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Suppliers and packagers for generic pharmaceutical drug: TECOVIRIMAT
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TECOVIRIMAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Siga Technologies | TPOXX | tecovirimat | SOLUTION;INTRAVENOUS | 214518 | NDA | SIGA Technologies, Inc. | 50072-010-01 | 7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30) | 2022-05-31 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Tecovirimat
Introduction
Tecovirimat, also known by its development code ST-246, is an antiviral medication primarily designed for the treatment of orthopoxvirus infections, including smallpox, monkeypox, and cowpox. As an approved or investigational drug, its supply chain involves multiple manufacturers, suppliers, and distributors across the globe. Understanding the landscape of suppliers for tecovirimat is integral for stakeholders—public health agencies, pharmaceutical companies, healthcare providers, and governments—seeking to ensure drug availability, secure procurement channels, and develop strategic stockpiles. This article delineates the key suppliers, manufacturing dynamics, and logistical considerations surrounding teovirimat.
Regulatory Landscape and Commercial Availability
Tecovirimat was developed by SIGA Technologies Inc., a biotechnology firm specializing in antiviral drugs. The U.S. Food and Drug Administration (FDA) approved tecovirimat in 2018 under the Brand Name TPOXX for the treatment of smallpox in adults and children (above 13 kg). The approval mandated that SIGA supply the drug to the U.S. government under a licensing agreement, including through government-contracted manufacturing facilities, to ensure readiness for biothreat emergencies.
Internationally, tecovirimat's availability hinges on regulatory approvals, licensing agreements, and manufacturing capacity. The European Medicines Agency (EMA) granted orphan drug designation to tecovirimat but has yet to approve its commercial use across the EU. As a result, supply chains in different regions vary, with some countries relying on imports or stockpiling initiatives.
Manufacturers and Supply Chain Actors
Primary Manufacturer: SIGA Technologies Inc.
- Core Role: SIGA remains the exclusive commercial manufacturer of tecovirimat in the United States. The company's facilities in New York and other locations are approved by the FDA under Good Manufacturing Practice (GMP) standards.
- Production Capacity: While SIGA has scaled up manufacturing, the precise output capacity remains proprietary. The company's strategic partnerships aim to bolster supply, especially in emergency scenarios.
- Supply Agreements: The U.S. government holds a contract with SIGA for a guaranteed supply, supplemented by distribution channels that include the Strategic National Stockpile (SNS).
Contract Manufacturing Organizations (CMOs)
To meet global demand and diversify supply sources, SIGA has engaged third-party CMOs for manufacturing assistance. These organizations are responsible for:
- Large-Scale Production: Ensuring consistent GMP-compliant manufacturing.
- Quality Control: Maintaining stringent quality standards in line with FDA or EMA guidelines.
- Logistics: Managing distribution logistics tied to governmental or private sector needs.
Global Suppliers and Licensing Partners
As of now, there are limited licensed manufacturers outside of SIGA. However, efforts to expand manufacturing capacity involve licensing agreements with emerging producers in regions such as Europe and Asia.
- MediGene AG (Germany): Reported interest in licensing or manufacturing partnerships, though details remain undefined.
- Chinese manufacturers: Some Chinese biotech firms have expressed interest in producing tecovirimat under license, especially in contexts related to the recent resurgence of monkeypox.
Importers and Distributors
In countries without direct manufacturing facilities or approval, imports are facilitated through:
- Government Contracted Distributors: These entities often include military logistics services, public health agencies, or specialized pharmaceutical distributors.
- Private Sector Pharmacists: In some cases, high-containment pharmacies can source the drug through government channels or import licenses.
Supply Chain Challenges and Considerations
Limited Manufacturing Capacity
Given the rarity of authorized usage—primarily for biothreat preparedness—the manufacturing capacity for tecovirimat is limited relative to common pharmaceuticals. The complex synthesis of the antiviral involves specialized pharmaceutical chemistry and stringent quality controls, constraining rapid scaling.
Regulatory Bottlenecks and Licensing
Expanding supply involves navigating regulatory approvals across jurisdictions, which can delay licensing and manufacturing scale-up. Efforts to license production in other countries face challenges, such as intellectual property rights and technical know-how transfer.
Global Stockpile and Emergency Preparedness
The U.S. stockpile incorporates tecovirimat as a staple agent for biothreat response. The variability in global stockpiling strategies influences supply stability, with ongoing efforts to establish additional manufacturing partnerships to mitigate shortages.
Potential for Generic Production
Patent protections and licensing restrictions currently limit generic production. However, once patents expire or licensing agreements evolve, generic manufacturers could significantly increase supply and reduce costs.
Emerging Developments and Future Outlook
- Scale-Up Initiatives: SIGA and partners are pursuing initiatives to expand manufacturing capacity to meet anticipated demand, especially in light of recent monkeypox outbreaks, which have heightened global awareness of orthopoxvirus threats.
- Alternate Formulations: Research into alternative formulations, such as oral and injectable forms, may influence supply chain dynamics.
- International Collaboration: The WHO and various governments are exploring collaborative manufacturing arrangements, including technology transfer to increase access in low- and middle-income countries.
Key Takeaways
- Limited but Strategic Supply: Currently, SIGA remains the primary supplier of tecovirimat, supported by government contracts and partnerships with manufacturing organizations.
- Regulatory and Logistical Bottlenecks: Growth in supply capacity hinges on regulatory approvals in additional jurisdictions and expanding manufacturing partnerships.
- Global Supply Security: Diversification of manufacturing sources through licensing agreements is paramount to ensure global availability, especially amid emergent orthopoxvirus threats.
- Preparedness Focus: Governments should prioritize procurement strategies, stockpiling, and expanding manufacturing capacity to safeguard against biothreats.
- Innovation and Licensing Opportunities: The expiration of patents and development of generic manufacturing channels could significantly alter the supply landscape, reducing costs and increasing accessibility.
FAQs
1. Who is the primary manufacturer of tecovirimat?
SIGA Technologies Inc. remains the sole approved and primary manufacturer of tecovirimat in the United States, with production supported through government contracts and licensed manufacturing partners.
2. Are there generic versions of tecovirimat available?
No, currently, no generic versions are approved. Future availability hinges on patent expiration, licensing agreements, and technology transfer initiatives.
3. What are the main challenges in sourcing tecovirimat globally?
Supply challenges include limited manufacturing capacity, regulatory delays in approvals, intellectual property restrictions, and logistical hurdles in distribution.
4. Can other countries manufacture tecovirimat?
Potentially, yes. Licensing agreements with foreign manufacturers could enable production outside the U.S., but such arrangements are currently limited and in developmental stages.
5. How does the supply of tecovirimat impact global preparedness for orthopoxvirus outbreaks?
Limited manufacturing capacity constrains rapid response and stockpiling efforts, underscoring the need for international collaboration, licensing, and capacity expansion to ensure readiness.
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