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Suppliers and packagers for eloxatin
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eloxatin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1731-10 | 1 VIAL, GLASS in 1 CARTON (0955-1731-10) / 10 mL in 1 VIAL, GLASS | 2015-09-01 |
| Sanofi Aventis Us | ELOXATIN | oxaliplatin | INJECTABLE;INTRAVENOUS | 021759 | NDA AUTHORIZED GENERIC | Winthrop U.S, a business of sanofi-aventis U.S. LLC | 0955-1733-20 | 1 VIAL, GLASS in 1 CARTON (0955-1733-20) / 20 mL in 1 VIAL, GLASS | 2015-09-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Drug: Eloxatin
Introduction
Eloxatin, known generically as oxaliplatin, is a platinum-based chemotherapeutic agent primarily used in the treatment of colorectal cancer and other gastrointestinal malignancies. Its role in combination chemotherapy regimens, such as FOLFOX (folinic acid, fluorouracil, and oxaliplatin), underscores its significance in oncology. As a critical component of cancer therapy protocols, understanding the global supply landscape of Eloxatin is essential for pharmaceutical companies, healthcare providers, and policymakers to ensure uninterrupted patient access and supply chain resilience.
This article explores the current suppliers of Eloxatin, highlighting manufacturing sources, distribution channels, and market dynamics influencing the drug's availability worldwide.
Manufacturers of Eloxatin (Oxaliplatin)
1. Sanofi:
Sanofi is the original developer and commercializer of Eloxatin. The drug was first introduced by the company in the early 2000s following its clinical development and subsequent approval by regulatory agencies such as the FDA and EMA. Sanofi maintains a significant market share through its global manufacturing and distribution network. The company's manufacturing facilities located primarily in France and the United States produce the active pharmaceutical ingredient (API) and formulate the final product for different markets.
Sanofi actively manages its supply chain to ensure compliance with Good Manufacturing Practice (GMP) standards, given the drug's complex synthesis and rigorous quality controls.
2. Other Licensed Manufacturers:
While Sanofi remains the primary supplier, regulatory approvals in various countries have allowed other pharmaceutical companies to manufacture and distribute oxaliplatin under licensing agreements or through generic pathways. These companies include:
- MannKind Corporation: Engaged in manufacturing under license agreements in certain markets.
- Teva Pharmaceutical Industries: Known for generic chemotherapeutic agents, Teva has received approval for generic oxaliplatin in several jurisdictions, expanding supply options.
- Sandoz (Novartis): Produces generic versions of oxaliplatin, increasing accessibility and reducing costs in markets where their products are approved.
The emergence of generics has contributed to increased competition, offering alternative affordable sources for hospitals and healthcare providers.
Distribution and Supply Chain Considerations
Global Distribution Networks:
Sanofi’s global presence facilitates the widespread distribution of Eloxatin. Its extensive distribution channels cover North America, Europe, Asia, Africa, and Latin America, ensuring regulatory compliance and quality assurance across different regions. These channels include direct sales, third-party logistics providers, and regional distributors.
Regulatory Approvals and Market Access:
Eloxatin's approval status varies across countries, influencing supply volumes and licensing arrangements. The drug has received market authorization from agencies such as the FDA (United States), EMA (European Union), PMDA (Japan), and CFDA (China). However, regulatory barriers in certain jurisdictions can restrict importation or local manufacturing, impacting supply continuity.
Manufacturing Challenges and Risks:
The complex synthesis of oxaliplatin involves sensitive processes, including handling platinum compounds, which necessitates specialized facilities. Manufacturing disruptions—due to regulatory issues, quality concerns, or raw material shortages—can impair global supply. Sanofi has invested in capacity expansions and quality improvements to mitigate such risks.
Impact of Patent and Exclusivity Status:
Sanofi held the primary patent and regulatory exclusivity for Eloxatin globally for years. The expiration of patents in various jurisdictions, notably in the United States (2018) and Europe (2015), has facilitated generic entry, significantly impacting supply dynamics by introducing multiple manufacturers.
Market Dynamics and Key Suppliers
Emerging Competition and Generics:
Post-patent expiration, multiple generic manufacturers have entered the market, often manufacturing under strict licensing agreements or through generic approvals via the Abbreviated New Drug Application (ANDA) pathway (United States). This proliferation has led to increased supply, competitive pricing, and broader regional access.
Supply Chain Challenges:
Despite the entry of generics, supply issues persist due to manufacturing complexities, raw material shortages (notably platinum and other reagents), and geopolitical factors affecting regional distribution. Quality assurance remains critical, especially for oncology drugs with narrow therapeutic windows.
Market Trends:
- Expansion of manufacturing capacity by generics companies has aimed to meet global demand.
- Regional manufacturing hubs have emerged in Asia, particularly India and China, to serve local markets effectively.
- Regulatory harmonization efforts aim to streamline approvals and facilitate swift market entry for new manufacturers.
| Major Suppliers Snapshot: | Supplier | Market Presence | Key Markets | Remarks |
|---|---|---|---|---|
| Sanofi | Original patented producer | Global | Largest market share, established manufacturing | |
| Teva | Leading generic competitor | North America, Europe, Asia | Significant generic volume | |
| Sandoz | Generic innovator | Global | Competitive pricing | |
| Others (e.g., Cadila, Hetero, Sun Pharma) | Regional producers | India, Asia, emerging markets | Increasing regional supply capacity |
Future Outlook and Strategic Considerations
Supply Chain Resilience:
Pharmaceutical companies and health authorities should focus on diversifying suppliers, establishing regional manufacturing hubs, and securing raw material sources. Collaboration between brand-name and generic manufacturers can mitigate shortages during periods of increased demand or manufacturing disruptions.
Regulatory and Patent Landscape:
While patent expiries catalyzed increased competition, ongoing patent litigation and data exclusivity periods may influence market entry timelines for new suppliers. Staying abreast of evolving regulatory policies is essential for market participants.
Innovation and Alternative Therapies:
Development of non-platinum-based chemotherapies and targeted therapies could influence the long-term demand dynamics for Eloxatin. Companies should monitor these trends to adapt supply strategies accordingly.
Key Takeaways
- Sanofi remains the primary manufacturer of Eloxatin (oxaliplatin), with a robust global supply network.
- Generic manufacturers, including Teva and Sandoz, significantly contribute to market supply following patent expirations, increasing accessibility.
- Supply chain resilience depends on diversified manufacturing, raw material sourcing, and regulatory cooperation.
- Regional manufacturing hubs in Asia bolster local supply, reducing dependency on Western producers.
- Market competition and regulatory changes shape the future landscape, necessitating proactive strategic planning by stakeholders.
FAQs
1. Who are the leading global suppliers of Eloxatin?
Sanofi remains the dominant manufacturer, with significant contributions from generic companies like Teva and Sandoz following patent expiries, ensuring competitive supply globally.
2. Are there regional differences in Eloxatin manufacturing?
Yes. While Sanofi produces globally in manufacturing hubs in Europe and North America, regional generics manufacturers in India and China supply local and emerging markets, improving availability and affordability.
3. What impact did patent expiration have on Eloxatin supply?
Patent expirations facilitated the entry of multiple generic manufacturers, increasing supply volume, lowering prices, and expanding access in various regions.
4. What are the main supply risks for Eloxatin?
Manufacturing complexities, raw material shortages (notably platinum salts), regulatory barriers, and geopolitical factors can disrupt supply chains.
5. How might future regulatory changes affect Eloxatin supply?
Harmonized approval processes, patent litigations, and evolving drug safety standards will influence new manufacturer entry, market exclusivity periods, and overall supply stability.
Sources:
[1] Sanofi official website, "Eloxatin Product Information," 2023.
[2] U.S. Food and Drug Administration, ANDA approvals database, 2023.
[3] European Medicines Agency, "Eloxatin (Oxaliplatin) Summary," 2023.
[4] Market research reports on oncology drug manufacturing, 2022.
[5] GlobalData, "Cancer Treatment Drugs Market Outlook," 2022.
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