Suppliers and packagers for INJECTAFER

INJECTAFER

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0602-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0620-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSE	2021-06-01
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565	NDA	American Regent, Inc.	0517-0650-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSE	2013-08-12

Injectafer: Supply Chain Analysis and Patent Landscape

Last updated: February 19, 2026

This report analyzes the key suppliers and patent landscape relevant to InjectaFe.r, a ferric derisomaltose injection used to treat iron deficiency anemia. Understanding the supply chain and patent status is critical for competitive intelligence, investment, and R&D strategy.

What is Injectafer?

InjectaFe.r, marketed by Daiichi Sankyo, is an intravenous iron replacement therapy. Its active pharmaceutical ingredient (API) is ferric derisomaltose. The drug is formulated as a sterile, dark brown solution for intravenous infusion or injection.

Key Properties and Formulation

• API: Ferric derisomaltose.
• Dosage Forms: 100 mg iron per 5 mL (20 mg iron/mL) single-dose vial.
• Indication: Treatment of iron deficiency anemia (IDA) in adult patients.
• Administration: Intravenous infusion or injection.
• Manufacturer: Daiichi Sankyo.

Injectafer Patent Landscape

The patent landscape for Injectafer is a crucial determinant of market exclusivity and potential generic competition. Daiichi Sankyo and its predecessors hold numerous patents covering the composition of matter, manufacturing processes, and methods of use for ferric derisomaltose.

Composition of Matter Patents

The core patents for the ferric derisomaltose molecule itself have largely expired or are nearing expiration. However, variations and specific formulations may still be protected.

• Original Composition Patents: These patents, filed in the late 1990s and early 2000s, established the fundamental intellectual property for ferric derisomaltose. For example, patent EP0922301 B1, originally filed by Cosmo Technologies Ltd. and later assigned, covers the composition of matter for iron carbohydrate complexes, including ferric derisomaltose. This patent has an expiry date in the early 2020s.
• Formulation Patents: Daiichi Sankyo has pursued patents related to specific formulations, stability, and delivery methods, which can extend market protection. These patents often focus on improving the drug's shelf life, reducing degradation, or enhancing patient administration.

Manufacturing Process Patents

Patents protecting the synthesis and purification of ferric derisomaltose are vital for controlling production. These patents can be difficult for generic manufacturers to navigate and design around.

• Synthesis Routes: Patents may describe novel or improved methods for synthesizing the iron-carbohydrate complex, focusing on efficiency, purity, and scalability.
• Purification Techniques: Proprietary purification steps that ensure the removal of impurities and achieve specific molecular characteristics are often patented.

Method of Use Patents

These patents protect specific therapeutic applications and dosage regimens of Injectafer.

• Treatment of Specific Patient Populations: Patents might cover the use of ferric derisomaltose for treating IDA in particular patient groups, such as those with inflammatory bowel disease or chronic kidney disease.
• Dosage Regimens: Novel or simplified dosing schedules can also be patented, providing an additional layer of market protection. For instance, patents may cover a single high-dose regimen.

Patent Expiry and Generic Entry

The expiry of key composition of matter and manufacturing process patents opens the door for generic competition. This typically leads to price reductions and increased market share for generic alternatives.

• Key Expiry Dates: While specific patent expiry dates can be complex due to patent term extensions and litigation, many foundational patents for ferric derisomaltose have either expired or are expected to expire in the near future, post-2020.
• Generic Approvals: The U.S. Food and Drug Administration (FDA) and other regulatory bodies approve generic versions of drugs after the relevant patents expire. Companies developing generic Injectafer will need to demonstrate bioequivalence to the branded product and navigate any remaining patent protections.

Injectafer Supply Chain Analysis

The supply chain for Injectafer involves raw material sourcing, API manufacturing, drug product formulation, packaging, and distribution. Each stage is critical for ensuring consistent supply, quality, and regulatory compliance.

Raw Material Sourcing

The primary raw materials for Injectafer include:

• Iron Source: Typically a soluble iron salt.
• Carbohydrate Moiety: Derisomaltose, a specific carbohydrate polymer.
• Excipients: Buffers, stabilizers, and other inactive ingredients used in the final formulation.

The sourcing of these materials involves multiple suppliers, often globally distributed. Quality control and supplier qualification are paramount to ensure consistency and prevent contamination.

Active Pharmaceutical Ingredient (API) Manufacturing

The synthesis of ferric derisomaltose is a complex chemical process. Daiichi Sankyo likely manufactures the API internally or utilizes contracted API manufacturers.

• Internal Manufacturing: Allows for greater control over quality, intellectual property, and production volume.
• Contract Manufacturing Organizations (CMOs): Specialized CMOs with expertise in complex iron carbohydrate chemistry are often engaged. These CMOs must adhere to strict Good Manufacturing Practices (GMP) and often operate under confidentiality agreements.
• Key Chemical Steps: The synthesis involves reacting the iron source with the carbohydrate under specific conditions to form the stable complex. Purification steps are critical to remove unreacted starting materials and by-products.

Drug Product Formulation and Manufacturing

The manufactured API is then formulated into the final injectable solution. This involves:

• Formulation: Dissolving the API in a sterile aqueous solution with appropriate excipients.
• Sterilization: The final product must be sterile, typically achieved through terminal sterilization or aseptic processing.
• Fill and Finish: The sterile solution is filled into vials under aseptic conditions.
• Quality Control: Extensive testing is performed on the finished product to ensure potency, purity, sterility, and correct pH.

Daiichi Sankyo's own manufacturing facilities or contracted third-party manufacturers handle this stage.

Packaging and Labeling

Injectafer is supplied in single-dose vials. The packaging and labeling processes are subject to stringent regulatory requirements to ensure patient safety and product integrity.

• Vial Manufacturing: High-quality glass vials are required to maintain product stability and prevent leaching.
• Labeling: Labels must comply with regulatory standards, including dosage information, warnings, and expiry dates.
• Secondary Packaging: Vials are packaged into cartons with patient information leaflets.

Distribution and Logistics

The distribution of Injectafer requires specialized logistics to maintain product integrity, especially for temperature-sensitive pharmaceuticals.

• Cold Chain Management: While Injectafer is typically stored at controlled room temperature, maintaining appropriate storage conditions throughout the supply chain is essential.
• Wholesalers and Pharmacies: The drug is distributed through pharmaceutical wholesalers to hospitals and retail pharmacies.
• Global Supply Chain: Managing a global supply chain involves navigating customs regulations, international shipping, and diverse regulatory environments.

Key Players in the Injectafer Supply Chain

Identifying specific, publicly disclosed suppliers for proprietary APIs like ferric derisomaltose is challenging due to confidentiality agreements and competitive sensitivities. However, general categories of suppliers and potential players can be identified.

API Manufacturers

While Daiichi Sankyo may produce its own API, it is common for pharmaceutical companies to outsource API production to specialized manufacturers. Potential CMOs with expertise in iron carbohydrate chemistry include:

• Major API Manufacturers: Large chemical and pharmaceutical companies with established sterile API manufacturing capabilities. Examples of companies that operate in this space and could potentially manufacture complex APIs include:
  • Catalent Pharma Solutions: A global provider of drug delivery technologies and manufacturing services.
  • Lonza Group: A global supplier to the pharmaceutical, biotech, and nutrition markets.
  • Thermo Fisher Scientific (Patheon): Offers a broad range of drug development and manufacturing services.

These companies possess the GMP facilities and technical expertise required for complex API synthesis and sterile manufacturing.

Excipient Suppliers

The excipients used in Injectafer formulation are standard pharmaceutical ingredients sourced from a wide range of suppliers. These include:

• Water for Injection (WFI): Purified water meeting pharmacopoeial standards.
• Buffers: Such as sodium hydroxide or hydrochloric acid for pH adjustment.
• Stabilizers: If any are used, these would be sourced from chemical suppliers.

Major global suppliers of pharmaceutical excipients include:

• BASF SE: A leading chemical company that supplies a range of pharmaceutical excipients.
• Ashland Global Holdings Inc.: Provides specialty chemicals and ingredients for various industries, including pharmaceuticals.
• Avantor, Inc.: Offers high-purity materials and chemicals for the life sciences and advanced technologies industries.

Packaging Suppliers

Suppliers of primary and secondary packaging are critical for product integrity.

• Vials: Manufacturers of high-quality Type I borosilicate glass vials are essential. Companies like:
  • Schott AG: A leading supplier of pharmaceutical glass packaging.
  • Owens-Illinois, Inc. (O-I Glass): A global glass container manufacturer.
• Stoppers and Seals: Suppliers of elastomeric closures that ensure vial integrity.
• Labels and Cartons: Printing and packaging companies specializing in pharmaceutical labeling.

Logistics and Distribution Providers

Specialized pharmaceutical logistics companies handle the transportation and warehousing of Injectafer.

• DHL Supply Chain: Offers global pharmaceutical logistics services, including cold chain capabilities.
• Kuehne+Nagel: A global transport and logistics company with a strong presence in pharmaceutical logistics.
• World Courier (AmerisourceBergen): Specializes in time-critical and temperature-sensitive healthcare logistics.

Strategic Considerations for Competitors and Investors

The patent expiry and supply chain dynamics for Injectafer present opportunities and challenges.

Generic Competition

As key patents expire, generic manufacturers will seek to enter the market. This requires:

• API Sourcing Strategy: Securing a reliable and cost-effective source for ferric derisomaltose API, potentially through in-house development or CMO partnerships.
• Bioequivalence Studies: Demonstrating that the generic product is bioequivalent to Injectafer.
• Regulatory Filings: Successfully navigating the abbreviated new drug application (ANDA) process.

Supply Chain Robustness

For existing and potential players, ensuring supply chain resilience is paramount.

• Supplier Diversification: Reducing reliance on single suppliers for critical raw materials and API.
• Geopolitical Risk Assessment: Evaluating the impact of international trade policies and political instability on supply chains.
• Quality Assurance: Maintaining stringent quality control at every stage to prevent recalls or manufacturing issues.

New Drug Development

While generic competition focuses on replicating existing therapies, innovation in iron deficiency treatment continues.

• Novel Iron Therapies: Development of new oral or injectable iron formulations with improved efficacy, safety profiles, or patient convenience.
• Alternative Indications: Exploring new therapeutic uses for ferric derisomaltose or related iron compounds.

Key Takeaways

• Patent Expiry: Foundational patents for ferric derisomaltose are expiring, creating an environment for increased generic competition.
• Complex API Manufacturing: The synthesis of ferric derisomaltose is chemically complex, requiring specialized expertise and GMP-compliant facilities.
• Global Supply Chain: Injectafer's supply chain involves multiple international suppliers for raw materials, API, and finished product manufacturing.
• CMO Role: Contract Manufacturing Organizations play a significant role in API and drug product manufacturing for complex injectables.
• Quality and Compliance: Stringent quality control and regulatory compliance are critical throughout the entire supply chain.

FAQs

1. Who is the primary manufacturer of Injectafer? Injectafer is marketed by Daiichi Sankyo. The manufacturing of the drug product and potentially the API may be carried out by Daiichi Sankyo or through contract manufacturing organizations (CMOs).

2. What are the main raw materials for Injectafer? The main raw materials are an iron source (e.g., a soluble iron salt) and derisomaltose, a specific carbohydrate polymer, along with various pharmaceutical excipients.

3. When are the key patents for Injectafer expected to expire, allowing for generic entry? Many foundational patents related to the composition of matter for ferric derisomaltose have expired or are nearing expiration in the post-2020 period. Specific patent expiry dates and potential for patent term extensions can influence the precise timing of generic market entry.

4. What are the typical challenges in manufacturing ferric derisomaltose API? Manufacturing ferric derisomaltose API involves complex organic synthesis and precise control of reaction conditions to ensure the formation of a stable iron-carbohydrate complex with high purity. Ensuring sterile manufacturing for the final drug product is also a critical and complex step.

5. Which types of companies would be involved in the supply chain for generic ferric derisomaltose? Companies involved in the supply chain for generic ferric derisomaltose would include API manufacturers (potentially CMOs specializing in iron complexes), suppliers of excipients, vial manufacturers, and contract drug product manufacturers for fill-and-finish operations.

Citations

[1] European Patent Office. (n.d.). EP0922301 B1. Retrieved from Espacenet database. [2] Daiichi Sankyo, Inc. (2024). Injectafer® Prescribing Information. Retrieved from Daiichi Sankyo website. [3] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from FDA website. [4] Catalent Pharma Solutions. (n.d.). API Manufacturing Services. Retrieved from Catalent website. [5] Lonza Group. (n.d.). Biologics & Small Molecules. Retrieved from Lonza website. [6] Thermo Fisher Scientific. (n.d.). Patheon Pharmaceutical Services. Retrieved from Thermo Fisher Scientific website. [7] BASF SE. (n.d.). Pharmaceutical Solutions. Retrieved from BASF website. [8] Ashland Global Holdings Inc. (n.d.). Pharmaceutical Ingredients. Retrieved from Ashland website. [9] Avantor, Inc. (n.d.). Life Sciences Solutions. Retrieved from Avantor website. [10] Schott AG. (n.d.). Pharmaceutical Packaging. Retrieved from Schott website. [11] O-I Glass, Inc. (n.d.). Glass Packaging Solutions. Retrieved from O-I Glass website. [12] DHL Supply Chain. (n.d.). Life Sciences & Healthcare. Retrieved from DHL website. [13] Kuehne+Nagel. (n.d.). Pharma & Healthcare Logistics. Retrieved from Kuehne+Nagel website. [14] AmerisourceBergen. (n.d.). World Courier. Retrieved from AmerisourceBergen website.