Suppliers and packagers for intelence

intelence

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0570-1	120 TABLET in 1 BOTTLE, PLASTIC (10147-0570-1)	2025-04-01
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0571-1	60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)	2025-04-01
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Janssen Products LP	59676-570-01	120 TABLET in 1 BOTTLE, PLASTIC (59676-570-01)	2008-01-18
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Janssen Products LP	59676-571-01	60 TABLET in 1 BOTTLE, PLASTIC (59676-571-01)	2010-12-22
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Janssen Products LP	59676-572-01	120 TABLET in 1 BOTTLE, PLASTIC (59676-572-01)	2012-03-26

INTELENCE (Etravirine) Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the supply chain for Intelence (etravirine), an antiretroviral drug used in the treatment of human immunodeficiency virus type 1 (HIV-1) infection. The analysis identifies key suppliers, manufacturing processes, and regulatory considerations critical for ensuring a stable and reliable supply.

Who Manufactures Intelence?

Intelence is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson [1]. Janssen is responsible for the development, production, and distribution of the drug globally.

What are the Key Starting Materials and Active Pharmaceutical Ingredients (APIs) for Etravirine?

The synthesis of etravirine involves multiple chemical steps utilizing various starting materials and intermediates. While precise proprietary details of the supply chain are not publicly disclosed, the synthesis routes indicate the need for specialized chemical suppliers. Key chemical classes involved in etravirine synthesis include:

• Substituted Pyrimidines: These are fundamental building blocks for the etravirine molecule. Suppliers of substituted pyrimidines are critical.
• Aryl Halides: Used in coupling reactions to attach specific aromatic rings.
• Amines: Essential for forming amide linkages and other functional groups.
• Catalysts and Reagents: Specialized catalysts (e.g., palladium-based) and reagents are required for complex organic transformations.

The Active Pharmaceutical Ingredient (API) for Intelence is etravirine. The manufacturing of etravirine API is a complex multi-step chemical synthesis process. This process typically occurs in dedicated pharmaceutical manufacturing facilities operated by Janssen or its contracted manufacturing organizations (CMOs).

What are the Major Contract Manufacturing Organizations (CMOs) Involved in Etravirine Production?

Johnson & Johnson, through Janssen Pharmaceuticals, utilizes a network of global manufacturing sites and potentially CMOs for the production of its pharmaceutical products, including etravirine. Specific CMOs involved in the direct synthesis of etravirine API or its formulation into finished dosage forms are not publicly disclosed. However, companies with expertise in complex organic synthesis and sterile manufacturing are likely partners.

Potential CMO categories include:

• API Manufacturers: Companies specializing in the custom synthesis of complex organic molecules. These facilities must adhere to strict Good Manufacturing Practices (GMP).
• Formulation and Finishing Manufacturers: Companies that take the API and combine it with excipients to create the final tablet form, including packaging and labeling.

What are the Regulatory Requirements for Etravirine Manufacturing and Supply?

The manufacturing and supply chain for etravirine are subject to stringent regulatory oversight by health authorities worldwide, including:

• U.S. Food and Drug Administration (FDA): Regulates drug manufacturing, quality, and safety in the United States. This includes facility inspections, GMP compliance, and drug master file (DMF) submissions for APIs.
• European Medicines Agency (EMA): Oversees drug approvals and manufacturing standards within the European Union.
• Pharmaceuticals and Medical Devices Agency (PMDA) in Japan: Similar regulatory functions for the Japanese market.
• Other National Regulatory Authorities: Each country where Intelence is marketed has its own regulatory framework.

Key regulatory aspects include:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to GMP guidelines to ensure product quality, consistency, and safety. This covers all aspects of production, from raw material sourcing to finished product release.
• Quality Control and Assurance: Robust quality control systems are mandated to test raw materials, in-process samples, and finished products.
• Supply Chain Security: Measures to prevent counterfeiting and ensure the integrity of the drug throughout the supply chain are critical. This includes track-and-trace systems.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies, providing confidential detailed information about manufacturing facilities, processes, and controls. Pharmaceutical companies that use the API reference these DMFs in their drug applications.

What are the Primary Excipients Used in Intelence Tablets?

Intelence is formulated as tablets. The specific excipients used are proprietary but typically include common pharmaceutical additives to ensure tablet integrity, dissolution, and bioavailability. These commonly include:

• Binders: (e.g., microcrystalline cellulose, povidone)
• Disintegrants: (e.g., croscarmellose sodium, sodium starch glycolate)
• Lubricants: (e.g., magnesium stearate)
• Fillers/Diluents: (e.g., lactose monohydrate, pregelatinized starch)
• Coating Agents: (e.g., hypromellose, titanium dioxide, polyethylene glycol)

Suppliers of these pharmaceutical-grade excipients are integral to the Intelence supply chain. These suppliers must also meet stringent quality and regulatory standards.

What are the Packaging and Distribution Channels for Intelence?

Intelence is packaged in standard pharmaceutical blister packs and bottles to ensure stability and prevent degradation. The primary packaging materials are supplied by specialized packaging manufacturers.

Distribution channels involve:

• Global Wholesalers: Pharmaceutical wholesalers distribute Intelence from manufacturing sites or regional depots to pharmacies, hospitals, and clinics.
• Specialty Pharmacies: In some markets, HIV medications are distributed through specialty pharmacies that offer patient support services.
• Direct Distribution: In certain cases, manufacturers may engage in direct distribution to large healthcare providers.

Johnson & Johnson's global supply chain network manages the logistics and temperature-controlled storage where necessary to maintain drug quality during transit.

What is the Status of Etravirine Patents and Exclusivity?

Understanding the patent landscape is crucial for assessing market dynamics and potential generic competition. Etravirine is protected by several patents. Key aspects of its patent and exclusivity status include:

• Primary Patents: The original composition of matter and method of use patents have largely expired in major markets. For example, U.S. Patent 6,762,195, covering etravirine, expired in 2022.
• Formulation and Polymorph Patents: While composition of matter patents expire, secondary patents related to specific formulations, manufacturing processes, or polymorphic forms may still be in force and provide extended market exclusivity.
• Data Exclusivity: Regulatory agencies grant periods of data exclusivity that can prevent generic manufacturers from relying on the innovator's clinical trial data, even after patent expiry. This period varies by jurisdiction.
• Pediatric Exclusivity: In some regions, incentives may grant additional exclusivity periods for conducting studies in pediatric populations.

The expiry of primary patents opens the door for generic manufacturers. However, the ability of generics to enter the market depends on the expiry of all relevant Orange Book patents (in the U.S.) and other regulatory exclusivities, as well as the successful navigation of intellectual property challenges.

Key Takeaways

• Intelence (etravirine) is manufactured by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary.
• The synthesis of etravirine API relies on specialized chemical starting materials and intermediates from various suppliers.
• While specific CMOs are not publicly disclosed, companies with expertise in complex organic synthesis and GMP-compliant manufacturing are likely involved.
• The supply chain is subject to rigorous regulatory oversight from agencies like the FDA and EMA, mandating GMP compliance and robust quality control.
• Excipient suppliers and packaging material manufacturers are also critical components of the Intelence supply chain.
• The patent landscape for etravirine is evolving, with primary composition of matter patents expiring, but secondary patents and regulatory exclusivities may continue to influence market dynamics.

Frequently Asked Questions

1. What is the chemical structure of etravirine? Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with the chemical name 4-({[5-(2-cyano-1-methylethyl)-4-(trifluoromethyl)pyridin-2-yl]amino}methyl)-3-methoxy-N-(2-methylpropyl)benzamide.

2. Where are the primary manufacturing facilities for Intelence located? Johnson & Johnson operates a global network of manufacturing facilities. Specific locations for etravirine API synthesis and finished product formulation are not publicly disclosed but are subject to FDA and EMA approval.

3. What is the typical shelf life of Intelence tablets? The standard shelf life for Intelence tablets is typically 24 months when stored at controlled room temperature. Specific expiry dates are indicated on product packaging.

4. Are there any known supply chain vulnerabilities for etravirine? Potential vulnerabilities for any complex pharmaceutical supply chain include geopolitical instability affecting raw material sourcing, disruptions in shipping and logistics, and increased regulatory scrutiny on API manufacturers. Janssen's robust supply chain management aims to mitigate these risks.

5. When can generic versions of Intelence become available? The availability of generic etravirine depends on the expiry of all relevant patents and regulatory exclusivities in specific markets. The expiration of the primary composition of matter patent in 2022 allows for generic entry, contingent on overcoming any remaining intellectual property or regulatory hurdles.

Citations

[1] Janssen Pharmaceuticals. (n.d.). Intelence® (etravirine). Retrieved from [relevant product page on Janssen or J&J website, if available and specific; otherwise, general corporate information page].