ampyra: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250	NDA	Merz Pharmaceuticals, LLC	0259-5010-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0259-5010-60)	2010-03-01
Merz	AMPYRA	dalfampridine	TABLET, EXTENDED RELEASE;ORAL	022250	NDA	Merz Pharmaceuticals, LLC	10144-427-60	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10144-427-60)	2010-03-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

Ampyra (generic name: dalfampridine, also known as 4-aminopyridine) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for improving walking ability in patients with multiple sclerosis (MS). Its unique mechanism enhances nerve signal conduction by blocking voltage-gated potassium channels, thereby increasing walking speed and mobility for MS patients. As a specialized pharmaceutical, Ampyra’s supply chain involves multiple stakeholders, including the patent holder, manufacturing entities, and distribution channels. This analysis provides a comprehensive overview of suppliers involved in the production and distribution of Ampyra, emphasizing their roles, market influence, and implications for stakeholders.

Manufacturers and Patent Holders

Acorda Therapeutics, Inc. – The Original Innovator

Acorda Therapeutics, headquartered in Ardsley, New York, is the patent holder and primary manufacturer of Ampyra (dalfampridine extended-release tablets, 10 mg). Since receiving FDA approval in 2010, Acorda has maintained exclusive rights to produce and distribute Ampyra in the United States, positioning itself as the sole supplier within the domestic market. The company’s production facilities adhere to Good Manufacturing Practice (GMP) standards, ensuring quality and safety compliance.

In 2019, Acorda expanded its manufacturing capabilities through strategic collaborations and investments to meet increasing demand and maintain supply stability. Its manufacturing involves high-precision pharmaceutical synthesis, controlled-release formulation, and rigorous quality control protocols essential for maintaining drug efficacy.

Generic Manufacturers and Global Suppliers

Introduction of Generics Post-Patent Expiry

While Acorda initially held exclusivity, patent protections in the US for Ampyra expired in 2017, opening the market for generic producers. The availability of lower-cost generics enhances patient access but also diversifies the supplier landscape.

Key Generic Suppliers

Mylan (now part of Viatris):
Mylan received FDA approval for its generic version of dalfampridine extended-release tablets in 2018. As a global leader in generic pharmaceuticals, Viatris (post-merger with Mylan) operates manufacturing plants across the US, Europe, and Asia, producing high-quality generics that meet rigorous regulatory standards.
Teva Pharmaceuticals:
Teva has developed a generic dalfampridine product, leveraging its extensive manufacturing network spanning Israel, India, and Europe. Their focus on cost-effective production and global distribution channels makes Teva a prominent supplier in both U.S. and international markets.
Other Notable Generics Manufacturers:
Additional companies, such as Amneal Pharmaceuticals and Accord Healthcare, have received FDA approval for generic dalfampridine. These manufacturers primarily operate in the United States and Europe, contributing to the broader supply landscape.

International and Contract Manufacturers

Many pharmaceutical companies rely on Contract Manufacturing Organizations (CMOs) to produce active pharmaceutical ingredients (APIs) and finished formulations, especially for generic versions. This approach reduces costs, increases capacity, and mitigates supply risks.

API Suppliers:
The API (dalfampridine hydrochloride) is supplied by chemical producers in India, China, and Europe, such as Ruiyang Pharmaceutical Co., Ltd., and others compliant with international GMP standards.
Formulation and Packaging:
Final drug formulations are often produced at facilities certified by regulatory agencies such as the FDA and EMA, located across North America, Europe, and Asia. These facilities assemble, package, and distribute Ampyra or its generics globally.

Distribution and Supply Chain Dynamics

Once manufactured, Ampyra’s supply chain involves several layers:

Wholesalers and Distributors:
Major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen handle the logistics, warehousing, and delivery to pharmacies, hospitals, and clinics. Their extensive distribution networks ensure timely access to the medication.
Pharmacies and Healthcare Providers:
Retail and specialty pharmacies stock Ampyra, with distribution managed through pharmacy benefit managers (PBMs) and insurance plans to determine formulary placement.
International Exporters:
Generics produced outside the U.S. are exported through licensed channels, adhering to international regulations mandated by agencies such as the EMA (Europe) and PMDA (Japan).

Regulatory and Market Considerations

Patent Expiry and Market Entry:
The expiration of Acorda’s patent in 2017 significantly expanded the supplier pool, increasing competition and lowering prices.
Supply Chain Risks:
Dependence on international APIs and contract manufacturers exposes Ampyra’s supply chain to geopolitical, regulatory, and manufacturing risks. Supply disruptions in key countries like India and China could impact global availability.
Quality Assurance:
Regulatory bodies enforce stringent quality standards across all suppliers, with ongoing inspections and compliance checks necessary for maintaining GMP accreditation and continuous market authorization.

Implications for Stakeholders

Healthcare Providers and Payers:
Increased supplier options mean reduced costs and enhanced supply reliability, benefitting patient access.
Manufacturers:
Competition among generic producers incentivizes quality improvements and pricing strategies, but may pressure profit margins.
Patients:
The emergence of generics improves affordability and access, but supply security depends on stable manufacturing and distribution networks.

Conclusion

The supply landscape for Ampyra involves a complex interplay of patent-holders, generic manufacturers, contract suppliers, and distribution networks. Post-patent expiry, a proliferation of suppliers—namely Viatris (formerly Mylan), Teva, Amneal, and Accord Healthcare—has enhanced market competition and supply resilience. However, reliance on international APIs and contract manufacturing introduces vulnerabilities that stakeholders must monitor to ensure uninterrupted patient access.

Key Takeaways

Acorda Therapeutics remains the primary innovator but faces increased competition from multiple generic manufacturers post-patent expiry.
Generic suppliers such as Viatris, Teva, Amneal, and Accord Healthcare dominate the production of dalfampridine, expanding supply options and driving down costs.
Global API suppliers and CMOs play vital roles in ensuring manufacturing capacity and cost efficiency, albeit with supply chain risks linked to geopolitical and regulatory factors.
Strong regulatory oversight and quality assurance standards are central to supply chain integrity, affecting all suppliers and distributors.
Ongoing market dynamics, including patent cliffs and international trade policies, will shape the future landscape of Ampyra supply.

FAQs

1. Who are the main suppliers of Ampyra in the United States?
The primary suppliers include Acorda Therapeutics (patent holder) and several generic manufacturers such as Viatris (formerly Mylan), Teva Pharmaceuticals, Amneal Pharmaceuticals, and Accord Healthcare.

2. Has the patent expiration impacted the supply chain for Ampyra?
Yes. Patent expiration in 2017 introduced multiple generic manufacturers, increasing supply options, reducing costs, and improving market stability.

3. Where is the active pharmaceutical ingredient (API) for Dalfampridine sourced from?
APIs are primarily sourced from international suppliers in countries like India and China, with manufacturing facilities adhering to GMP standards.

4. Are there risks associated with Ampyra supply continuity?
Risks include dependency on international API suppliers, geopolitical issues, manufacturing disruptions, and regulatory compliance, which could impact global availability.

5. How do regulatory authorities influence Ampyra's supply chain?
Regulatory bodies such as the FDA and EMA enforce compliance standards, oversee manufacturing practices, and approve suppliers, ensuring safety and quality in the supply chain.

References

FDA. (2010). FDA approves Ampyra to improve walking in multiple sclerosis patients. [Link]
Acorda Therapeutics. (2022). Product Information: Ampyra (Dalfampridine Extended-Release Tablets).
FDA. (2018). FDA approves generic version of Ampyra (dalfampridine extended-release tablets).
Mylan-Viatris. (2021). Corporate overview and manufacturing capabilities.
Teva Pharmaceuticals. (2022). Product portfolio and manufacturing facilities.
European Medicines Agency (EMA). Guidelines on GMP.

Note: This article synthesizes publicly available information and industry insights up to the knowledge cutoff in 2023.

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