts. This data helps in assessing the performance of INTELENCE against other antiretroviral medications and in identifying market opportunities and competitive landscapes[1].

Financial Trajectory

The financial trajectory of INTELENCE is influenced by several factors, including prescription volumes, pricing strategies, and patient affordability programs.

Revenue and Sales

While specific revenue figures for INTELENCE are not publicly disclosed, the overall market for antiretroviral therapies is substantial. The global HIV treatment market is part of a larger pharmaceutical landscape that is subject to various economic and regulatory factors.

Patient Affordability Programs

Janssen Therapeutics, the manufacturer of INTELENCE, offers several patient affordability programs to make the medication more accessible. For example, the Janssen CarePath program provides a maximum program benefit of $7,500 per calendar year, with no income requirement. These programs help in maintaining patient adherence and can positively impact sales[5].

Impact of Artificial Intelligence in Drug Discovery

The broader pharmaceutical industry, including the segment for HIV treatments, is increasingly leveraging artificial intelligence (AI) in drug discovery. AI can help in identifying latent patterns and correlations within data, predicting drug interactions, efficacy profiles, and safety attributes with heightened precision. While INTELENCE itself is not a product of AI-driven discovery, the evolving landscape of AI in drug discovery could influence future competition and innovation in the HIV treatment market[3].

Geographical Market Presence

The market for INTELENCE is global, but its presence is particularly strong in regions with high HIV prevalence and access to advanced antiretroviral therapies. North America, for instance, is a significant market for many pharmaceutical products, including HIV treatments, due to its advanced healthcare infrastructure and high spending on pharmaceuticals[3].

Therapeutic Area Growth

The therapeutic area of neurology and other diseases is seeing significant growth in the use of AI for drug discovery, but for INTELENCE, the focus remains on HIV-1 infection. The growth in this segment is driven by the need for effective treatments for resistant viral strains and the ongoing research into new antiretroviral therapies[3].

Challenges and Opportunities

INTELENCE faces challenges such as resistance development, competition from newer therapies, and regulatory changes. However, its unique indication for treatment-experienced patients and the ongoing support through patient affordability programs present opportunities for sustained market presence.

Key Takeaways

  • Regulatory Approvals: INTELENCE has received FDA approvals for both adult and pediatric treatment-experienced patients.
  • Market Position: It holds a niche position in the antiretroviral therapy market, particularly for patients with resistant viral strains.
  • Financial Trajectory: Influenced by prescription trends, patient affordability programs, and the broader pharmaceutical market.
  • AI in Drug Discovery: While not directly impacting INTELENCE, AI is transforming the broader pharmaceutical landscape.
  • Geographical Presence: Strong in regions with high HIV prevalence and advanced healthcare infrastructure.

FAQs

  1. What is INTELENCE used for? INTELENCE (etravirine) is used in combination with other HIV-1 medicines to treat human immunodeficiency virus-1 (HIV-1) infection in adults and children aged 2 years and older who have previously taken HIV-1 medicines.

  2. What are the key regulatory milestones for INTELENCE? INTELENCE received accelerated FDA approval in January 2008 and traditional FDA approval in November 2009. It was also approved for treatment-experienced pediatric patients in March 2012.

  3. How does INTELENCE compete in the market? INTELENCE competes within the antiretroviral therapy market, particularly for patients with viral strains resistant to NNRTIs and other antiretroviral agents.

  4. What patient affordability programs are available for INTELENCE? Janssen Therapeutics offers the Janssen CarePath program, which provides a maximum program benefit of $7,500 per calendar year with no income requirement.

  5. How is AI impacting the market for HIV treatments? AI is transforming the broader pharmaceutical landscape by enhancing drug discovery, predicting drug interactions, and improving efficacy and safety profiles, although it is not directly impacting INTELENCE at present.

Cited Sources:

  1. Komodo Health Launches National Drug Projections to Deliver Real-Time Intelligence on Prescription Trends and Market Share - Business Wire
  2. INTELENCE ® (etravirine) Dosing Information - Intelence
  3. Artificial Intelligence in Drug Discovery Market Worth $4.9 Billion - PR Newswire
  4. FDA Approves INTELENCE ® (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review - JNJ
  5. Affordability Options - ID - Janssen CarePath - Janssen CarePath

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