PHENYTOIN - Generic Drug Details

What are the generic drug sources for phenytoin and what is the scope of patent protection?

Phenytoin is the generic ingredient in ten branded drugs marketed by Viatris, Actavis Mid Atlantic, Pai Holdings Pharm, Taro, Vistapharm Llc, Pharmacia, Epic Pharma Llc, Rising, Chartwell Molecular, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Lupin Ltd, Mankind Pharma, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Unichem, Wockhardt, Wockhardt Usa, Watson Labs, Pharmeral, Parke Davis, Acella, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Marsam Pharms Llc, Smith And Nephew, Solopak, and Warner Chilcott, and is included in forty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for phenytoin. Twelve suppliers are listed for this compound.

Summary for PHENYTOIN

US Patents:	0
Tradenames:	10
Applicants:	32
NDAs:	43
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	151
Patent Applications:	7,113
Drug Prices:	Drug price trends for PHENYTOIN
What excipients (inactive ingredients) are in PHENYTOIN?	PHENYTOIN excipients list
DailyMed Link:	PHENYTOIN at DailyMed

See drug prices for PHENYTOIN

See drug sales revenues for PHENYTOIN

Recent Clinical Trials for PHENYTOIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
First People's Hospital of Foshan	PHASE4
Meizhou People's Hospital	PHASE4
Shengjing Hospital	PHASE4

See all PHENYTOIN clinical trials

Pharmacology for PHENYTOIN

Drug Class	Anti-epileptic Agent
Mechanism of Action	Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inducers Cytochrome P450 3A Inducers
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Medical Subject Heading (MeSH) Categories for PHENYTOIN

Anticonvulsants

Cytochrome P-450 CYP1A2 Inducers

Voltage-Gated Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for PHENYTOIN

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for PHENYTOIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	PHENYTOIN	phenytoin	SUSPENSION;ORAL	040521-001	Mar 8, 2004	AB	RX	No	No
Fresenius Kabi Usa	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	089003-001	May 31, 1985		DISCN	No	No
Smith And Nephew	PHENYTOIN SODIUM	phenytoin sodium	INJECTABLE;INJECTION	088519-001	Dec 19, 1984		DISCN	No	No
Ani Pharms	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040435-001	Jun 20, 2003		DISCN	No	No
Chartwell Molecular	DIPHENYLAN SODIUM	phenytoin sodium	CAPSULE;ORAL	080857-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wockhardt Usa	EXTENDED PHENYTOIN SODIUM	phenytoin sodium	CAPSULE;ORAL	040732-001	Jan 30, 2008		DISCN	No	No

Market Dynamics and Financial Trajectory for Phenytoin

Last updated: February 19, 2026

What is the current market landscape for Phenytoin?

Phenytoin, an anticonvulsant primarily used to manage epilepsy, is a mature medication with a well-established market. It generates approximately $250-300 million annually worldwide. The drug’s global sales are concentrated in North America (around 50%), Europe (25%), and Asia Pacific (15%), with the remaining spread across other regions. The pharmaceutical market value for Phenytoin has seen slight declines over recent years, attributed to the availability of newer antiepileptic drugs with better safety profiles.

How do patent and regulatory statuses influence market dynamics?

Phenytoin's standard formulations, such as Dilantin, are off-patent, classified as generic drugs. This status limits profitability for branded manufacturers and fosters intense price competition. No recent patents are active as of 2023, resulting in a predominantly generics-driven market.

In the United States, the FDA approved generic versions in the early 2000s. In Europe, the European Medicines Agency (EMA) recognized the drug as generic, allowing multiple manufacturers. Pricing pressures from generics have reduced average unit costs by 40-60% over the past decade.

What are the key drivers of demand and supply?

Demand remains stable, driven by the drug's long-term use in epilepsy management, especially among patients resistant to newer medications. The prevalence of epilepsy is estimated at 50 million globally, with about 30% of cases requiring continuous anticonvulsant therapy.

Supply-side factors include manufacturing challenges and quality concerns. Several generic manufacturers experienced quality control issues in recent years, leading to market withdrawals or supply disruptions. This intermittency affects pricing and availability in certain regions.

How do competitive and technological shifts influence the market?

The advent of newer antiepilepsy drugs (e.g., levetiracetam, lamotrigine) has reduced Phenytoin's share in epilepsy treatment. These drugs offer fewer side effects and better pharmacokinetic profiles.

Biologics and personalized medicine are emerging trends, but their relevance to Phenytoin remains limited. The complexity of drug-resistant epilepsy cases continues to sustain Phenytoin demand among a niche patient base.

Developments in formulation technology, such as sustained-release preparations, have marginally extended Phenytoin’s commercial viability. However, no significant patent protections are available to extend exclusivity.

What are the future growth prospects?

The market is expected to decline modestly over the next five years. The global Epilepsy Market is projected to grow at approximately 4% CAGR, but Phenytoin's share is likely to shrink due to competition from newer therapies.

Emerging markets may sustain some demand due to lower-cost generics, especially in regions with limited access to newer drugs. Price sensitivity and regulatory pressures are expected to keep profit margins low for most manufacturers.

How do pricing trends shape financial trajectories?

Prices for generic Phenytoin have decreased by approximately 50% over the last decade. In the U.S., the average wholesale price per 100 mg dose has declined from about $0.30 to under $0.15. This trend strains profit margins for manufacturers, with margins currently estimated between 10-15%.

Pricing in developing countries remains significantly lower, often below $0.05 per dose, driven by local generic competitors. No major price increases are anticipated due to regulatory and reimbursement constraints.

What are the implications for investors and manufacturers?

Manufacturers face a declining revenue environment, with incremental innovations unlikely to generate substantial exclusivity gains. Investment focus may shift towards niche formulations, targeted delivery systems, or combination therapies.

For generic companies, consolidations and cost reductions will be critical to maintain profitability. For branded players, the challenge is limited, given the off-patent status, but opportunities may exist in niche formulations or regional markets.

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Key Takeaways

• Phenytoin’s market value stabilizes around $250-300 million annually, driven by existing demand and regional factors.
• The off-patent status curtails profit potential, with aggressive price competition dominating the market.
• Demand persists due to the drug’s role in resistant epilepsy cases, but newer therapies are replacing Phenytoin in many treatment protocols.
• Market prospects are declining, with an emphasis on cost reductions and niche applications.
• Supply disruptions and quality issues influence regional availability, affecting market stability.

FAQs

1. What factors threaten Phenytoin’s market stability?
Emergence of newer antiepileptic drugs with better safety profiles and ongoing price reductions threaten market stability.

2. Are there branded versions still protected by patents?
No, all major formulations are off-patent; only specialized or reformulated versions might retain some exclusivity.

3. How is the manufacturing landscape changing?
Manufacturers face quality control issues and supply disruptions, prompting market withdrawals and affecting availability.

4. Can emerging markets sustain growth for Phenytoin?
Yes, lower-cost generics in developing countries could sustain modest demand, but overall growth prospects are limited.

5. What innovations could extend Phenytoin’s commercial viability?
Formulation advancements, such as sustained-release forms, may generate niche markets, but lack of patent protection limits exclusivity.

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References:

[1] Epilepsy Foundation. (2022). Epilepsy facts.
[2] Evaluate Pharma. (2022). Global epilepsy market analysis.
[3] U.S. Food & Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations.
[4] European Medicines Agency. (2023). Marketing authorizations and approvals.
[5] IMS Health. (2022). Global prescription drug sales report.