Suppliers and packagers for dilantin

dilantin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349	ANDA	Parke-Davis Div of Pfizer Inc	0071-0369-32	1000 CAPSULE in 1 BOTTLE (0071-0369-32)	1976-08-27
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349	ANDA	Parke-Davis Div of Pfizer Inc	0071-3740-66	100 CAPSULE in 1 BOTTLE (0071-3740-66)	1976-08-27
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349	ANDA	Viatris Specialty LLC	58151-110-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-01)	2024-12-06
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349	ANDA	Viatris Specialty LLC	58151-110-10	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-110-10)	2024-12-06
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349	ANDA	Viatris Specialty LLC	58151-110-88	100 BLISTER PACK in 1 CARTON (58151-110-88) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (58151-110-32)	2024-12-06

Suppliers for the Pharmaceutical Drug: DILANTIN

Last updated: August 11, 2025

Introduction

DILANTIN, the brand name for phenytoin sodium, is a widely prescribed antiepileptic medication primarily used for seizure control, including tonic-clonic seizures, partial seizures, and status epilepticus. Since its initial development in the late 1930s, DILANTIN has become a staple in epilepsy management worldwide, leading to an extensive global supply network. The robustness of its supply chain directly influences treatment continuity for millions of patients. Understanding its key suppliers, manufacturing landscape, and distribution channels offers valuable insights into market stability, risk factors, and opportunities for stakeholders.

Global Manufacturing Landscape

1. Original Manufacturer and Patent Status

DILANTIN was originally marketed by Pfizer (formerly Ciba-Geigy) after its synthesis by Friedrich Mast and his team in the late 1930s. Pfizer’s long-standing dominance in the market meant that the original formulations and patents controlled the supply chain for decades. However, with patent expirations and the subsequent rise in generic formulations, the landscape has diversified.

2. Generic Manufacturers

Following patent expiration in the late 20th century, multiple pharmaceutical companies began producing generic versions of phenytoin sodium. These generic manufacturers adhere to stringent regulatory standards such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (EP), ensuring bioequivalence and quality.

Leading global generic producers include:

• Alvogen: A prominent manufacturer with manufacturing facilities in the United States, Europe, and Asia, providing both oral suspensions and injectable formulations.
• Mylan (now part of Viatris): One of the largest generics producers globally, with a significant share in DILANTIN supply, especially oral tablets.
• Teva Pharmaceuticals: Known for its extensive generic portfolio, including phenytoin formulations supplied worldwide.
• Sandoz (Novartis): Offers high-quality generic phenytoin products, particularly in European markets.
• Hubei Yiman Pharmaceutical: A Chinese pharmaceutical company producing generic phenytoin for domestic and international markets.
• Accord Healthcare: Supplies both oral and injectable phenytoin, with facilities in India and Europe.

3. Biosimilar and Alternative Formulations

While traditional formulations dominate, biosimilar options and alternative delivery systems have begun emerging, though they are not yet mainstream for DILANTIN. These may influence future supply dynamics as patents for certain formulations expire or are challenged.

Supply Chain and Distribution Channels

1. Distributors and Wholesalers

Major pharmaceutical distributors, such as McKesson, Cardinal Health, and AmerisourceBergen, serve as intermediaries, ensuring wide distribution to hospitals, clinics, and pharmacies. These entities manage procurement from multiple manufacturers, balancing supply and demand fluctuations.

2. Regional and Local Suppliers

In many regions, especially emerging markets, local pharmaceutical companies produce or rebrand generic phenytoin, sometimes under different trade names. Their sourcing often relies on imported raw materials and finished products from larger manufacturers, emphasizing the importance of international trade agreements and import regulations.

3. Regulatory Oversight and Quality Assurance

Regulatory agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national bodies oversee manufacturing compliance, batch testing, and distribution to ensure consistent quality—critical given the narrow therapeutic index of phenytoin.

Major Suppliers by Geography

Region	Notable Suppliers	Market Share & Notes
United States	Pfizer, Mylan/Viatris, Teva, Alvogen	Dominated by both original and generic manufacturers; strict regulatory oversight ensures quality assurance.
Europe	Sandoz, Teva, Pfizer	Multiple licensed manufacturers and several active distribution channels; EU regulations promote high standards.
Asia-Pacific	Hubei Yiman, Sun Pharmaceutical, Cadila Healthcare	Growing production capacity, often serving both domestic and export markets; cost advantages promote extensive generics manufacturing.
Emerging Markets	Local manufacturers in India, China, Brazil	Often rely on imported raw materials; quality control varies but benefits from competitive pricing.

Market Dynamics and Risks

1. Patent Expiration & Generics Proliferation

Patent expirations in the late 20th and early 21st centuries have exponentially increased the number of suppliers, reducing costs and expanding access. However, this has also introduced variability in quality and supply consistency, prompting rigorous regulatory scrutiny.

2. Supply Chain Disruptions

Global events like the COVID-19 pandemic, geopolitical tensions, and raw material shortages have intermittently threatened DILANTIN supplies. Disruptions in key manufacturing regions, especially China and India, can have cascading effects on supply stability.

3. Regulatory and Quality Challenges

Ensuring high standards remains pivotal; substandard generic drugs can compromise patient safety. Regulatory agencies enforce stringent manufacturing practices, but deviations or non-compliance can result in recalls and supply interruptions.

Future Outlook

The gradual emergence of bioequivalent nearly identical formulations (biosimilars and specialized delivery methods) could alter the traditional supplier landscape. Additionally, with many patents expired, more companies may enter the market, increasing competition but also heightening the importance of supply chain resilience.

Manufacturers integrating advanced manufacturing technologies and quality control measures will likely lead the market. Governments and international agencies are also emphasizing strategic stockpiling and supply diversification to mitigate future shortages.

Conclusion

The supply of DILANTIN (phenytoin sodium) depends on a complex web of global manufacturers, distributors, and regulatory bodies. Leading generic producers like Mylan/Viatris, Teva, Sandoz, and Alvogen dominate the landscape, complemented by regional producers in Asia and emerging markets. While patent expirations have democratized supply, they also pose challenges related to quality assurance and supply stability. Stakeholders must monitor geopolitical, regulatory, and manufacturing trends to navigate risks effectively and ensure uninterrupted access to this critical anticonvulsant.

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Key Takeaways

• Diversified Supply Chain: DILANTIN's production involves multiple global generic manufacturers, primarily in North America, Europe, and Asia, ensuring broad accessibility but necessitating rigorous oversight.
• Major Suppliers: The leading suppliers include Mylan/Viatris, Teva, Pfizer, and Sandoz, with regional producers supplementing supply in emerging markets.
• Regulatory Impact: Stringent international standards safeguard quality, but supply disruptions remain a risk due to geopolitical and logistical factors.
• Market Dynamics: The expiration of patents has expanded manufacturing, increased competition, and reduced prices, enhancing global access but complicating supply stability.
• Future Trends: Emergence of biosimilars, advanced manufacturing, and strategic measures aim to bolster supply resilience amid evolving market conditions.

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FAQs

1. Who are the primary manufacturers of DILANTIN globally?
The leading global manufacturers include Pfizer (original patent holder), Mylan/Viatris, Teva Pharmaceuticals, Sandoz, and Alvogen, among others. These companies supply both branded and generic formulations across different regions.

2. How does patent expiration affect the supply of DILANTIN?
Patent expiration opened the market to numerous generic manufacturers, increasing supply and reducing costs. However, it also introduces variability in product quality and supply stability, emphasizing the need for strict regulatory compliance.

3. Are there regional differences in DILANTIN suppliers?
Yes. In North America and Europe, large multinational companies dominate, while in Asia and emerging markets, regional manufacturers like Hubei Yiman in China and Indian firms play significant roles, often relying on imported raw materials.

4. What risks threaten DILANTIN supply stability?
Risks include raw material shortages, manufacturing disruptions due to pandemics or geopolitical tensions, regulatory non-compliance, and supply chain interruptions in key production regions.

5. What is the outlook for DILANTIN suppliers?
Future supply stability depends on diversification, technological advancements, regulatory compliance, and strategic stockpiling. The potential introduction of biosimilars and alternative formulations could further influence supplier dynamics.

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Sources:
[1] U.S. Food and Drug Administration. "Abbreviated New Drug Application (ANDA) Filings."
[2] IQVIA. "Market Data Report on Antiepileptic Drugs."
[3] European Medicines Agency. "European Public Assessment Reports."
[4] Corporate websites of Pfizer, Mylan, Teva, Sandoz, and regional manufacturers.
[5] Industry analyses and peer-reviewed publications on pharmaceutical supply chains and generic drug manufacturing.