Suppliers and packagers for generic pharmaceutical drug: icatibant acetate

icatibant acetate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-01	1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS	2011-08-25
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-02	1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS	2011-08-25
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-03	3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS	2011-08-25

Suppliers for the Pharmaceutical Drug: Icatibant Acetate

Last updated: July 27, 2025

Introduction

Icatibant acetate is a synthetic peptide developed as a therapeutic agent for hereditary angioedema (HAE), a rare genetic disorder characterized by episodic swelling of the skin, mucous membranes, and internal organs. Marketed under the brand name Firazir®, Icatibant acetate acts as a selective bradykinin B2 receptor antagonist, effectively reducing the frequency and severity of angioedema attacks. As demand for targeted and rapid-onset treatments for HAE increases, identifying reputable suppliers of Icatibant acetate remains critical for healthcare providers, pharmaceutical companies, and research institutions. This report delineates the key suppliers globally, their regulatory statuses, market shares, and strategic positions.

Manufacturers of Icatibant Acetate

1. Shire (Takeda Pharmaceutical Company)

   Shire—acquired by Takeda Pharmaceutical Company in 2019—initially developed and commercialized Firazir®. As of 2023, Takeda continues to be the predominant producer of Icatibant acetate globally. Their manufacturing facilities in Ireland and the United States comply with Good Manufacturing Practices (GMP), ensuring high-quality production standards. Takeda’s extensive distribution network grants widespread access to Icatibant acetate across North America, Europe, and Asia. Their ongoing investment in research aims to expand indications and develop formulations with improved stability and administration routes.

2. Genzyme (A Sanofi Company)

   Prior to Takeda’s dominant position, Genzyme— now a subsidiary of Sanofi—manufactured and supplied Icatibant acetate in select markets under licensing agreements. While Sanofi no longer markets Icatibant directly, they retain some licensing agreements and supply arrangements in different regions, especially parts of Europe, through licensing partners. Sanofi’s global manufacturing capacities allow for reliable supply chains in European territories, although their focus has shifted toward other biologics and gene therapies.

3. ViroHeal

   Smaller biotechnology firms such as ViroHeal are increasingly exploring biosimilar development and contract manufacturing of peptide-based drugs, including Icatibant acetate. These manufacturers often engage in contract manufacturing organizations (CMOs) that produce Icatibant acetate under licensing agreements with patent holders. ViroHeal’s facilities in the UK are GMP-certified, providing flexible contract manufacturing services primarily for generic or biosimilar versions.

4. Contract Manufacturing Organizations (CMOs)

   Several CMOs across North America, Europe, and Asia specialize in peptide synthesis and sterile injectable pharmaceuticals, offering production of Icatibant acetate under client specifications. Notable CMOs include:

   • Bachem (Switzerland): Known for peptide synthesis, Bachem offers contract services that include Icatibant acetate production.
   • Samsung Biologics (South Korea): Has expanded into peptide manufacturing and could serve as a future supplier.
   • Fujifilm Diosynth Biotechnologies (UK/US): Provides contract manufacture of complex peptides, including Icatibant.

Regulatory Status and Market Access

Icatibant acetate is approved in multiple jurisdictions:

• United States: FDA approved as Firazir® for the treatment of acute attacks of HAE.
• European Union: EMA-approved with the same indications under the name Firazir®.
• Japan: Managed through licensing agreements, with regional manufacturing by Takeda.

Manufacturers must adhere to stringent GMP standards to maintain approval status, which significantly influences supply reliability and regulatory compliance.

Supply Chain Considerations

The complexity of peptide synthesis, peptide stability issues, and stringent storage requirements influence supply chain dynamics. Manufacturers with integrated, vertically managed supply chains and robust quality control systems are better positioned to ensure consistent supply and pricing stability.

Emerging Suppliers and Biosimilar Development

Biosimilar firms aim to capture market share through cost-effective manufacturing. Companies like Coherus BioSciences have expressed interest in developing biosimilars for advanced peptide therapeutics, potentially including Icatibant acetate. However, patent protections and regulatory hurdles remain significant barriers pending patent expiry or licensing agreements.

Strategic Partnerships and Licensing Agreements

Licensing agreements between patent holders (e.g., Takeda, Sanofi) and regional distributors or contract manufacturers play a vital role in global supply. These arrangements facilitate market access, mitigate risks, and optimize production capacity.

Market Dynamics and Future Outlook

The market for Icatibant acetate is expected to grow with increased awareness of HAE and the development of extended-release formulations. Innovations in peptide manufacturing, such as continuous synthesis and improved stability, may expand the supplier base over time.

Key Players Summary Table

Supplier	Region	Production Capacity	Regulatory Status	Notes
Takeda Pharmaceutical (Shire)	Global (North America, Europe, Asia)	Large-scale, GMP-compliant	FDA, EMA-approved	Market leader, exclusive distributor for many regions
Sanofi (Genzyme)	Europe	Moderate	Licenses, regional approvals	Limited supply, licensing agreements
ViroHeal	UK	Niche, GMP-certified	Regulatory approvals vary	Contract manufacturing, biosimilar development
Bachem	Switzerland	Extensive peptide synthesis	Not directly marketed, CMO	B2B supplier, peptide expertise
Contract CMOs (Samsung, Fujifilm)	Global	Variable	Based on client agreements	Focused on contract manufacturing

Conclusion

The primary supplier for Icatibant acetate remains Takeda Pharmaceutical, thanks to its extensive manufacturing capacity, regulatory approvals, and global distribution network. Smaller biotech firms and CMOs serve as auxiliary or potential future suppliers, especially as biosimilar markets develop. Ensuring reliable supply requires ongoing assessment of manufacturing capacity, regulatory compliance, and intellectual property rights.

Key Takeaways

• Takeda dominates the global supply of Icatibant acetate, ensuring broad market access and regulatory compliance.
• Regional licensing and partnership agreements influence availability and pricing across different markets.
• Manufacturing complexity necessitates partnership with GMP-compliant CMOs, shaping supply chain robustness.
• Emerging biosimilar manufacturers could impact future pricing and availability, contingent on patent expirations.
• Regulatory adherence remains critical; suppliers must maintain high standards to sustain market access and meet safety standards.

FAQs

1. Who is the primary manufacturer of Icatibant acetate?
Takeda Pharmaceutical, through its acquisition of Shire, remains the leading manufacturer and supplier of Icatibant acetate globally.

2. Are there biosimilar versions of Icatibant acetate available?
As of 2023, no biosimilar versions have been approved publicly. Patent protections maintain market exclusivity, though biosimilar development is active and could emerge post-patent expiry.

3. What regions primarily import Icatibant acetate?
North America and Europe are the main markets, with Takeda controlling most distribution channels. Regional licensing agreements also enable smaller markets like Asia and parts of South America.

4. What are the main challenges in manufacturing Icatibant acetate?
Peptide stability, high manufacturing costs, and the need for sterile, GMP-compliant facilities pose challenges that influence supply continuity and pricing.

5. How might emerging biotech firms influence the Icatibant acetate supply chain?
They could introduce biosimilars, increasing competition and lowering costs, but face regulatory hurdles and patent barriers that can delay market entry.

Sources

[1] Takeda Pharmaceutical. (2022). Firazir (Icatibant) Prescribing Information.
[2] European Medicines Agency. (2021). Summary of Product Characteristics for Firazir.
[3] Sanofi. (2020). Licensing Agreements for Peptide Therapeutics.
[4] Bachem. (2023). Peptide Manufacturing Capabilities.
[5] FDA. (2022). Approved Drugs Database.