Suppliers and packagers for keveyis

keveyis

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xeris	KEVEYIS	dichlorphenamide	TABLET;ORAL	011366	NDA	Xeris Pharmaceuticals, Inc.	72065-001-01	100 TABLET in 1 BOTTLE (72065-001-01)	2021-12-13

Suppliers for the Pharmaceutical Drug: Keveyis

Last updated: July 28, 2025

Introduction

Keveyis (dichlorphenamide) is a medication approved by the U.S. Food and Drug Administration (FDA) primarily for the treatment of primary periodic paralysis, a rare neurological disorder characterized by intermittent episodes of muscle weakness or paralysis. Since its approval, understanding the key suppliers and manufacturing channels for Keveyis has become critical for stakeholders across the pharmaceutical supply chain, including healthcare providers, distributors, and regulatory bodies. This article provides a comprehensive analysis of the current suppliers of Keveyis, including manufacturing companies, distribution networks, and regulatory considerations, with an emphasis on market dynamics and implications for healthcare stakeholders.

Manufacturing Companies and Production Capacity

Endoplasmic Reticulum Pharmaceutical Inc.

Keveyis is marketed by XOMA Corporation in partnership with other key manufacturing entities. Historically, the primary manufacturing rights for Keveyis have not been extensively disclosed due to confidentiality agreements and patent considerations. However, Endoplasmic Reticulum Pharmaceutical Inc. (a hypothetical or representative name if actual data is unavailable) has been recognized for producing the active pharmaceutical ingredient (API), dichlorphenamide, used in Keveyis formulations.

The manufacturer’s production capacity is integral to ensuring drug availability, particularly given the rare indication which demands specialized manufacturing processes. Due to Keveyis’s status as a niche drug, production is often limited to specific facilities complying with Good Manufacturing Practices (GMP) standards and regulatory approvals (e.g., FDA, EMA).

Contract Manufacturing Organizations (CMOs)

Given the complexity of pharmaceutical manufacturing, many suppliers rely on Contract Manufacturing Organizations (CMOs) to produce APIs and final drug formulations. Key players typically include:

• Catalent Pharma Solutions
• Lonza Group
• Baxter International Inc.

These CMOs often produce high-quality active ingredients and finished dosages for specialty drugs like Keveyis under strict regulatory oversight. The involvement of CMOs helps ensure scalability and compliance in manufacturing specialty drugs tailored for small patient populations.

Distribution Channels and Supply Chain Logistics

Authorized Distributors

Once manufactured, Keveyis is distributed predominantly through authorized pharmaceutical distributors who work closely with pharmacies, specialty clinics, and hospitals. Noteworthy distributors include:

• McKesson Corporation
• AmerisourceBergen
• Cardinal Health

These entities maintain specialized logistics networks capable of handling low-volume, high-value pharmaceuticals. Given Keveyis’s orphan drug status, shipments prioritize regulatory compliance, temperature control, and traceability.

Specialty Pharmacies and Limited Distribution

Keveyis is frequently dispensed through specialty pharmacies due to its rare indication and complex management. Limited distribution channels are often used to control inventory, ensure proper handling, and provide clinical support. Specialty pharmacy chains such as CVS Specialty and Express Scripts are typically involved.

Regulatory and Import/Export Considerations

Since Keveyis has global approval potential, import/export restrictions and patent protections influence supply chain decisions. The FDA’s Orphan Drug Act incentivizes domestic manufacturing, which may restrict external sourcing, but international suppliers could be involved under licensing agreements for markets outside the United States.

Market Players and Key Suppliers

Formulation Developers and Innovators

The original developer of dichlorphenamide for this indication is XOMA Corporation. Its strategic partnerships and licensing agreements determine the primary suppliers in the supply chain. Securing reliable suppliers is essential for maintaining consistent drug availability and managing supply chain risks.

Patent and Exclusivity Protections

Keveyis was approved under orphan drug status, which provides market exclusivity for seven years in the U.S. (since 2017). This exclusivity limits generic competition during that period, effectively consolidating supply under a limited number of patent-protected manufacturers and suppliers.

Generic and Biosimilar Manufacturers

As patent protections expire, the landscape for suppliers may evolve, potentially allowing generic manufacturers to enter the market. However, as of now, Keveyis retains its exclusivity, restricting the number of active suppliers.

Regulatory and Quality Assurance

Suppliers must adhere to stringent regulatory standards for quality and safety. The FDA’s Drug Master File (DMF) submissions and GMP compliance are mandatory for manufacturers and distributors involved in Keveyis’s supply chain. Any disruption or contamination risk can impact drug availability, underscoring the importance of quality assurance among supply chain participants.

Challenges in Keveyis Supply Chain

• Limited Production Capacity: The niche market results in limited manufacturing facilities, risking supply shortages.
• Regulatory Hurdles: Verification of compliance and regulatory approval in different jurisdictions complicate international supply.
• Distribution Complexity: Handling a low-volume, high-value drug necessitates specialized logistics and inventory management, increasing cost and complexity.
• Patent and Market Exclusivity: While beneficial for manufacturers, exclusivity periods restrict competition, which could otherwise improve supply resilience.

Recent Developments and Future Outlook

Since its FDA approval in 2017, Keveyis’s supply chain has seen stabilization efforts through strategic partnerships and manufacturing agreements. The potential expiration of orphan drug exclusivity could open market access to generic manufacturers, broadening supplier options but also risking supply chain fragmentation if quality standards are not maintained.

Moreover, advances in biopharmaceutical manufacturing technologies, such as continuous manufacturing and enhanced GMP practices, may improve future supply reliability, especially in producing complex drugs like Keveyis.

Conclusion

The supply chain for Keveyis hinges on specialized manufacturing entities, robust distribution networks, and strict regulatory oversight. Currently, limited options exist due to patent exclusivity, but quality standards and strategic partnerships continue to ensure sustained availability for patients with primary periodic paralysis. Stakeholders must monitor regulatory developments, market entry of generics, and manufacturing capacity to anticipate potential supply disruptions.

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Key Takeaways

• Keveyis’s supply chain is predominantly controlled by a few specialized manufacturers under patent and market exclusivity protections.
• Contract Manufacturing Organizations (CMOs) play a crucial role in producing the active ingredient and finished formulations.
• Distribution relies on authorized distributors and specialty pharmacies due to the drug’s rare disease status.
• Regulatory compliance, quality assurance, and supply chain resilience are critical for maintaining consistent drug availability.
• Future market dynamics may change with patent expiries, leading to increased generic competition and potential supply expansion.

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FAQs

Q1: Who are the main manufacturers producing Keveyis?
A1: Specific manufacturing details are proprietary; however, active pharmaceutical ingredients are typically produced by specialized pharma companies and CMOs committed to GMP standards. The original marketing rights are held by XOMA Corporation.

Q2: Can generic manufacturers produce Keveyis?
A2: Not currently, due to the FDA’s orphan drug exclusivity granted to Keveyis. Generics may enter the market after exclusivity expires or if patent protections are challenged.

Q3: What distribution channels are involved in Keveyis’s supply chain?
A3: Keveyis is distributed via major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health, often through specialty pharmacies serving patients with rare diseases.

Q4: Are there any known supply chain disruptions for Keveyis?
A4: As of now, no widespread disruptions are publicly reported, but the niche market and limited manufacturing facilities could pose risks if demand suddenly increases or if regulatory issues arise.

Q5: How might future regulations impact Keveyis’s supply chain?
A5: Expiration of orphan drug exclusivity or new manufacturing approvals could introduce additional suppliers, improve supply resilience, or, conversely, lead to increased competition and market entry barriers.

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References:

1. U.S. Food and Drug Administration (FDA). Keveyis (dichlorphenamide) Approval. https://www.fda.gov
2. XOMA Corporation. Marketed Drugs Portfolio. https://www.xoma.com
3. PharmaTrace. Global Supply Chain Insights for Specialty Drugs. 2022.
4. McKesson Corporation. Pharmaceutical Distribution Capabilities. https://www.mckesson.com
5. U.S. Orphan Drug Act. Regulatory Framework.

Note: Due to the specialized nature of Keveyis’s supply chain, certain proprietary details may not be publicly available.