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. Six 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:	120
Clinical Trials:	14
Patent Applications:	4,367
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

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

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

International Patents for INTELENCE

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	106521
Croatia	P20080359	PIRIMIDINI KOJI INHIBIRAJU REPLIKACIJU HIV-a (HIV REPLICATION INHIBITING PYRIMIDINES)
African Intellectual Property Organization (OAPI)	11675	2,4-Disubstituted triazine derivatives.
Norway	319788
Israel	143024
Slovakia	287270

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2008016	Lithuania		PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
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	C01002795/01	Switzerland		PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
1002795	337	Finland
1002795	SPC033/2008	Ireland		SPC033/2008: 20090914, EXPIRES: 20230827

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