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Suppliers and packagers for generic pharmaceutical drug: ETRAVIRINE
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ETRAVIRINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | AvKARE | 42291-473-12 | 120 TABLET in 1 BOTTLE (42291-473-12) | 2022-10-04 |
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | AvKARE | 42291-474-60 | 60 TABLET in 1 BOTTLE (42291-474-60) | 2022-10-04 |
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1720-7 | 120 TABLET in 1 BOTTLE, PLASTIC (60219-1720-7) | 2021-06-14 |
| Amneal | ETRAVIRINE | etravirine | TABLET;ORAL | 214196 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1721-7 | 120 TABLET in 1 BOTTLE, PLASTIC (60219-1721-7) | 2021-06-14 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Etravirine
Introduction
Etravirine, marketed under the brand name Intelence, is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used primarily for the treatment of HIV-1 infection. Since its approval by the U.S. Food and Drug Administration (FDA) in 2008, etravirine has become a pivotal component of antiretroviral therapy. A vital aspect for pharmaceutical companies, healthcare providers, and policymakers involves understanding the global landscape of its suppliers, including manufacturing capacity, geographic distribution, and regulatory status. This article provides an in-depth analysis of the primary suppliers of etravirine, examining manufacturing sources, licensing agreements, and emerging players within the supply chain.
Global Manufacturing Landscape of Etravirine
1. Originators and Original Manufacturers
Initially, Johnson & Johnson's subsidiary, Tibotec (later acquired by Janssen Pharmaceuticals), pioneered the development and commercialization of etravirine. Janssen remains the primary patent holder and manufacturer of branded etravirine (Intelence). The original manufacturing facility was located in Belgium, where the complex chemical synthesis processes were established. Janssen’s global supply chain ensures the medication's availability across major markets, including North America, Europe, and parts of Asia.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity of synthesizing etravirine, production is often outsourced to specialized CMOs. These organizations undertake large-scale chemical synthesis, packaging, and quality assurance processes. Notable CMOs involved include:
- Lonza Group: A Swiss contract manufacturer with extensive expertise in active pharmaceutical ingredient (API) production, including complex antiretroviral compounds.
- Accord Healthcare: An Indian generics manufacturer with capabilities to produce etravirine under licensing agreements, primarily for emerging markets.
- Hikma Pharmaceuticals: Based in the Middle East, Hikma is involved in manufacturing generic versions of etravirine for regional markets.
3. Emerging Generic Suppliers
With patent expiration expected or already initiated in various jurisdictions, the market is witnessing a rise in generic producers. Countries like India, China, and Egypt emerge as key hubs due to their large pharmaceutical manufacturing sectors and favorable regulatory environments.
- Mann Ki Pharma (India): Has secured production licenses for generic etravirine, targeting low- and middle-income countries.
- Cipla (India): Known for extensive antiviral portfolios, Cipla is poised to manufacture and distribute generic etravirine, pending regulatory approval.
- Sinopharm (China): Has been exploring antiviral manufacturing, including HIV medications.
Licensing and Regulatory Approvals
4. Patent Landscape & Licensing Agreements
Johnson & Johnson/Johnson & Johnson's Janssen has maintained patent rights until at least 2025 in key markets such as the U.S., Europe, and Japan. However, licensing agreements have enabled some manufacturers to produce generic versions in regions where patents have expired or are not enforced, especially in developing countries under the provisions of the World Trade Organization’s (WTO) TRIPS waiver.
5. Regulatory Approvals
- United States: The FDA approval process confirms Janssen's manufacturing compliance. Generic manufacturers must navigate Abbreviated New Drug Application (ANDA) pathways, ensuring bioequivalence.
- India and China: Regulatory agencies like the Central Drugs Standard Control Organization (CDSCO) and National Medical Products Administration (NMPA) approve generics adhering to local standards.
Supply Chain Challenges & Opportunities
6. Supply Chain Disruptions
Global disruptions, such as the COVID-19 pandemic, have strained the supply chain due to raw material shortages, regulatory delays, and logistical constraints. Since etravirine synthesis involves complex intermediates often sourced globally, any interruption impacts availability.
7. Market Dynamics & Future Outlook
The expiration of patents and the increasing demand for affordable antiretroviral medications propel the entry of generic manufacturers. Governments and NGOs actively promote local manufacturing to reduce dependency on multinational pharmaceutical companies. Opportunities include strategic licensing, technology transfers, and scale-up of generic production volumes.
Key Players and Strategic Alliances
| Company | Role | Region/Market | Notes |
|---|---|---|---|
| Janssen Pharmaceuticals (Johnson & Johnson) | Original manufacturer, patent holder | Global | Continues to produce branded etravirine and manages licensing agreements |
| Lonza Group | CMO | Global | Supplies pharmaceutical-grade API |
| Cipla | Generic manufacturer | India, Africa, Asia | Approved for derivative formulations and expanding global footprint |
| Mann Ki Pharma | Generic producer | India | Focus on affordability in emerging markets |
| Hikma Pharmaceuticals | Generic manufacturer | Middle East, North Africa | Regional supplier, expanding global presence |
Regulatory and Ethical Considerations
- Patent expiry and access: As patents expire, generic manufacturers gain licensing opportunities, increasing access to HIV therapies in resource-limited settings.
- Quality assurance: Manufacturers must adhere to Good Manufacturing Practices (GMP) established by authorities such as the FDA, EMA, CDSCO, and NMPA to ensure safety and efficacy.
- Pricing strategies: Generics significantly reduce the cost, making HIV treatment more accessible worldwide, aligning with global health initiatives.
Conclusion
The landscape of etravirine suppliers is a dynamic convergence of original brand manufacturers, established CMOs, and emerging generic producers. Janssen Pharmaceuticals remains the core supplier for branded etravirine, leveraging its extensive manufacturing facilities and global distribution channels. Meanwhile, the proliferation of generic manufacturing, predominantly in India, China, and Egypt, is set to increase access, especially for low-income markets, following patent expiration and licensing agreements. Overcoming supply chain disruptions and maintaining rigorous quality standards are essential to ensure consistent availability and efficacy. Strategic licensing, technological advancements, and regional manufacturing initiatives will shape the future of etravirine supply, ensuring broader access to vital HIV treatments.
Key Takeaways
- Johnson & Johnson's Janssen remains the primary supplier for patented etravirine, with manufacturing concentrated in Belgium and other high-standard facilities.
- Generics are emerging rapidly, especially in India, China, and the Middle East, driven by patent expirations and regional licensing agreements.
- Contract manufacturing organizations (CMOs) like Lonza play a critical role in API production, supporting both branded and generic supply chains.
- Regulatory compliance, quality assurance, and supply chain resilience are imperative to meet global demand, especially amid logistical disruptions.
- Strategic alliances and licensing facilitate broader access, with focus on affordability in resource-limited settings, aligning with global HIV treatment targets.
FAQs
1. Who are the leading global suppliers of etravirine?
Janssen Pharmaceuticals is the primary supplier for the patented drug, while India’s Cipla, Discover, and Mann Ki Pharma are prominent generic manufacturers expanding supply, especially in emerging markets.
2. Are there regional differences in etravirine manufacturing?
Yes. Manufacturing for branded etravirine is centralized primarily in Europe, whereas generics are produced mainly in India, China, and Egypt, driven by regional licensing agreements and patent laws.
3. How does patent expiration affect the supply of etravirine?
Patent expiration opens the market for generics, increasing supply sources, reducing prices, and improving access, especially in low-income regions.
4. What challenges face the supply chain of etravirine?
Disruptions include raw material shortages, COVID-19 impacts, regulatory delays, and manufacturing capacity constraints. Ensuring quality and consistent supplies remains critical.
5. What role do licensing agreements play in etravirine supply?
Licensing enables generic manufacturers to produce etravirine legally, enhancing global access, especially where patents are not enforced or have expired, complying with international agreements like WTO/TRIPS.
References:
[1] U.S. Food and Drug Administration. Approved Drug Products: Intelence (Etravirine). 2008.
[2] Janssen Pharmaceuticals. Product Information for Intelence. 2022.
[3] World Health Organization. Access to HIV medicines in low- and middle-income countries. 2021.
[4] Global Data. Pharmaceutical Contract Manufacturing Market Analysis. 2022.
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