Suppliers and packagers for generic pharmaceutical drug: RUFINAMIDE

RUFINAMIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eisai Inc	BANZEL	rufinamide	SUSPENSION;ORAL	201367	NDA	Eisai Inc.	62856-584-46	1 BOTTLE in 1 CARTON (62856-584-46) / 460 mL in 1 BOTTLE	2011-03-03
Alkem Labs Ltd	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	213410	ANDA	Ascend Laboratories, LLC	67877-673-62	1 BOTTLE in 1 CARTON (67877-673-62) / 460 mL in 1 BOTTLE	2021-02-24
Aurobindo Pharma	RUFINAMIDE	rufinamide	SUSPENSION;ORAL	216549	ANDA	Aurobindo Pharma Limited	59651-563-60	1 BOTTLE in 1 CARTON (59651-563-60) / 460 mL in 1 BOTTLE	2022-10-26

Suppliers for the Pharmaceutical Drug: RUFINAMIDE

Last updated: July 29, 2025

Introduction

Rufinamide is an anticonvulsant medication primarily prescribed for managing Lennox-Gastaut syndrome (LGS), a severe form of epilepsy. It functions by modulating sodium channels, thereby reducing seizure frequency. As a niche but vital drug within the anticonvulsant market, understanding the supply landscape for Rufinamide—comprising manufacturing companies, authorized distributors, and generic producers—is essential for stakeholders involved in procurement, healthcare delivery, and drug manufacturing. This article provides a comprehensive overview of current suppliers and the global supply chain dynamics for Rufinamide as of 2023.

Manufacturers of Rufinamide

The supply of Rufinamide is concentrated among a few key pharmaceutical companies that have obtained regulatory approval for manufacturing and marketing the drug. These include:

1. Eisai Co., Ltd.

Eisai, a Japanese multinational, holds the patent for Rufinamide and is the primary originator of the drug. It received approval from the U.S. Food and Drug Administration (FDA) in 2008 for Lennox-Gastaut syndrome treatment[^1^]. Eisai supplies Rufinamide primarily through its global distribution network, including North America, Europe, and certain Asian markets. Its manufacturing facilities are located in Japan, and it maintains strict quality control and supply chain standards aligning with international regulations.

2. Marketed Generics and Contract Manufacturers

Following patent expiration or licensing agreements, several generic manufacturers now produce Rufinamide, expanding availability in different regions.

• TEVA Pharmaceuticals: One of the leading generic drug manufacturers, TEVA obtained marketing authorization for Rufinamide in multiple markets, including the U.S. and European nations, under generic labels.^[2^]

• Mylan (now part of Viatris): Has developed generic formulations approved in various jurisdictions, contributing to increased supply diversity and reduced prices.^[3^]

• Sandoz (a Novartis division): Markets generic Rufinamide formulations in select regions, especially Europe and Asia.^[4^]

3. Contract Manufacturing Organizations (CMOs)

Some smaller or regional players serve as CMOs, manufacturing Rufinamide under license or for partnerships with brand owners, especially to meet localized demand. These include firms with expertise in complex small-molecule synthesis but often operate under confidentiality agreements.

Regional Supply Dynamics

North America

The primary supplier remains Eisai, with generics by TEVA and Mylan supplementing supply. The FDA-approved generics have increased availability, leading to competitive pricing and greater access for patients.

European Market

Eisai and Sandoz dominate the European supply chain. The regulatory landscape allows multiple generic manufacturers to market Rufinamide, fostering a robust supply network.

Asian Markets

Eisai continues to be a major supplier, supplemented by local generics manufacturers in India, China, and Southeast Asia, which produce Rufinamide under licensing agreements or through authorized generics, expanding regional access.

Emerging Markets

In Africa, Latin America, and parts of Asia, supply relies heavily on licensed generics produced in India and China. Local distributors distribute both brand-name and generic formulations, often contingent upon import regulations and local approvals.

Global Supply Chain and Challenges

Despite the presence of multiple suppliers, the supply of Rufinamide faces several challenges:

• Manufacturing Complexity: The synthesis of Rufinamide involves complex chemical processes, which limit the number of capable CMOs and manufacturers.

• Regulatory Barriers: Variations in regional approval processes, particularly in emerging markets, can delay or restrict supply.

• Patent and Licensing Constraints: Eisai's patent rights and licensing agreements can limit generic entry, although patent expirations have begun to open the market.

• Supply Chain Disruptions: As observed during the COVID-19 pandemic, disruptions in raw material availability, transportation, and production capacities impact drug availability.

Intellectual Property and Licensing

Eisai maintains patent protections in key markets, delaying generic entry. However, recent patent expirations or legal challenges have facilitated the entry of generics, notably in the U.S. post-patent expiry in 2014. Licensing arrangements with regional manufacturers enable authorized generics, which adhere to quality standards comparable to the original product.

Emerging Suppliers and Future Trends

The increasing demand for affordable epilepsy treatments has prompted the entry of regional generic players. Additionally, biosimilar and complex generic manufacturers are exploring advanced formulations and delivery mechanisms, potentially expanding Rufinamide's accessibility. Regulatory harmonization and broader licensing agreements are expected to further diversify the supply chain.

Conclusion

The supply landscape for Rufinamide is characterized by a combination of original patent holders, regional generic manufacturers, and CMOs, creating a diversified yet constrained supply chain. While Eisai remains the primary supplier globally, the expansion of generic manufacturing, especially in emerging markets, promises broader access at reduced costs. Stakeholders should monitor patent statuses, regulatory developments, and manufacturing capacities to optimize supply stability.

Key Takeaways

• Major Suppliers: Eisai Co., Ltd. dominates the initial and patent-protected market; generic manufacturers like TEVA, Mylan, and Sandoz significantly contribute post-patent expiry.
• Global Distribution: North America and Europe benefit from multiple approved generics, enhancing supply security and competitive pricing.
• Challenges: Complex manufacturing, patent protections, and regulatory barriers limit rapid market expansion and supply volume.
• Market Dynamics: Patent expirations and licensing agreements are pivotal for generic market growth, particularly in emerging economies.
• Future Outlook: Increased regional manufacturing, regulatory harmonization, and innovative formulations are poised to improve Rufinamide availability.

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FAQs

1. Who are the leading manufacturers of Rufinamide?
Eisai is the original patent holder and primary manufacturer. Several generic pharmaceutical companies, including TEVA, Mylan (Viatris), and Sandoz, manufacture authorized generics and biosimilars following patent expiration or licensing agreements.

2. How does patent protection affect the supply of Rufinamide?
Patent protections delay generic entry, maintaining higher prices and limiting supply expansion until patents expire or are challenged. Once patents expire, multiple generics can enter the market, increasing supply and reducing costs.

3. Are there regional differences in Rufinamide supply?
Yes. North America and Europe benefit from multiple generics and authorized manufacturers. In contrast, supply in emerging markets largely depends on regional generic producers, often licensed by original patent holders.

4. What are the main challenges in the manufacturing of Rufinamide?
Its complex synthesis minimizes the number of capable manufacturers and CMOs. Regulatory differences and legal patent protections further restrict market entry, impacting supply stability.

5. What is the outlook for Rufinamide supply in the coming years?
Expansion of generic manufacturing, patent expirations, and licensing are expected to improve global supply reliability. Regulatory harmonization and innovative formulations may further enhance accessibility.

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References

[1] FDA. Rufinamide (Intellectual Property and Approval Overview). 2008.

[2] TEVA Pharmaceuticals. Product labeling and approval information.

[3] Mylan/Viatris. Market authorization details for Rufinamide.

[4] Sandoz. European marketing authorization document.