Suppliers and packagers for TAXOTERE

TAXOTERE

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	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1020-01	1 VIAL, GLASS in 1 CARTON (0955-1020-01) / 1 mL in 1 VIAL, GLASS	2010-10-21
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1021-04	1 VIAL, GLASS in 1 CARTON (0955-1021-04) / 4 mL in 1 VIAL, GLASS	2010-10-21
Sanofi Aventis Us	TAXOTERE	docetaxel	INJECTABLE;INJECTION	020449	NDA AUTHORIZED GENERIC	Sanofi-Aventis U.S. LLC	0955-1022-08	1 VIAL, GLASS in 1 CARTON (0955-1022-08) / 8 mL in 1 VIAL, GLASS	2016-10-23

Suppliers for the Pharmaceutical Drug: TAXOTERE

Last updated: July 29, 2025

Introduction

TAXOTERE, the brand name for docetaxel, is a chemotherapeutic agent widely used in oncology treatments, including breast, lung, prostate, and gastric cancers. As a critical component in cancer therapy regimens, the global supply chain for TAXOTERE is vital for ensuring continuous patient access. Understanding the landscape of its suppliers—comprising patent holders, manufacturing entities, and authorized distributors—is essential for pharmaceutical stakeholders, healthcare providers, and regulatory agencies aiming to navigate market dynamics, assess supply security, and mitigate risks associated with shortages or counterfeit products.

This article explores the key suppliers of TAXOTERE, detailing the manufacturing landscape, licensing arrangements, regional distribution networks, and market players. It emphasizes the importance of supply chain integrity within the highly regulated pharmaceutical ecosystem.

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Manufacturers and Patent Holders

Sanofi (Sanofi-Aventis)

Sanofi, based in France, is the primary patent holder and original manufacturer of TAXOTERE. The company introduced docetaxel to the market in the early 1990s. Sanofi’s manufacturing facilities are located across Europe, North America, and Asia, enabling a broad supply network. Sanofi maintains strict control over procurement, quality assurance, and distribution channels for the brand-name drug, making it a significant supplier globally.

Generic Manufacturers

Following the expiration of patent exclusivity in many jurisdictions, numerous generic pharmaceutical companies began producing docetaxel, often under different brand names or as bulk active pharmaceutical ingredient (API). These manufacturers supply the market with biosimilar or non-branded versions of the drug.

Major generic suppliers include:

• Lek Pharmaceuticals (Slovenia): An established producer of taxane-based chemotherapeutic agents, including docetaxel.

• Huadong Medicine (China): Manufacturing and distributing generic docetaxel, primarily in the Asian markets.

• Jiangsu Hengrui Medicine (China): A prominent producer of oncologic generics, including docetaxel.

• Fresenius Kabi (Germany): Supplies generic oncology injectables, including docetaxel formulations.

• Teva Pharmaceuticals (Israel): Produces generic chemotherapeutic agents with regional distribution channels.

Emerging biosimilar and generic manufacturers are expanding their presence, especially in Asian markets, to meet rising global demand.

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Regulatory Approvals and Licensing Dynamics

The distribution and supply of TAXOTERE are subject to regional regulatory approvals from agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. Original manufacturer Sanofi has exclusive marketing rights in some regions, while licensing agreements in others facilitate generic manufacturing.

Key licensing and approval pathways include:

• Patent expiration: Typically occurs 10-12 years post-launch, allowing generics to enter markets.

• Regulatory filings: Generics require bioequivalence testing and approval before commercial distribution.

• Authorized generics: Sanofi has historically authorized some generics in select markets to meet demand and comply with regulations.

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Regional Supply Dynamics

North America

Sanofi maintains dominant market share with its original patent-protected TAXOTERE product. However, multiple generics are available following patent expiry, ensuring a more competitive and diversified supply chain.

Europe

Sanofi's manufacturing facilities primarily serve Europe, with several licensed generics operating under strict regulatory compliance, ensuring steady supply.

Asia-Pacific

A substantial portion of docetaxel is produced domestically by regional companies such as Jiangsu Hengrui and Huadong Medicine. These companies have leveraged local manufacturing advantages to supply both regional and international markets.

Emerging Markets

In regions with less developed regulatory frameworks, local manufacturers often fill supply gaps, sometimes raising concerns about quality and authenticity. Global efforts aim to reinforce quality standards and supply chain transparency.

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Supply Chain Risks and Mitigation

The reliance on a few key suppliers poses supply risks, including manufacturing disruptions, regulatory challenges, or counterfeit infiltration. Sanofi’s centralized production model enhances control but limits flexibility. Conversely, the proliferation of generics introduces variability in quality assurance.

Pharmaceutical companies and healthcare providers mitigate risks through:

• Supplier diversification: Engaging multiple approved manufacturers.

• Inventory management: Maintaining strategic stockpiles.

• Regulatory oversight: Ensuring suppliers adhere to Good Manufacturing Practices (GMP).

• Supply chain audits: Conducting regular inspections and compliance checks.

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Market Trends and Future Outlook

The market for TAXOTERE and its generics is evolving with technological innovations such as biosimilars and combinatorial therapies. The emergence of biosimilar docetaxel products—aimed at reducing costs—could reshape supply dynamics, pending regulatory approval and market acceptance.

Sanofi's strategic decisions concerning patent protections and licensing agreements will significantly influence supply stability. Meanwhile, regional manufacturing capacity expansions, particularly in Asia, support global accessibility.

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Key Players Summary

Company	Role	Region	Notes
Sanofi	Original Patent Holder & Manufacturer	Global	Maintains core supply with authorized generics
Jiangsu Hengrui	Generics & Biosimilars	China	Growing regional and international presence
Huadong Medicine	Generics	China	Significant Asian market player
Fresenius Kabi	Generics	Europe, Global	Supplies oncology injectables globally
Teva Pharmaceuticals	Generics	Multiple regions	Wide distribution network

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Conclusion

The supply landscape for TAXOTERE is diverse, with Sanofi as the principal original manufacturer and a growing roster of regional and international generic producers. The transition of patents and approvals from Sanofi to generics has increased supply options, but also introduced complexities pertaining to quality assurance, regulatory compliance, and supply chain robustness.

Manufacturers and stakeholders must navigate evolving regulatory environments, regional market demands, and supply risks. Strategic diversification of suppliers, reinforced quality controls, and proactive inventory policies are essential to ensure uninterrupted access to this vital oncologic agent.

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Key Takeaways

• Sanofi remains the primary original supplier of TAXOTERE, controlling core manufacturing and distribution rights.
• Post-patent expiry, multiple generics and biosimilars have entered the market, increasing supply options but necessitating vigilant quality oversight.
• Regional manufacturing hubs, especially in China and Europe, have expanded production capacities, supporting global availability.
• Supply chain risks include manufacturing disruptions, regulatory variations, and counterfeit threats; diversification and compliance are crucial mitigation strategies.
• Future market developments may include biosimilar innovations and strategic licensing, shaping the supply landscape and affordability.

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FAQs

1. Who are the main suppliers of TAXOTEEER internationally?
   Sanofi is the original manufacturer, with major generic producers including Jiangsu Hengrui, Huadong Medicine, and Fresenius Kabi, among others.

2. What factors influence the availability of TAXOTEEER in different regions?
   Patent status, regulatory approvals, manufacturing capacity, regional demand, and licensing agreements impact supply in each market.

3. Are there quality concerns associated with generic docetaxel?
   Quality varies among manufacturers; regulatory agencies enforce GMP standards. Stakeholders should verify supplier certification and adherence to quality standards.

4. How might patent expirations affect the supply chain?
   Patent expiration opens the market for generics, increasing supply and potentially reducing costs, but requires rigorous supply chain monitoring to ensure quality.

5. What are the emerging trends in the TAXOTERE supply ecosystem?
   Development of biosimilar products, regional manufacturing expansion, and strategic licensing are shaping future supply dynamics, emphasizing cost-efficiency and access.

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References

1. [1] Sanofi. (2022). Annual Report and Product Portfolio.
2. [2] European Medicines Agency. (2023). Marketing authorization of docetaxel.
3. [3] FDA. (2022). Guidance for Industry: Biosimilar Product Development.
4. [4] Market Research Future. (2021). Global Oncology Drug Market Analysis.
5. [5] World Health Organization. (2020). Quality Assurance of Pharmaceuticals.