Suppliers and packagers for rapivab

rapivab

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426	NDA	BioCryst Pharmaceuticals, Inc.	72769-181-03	3 VIAL, GLASS in 1 CARTON (72769-181-03) / 20 mL in 1 VIAL, GLASS (72769-181-01)	2014-12-20

Suppliers for the Pharmaceutical Drug: Rapivab (Peramivir)

Last updated: July 27, 2025

Introduction

Rapivab (peramivir) is an intravenous antiviral medication used primarily for the treatment of influenza. It belongs to the class of neuraminidase inhibitors, which inhibit the neuraminidase enzyme on the surface of influenza viruses, thereby preventing virus release from infected cells and reducing the severity and duration of illness. Approved by the U.S. Food and Drug Administration (FDA) in 2014, Rapivab is a critical option for hospitalized patients or those unable to take oral medications. Understanding the landscape of suppliers involved in the production and distribution of Rapivab is vital for pharmaceutical companies, healthcare providers, and policymakers.

Manufacturers of Peramivir: The Core Suppliers

1. BioCryst Pharmaceuticals

Overview:
BioCryst Pharmaceuticals, a U.S.-based biotechnology firm, developed Rapivab (peramivir) and holds the original manufacturing rights. The company pioneered the synthesis and clinical development of peramivir, aiming to combat influenza and other viral infections.

Manufacturing Role:
BioCryst is the primary producer of the API (Active Pharmaceutical Ingredient) for Rapivab. Their manufacturing facilities are situated in the United States, complying with Good Manufacturing Practices (GMP). They supply the end product to several distribution partners and licensees.

Partnerships and Licensing:
In 2014, BioCryst licensed the commercialization rights to The Medicines Company (later acquired by Novartis), which was responsible for marketing and distribution in certain territories [1].

2. The Medicines Company / Novartis

Overview:
The Medicines Company, acquired by Novartis in 2020, was responsible for manufacturing and commercializing Rapivab in the United States and select global markets.

Manufacturing Operations:
Post-acquisition, Novartis continued to leverage existing manufacturing infrastructure and expanded its capacity for Rapivab supply, ensuring consistency in production and distribution.

Global Reach:
Novartis’ extensive global manufacturing network facilitated the distribution of Rapivab worldwide, with local regulatory approvals in various countries.

3. Teva Pharmaceuticals

Emerging Role:
Though primarily known for generic drugs, Teva has shown interest in developing and supplying antiviral agents. While Teva does not currently manufacture Rapivab directly, it potentially offers alternative suppliers for similar antiviral compounds, or may enter the market in generic formulations once patent protections expire.

4. Contract Manufacturing Organizations (CMOs)

Overview:
As the demand for influenza treatment rises globally, several CMOs with expertise in sterile, intravenous drug production have emerged as auxiliary suppliers of generic or biosimilar peramivir products.

Examples:

• Catalent Pharma Solutions
• Recipharm
• Lonza

These companies can undertake large-scale sterile manufacturing, ensuring supply resilience, especially during influenza pandemics [2].

Global Supply Chain Dynamics

Patent and Regulatory Considerations

Peramivir’s patent life greatly influences supplier dynamics. The original patents held by BioCryst and licensing agreements restrict manufacturing to licensed producers. Once patents expire, generic manufacturers could enter the market, increasing supply and lowering costs.

Import and Local Production

In regions outside the U.S., local pharmaceutical companies may import the licensed product or develop biosimilar versions under license agreements, expanding suppliers' base.

Global Market and Distribution Channels

Major markets such as North America, Europe, and Asia rely on a combination of direct manufacturing by patent holders and licensed distributors. These distribution channels involve wholesalers, hospital formularies, and government procurement agencies.

Supply Chain Risks

Potential disruptions include regulatory delays, manufacturing issues, geopolitical conflicts, or demand surges during influenza epidemics or pandemics, emphasizing the need for diversified suppliers.

Key Factors Influencing Supplier Selection

• Regulatory compliance and approvals
• Manufacturing capacity and quality standards
• Cost competitiveness
• Supply chain resilience
• Patents and licensing agreements

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Conclusion

The primary supplier of Rapivab (peramivir) remains BioCryst Pharmaceuticals, with manufacturing and licensing agreements facilitating global distribution largely managed by The Medicines Company (now part of Novartis). While direct manufacturing is concentrated among a few entities post-approval, the landscape is poised for diversification and expansion, particularly after patent expiration. Companies seeking to enter or expand within the peramivir supply chain should focus on establishing robust licensing, manufacturing, and distribution partnerships, considering the importance of regulatory compliance and supply chain robustness.

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Key Takeaways

• BioCryst Pharmaceuticals is the original manufacturer of Rapivab’s API, holding core intellectual property rights.
• Novartis, via its acquisition of The Medicines Company, has managed global manufacturing and distribution, ensuring extensive reach.
• Contract manufacturing organizations (CMOs) like Catalent and Recipharm are pivotal in supporting large-scale sterile production, especially for generic or biosimilar versions.
• Patent expirations will catalyze the entry of generic manufacturers, broadening the supplier base and reducing costs.
• Supply chain resilience amid global health emergencies depends on diversified manufacturing and distribution partnerships, regulatory stability, and quality assurance.

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FAQs

1. Who are the primary manufacturers of peramivir for Rapivab?

BioCryst Pharmaceuticals developed and primarily manufactures the API for Rapivab. Post-licensing and acquisition activities by Novartis have expanded manufacturing and distribution capabilities globally.

2. Are there generic equivalents of Rapivab available currently?

As of now, no approved generics exist; patent protections limit manufacturing by generic firms. This is expected to change once patents expire, opening the market for biosimilar and generic producers.

3. Which regions have the most robust supply chain for Rapivab?

The United States and Europe benefit from direct manufacturing licenses and approvals, supported by regional distributors and hospital procurement systems. Emerging markets depend more on imports and licensing agreements.

4. How do supply chain disruptions impact the availability of Rapivab?

Disruptions can lead to shortages, especially during peak influenza seasons or global pandemics. Diversification of suppliers and maintaining multiple manufacturing sites mitigate risks.

5. What role do contract manufacturers play in the supply of peramivir?

CMOs provide sterile manufacturing services, increase production capacity, and ensure supply continuity, particularly for large-scale or biosimilar production once patents expire.

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References

[1] BioCryst Pharmaceuticals. (2014). FDA approves RAPIVAB for influenza.
[2] MarketWatch. (2021). Pharmaceutical Contract Manufacturing Market Outlook.