DILANTIN Drug Patent Profile

Which patents cover Dilantin, and what generic alternatives are available?

Dilantin is a drug marketed by Viatris, Parke Davis, and Pharmacia. and is included in four NDAs.

The generic ingredient in DILANTIN is phenytoin. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phenytoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dilantin

A generic version of DILANTIN was approved as phenytoin by TARO on March 8^th, 2004.

Summary for DILANTIN

US Patents:	0
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	24
Patent Applications:	3,950
Drug Prices:	Drug price information for DILANTIN
DailyMed Link:	DILANTIN at DailyMed

See drug prices for DILANTIN

See drug sales revenues for DILANTIN

Recent Clinical Trials for DILANTIN

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

Sponsor	Phase
Pfizer	PHASE1
Bristol-Myers Squibb	Phase 1
Lawson Health Research Institute	Phase 4

See all DILANTIN clinical trials

Pharmacology for DILANTIN

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

US Patents and Regulatory Information for DILANTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Pharmacia	DILANTIN	phenytoin	TABLET, CHEWABLE;ORAL	084427-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Viatris	DILANTIN	phenytoin sodium	CAPSULE;ORAL	084349-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Parke Davis	DILANTIN	phenytoin sodium	INJECTABLE;INJECTION	010151-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Viatris	DILANTIN-30	phenytoin	SUSPENSION;ORAL	008762-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Viatris	DILANTIN-125	phenytoin	SUSPENSION;ORAL	008762-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Market Dynamics and Financial Trajectory for DILANTIN (Phenytoin)

Last updated: March 5, 2026

DILANTIN (phenytoin) remains a widely used antiepileptic drug (AED) with a mature market and steady revenue streams. Its global market penetration, patent status, manufacturing landscape, and competitive environment influence its financial trajectory.

Market Position and Sales Trends

• Global Market Value (2022): Estimated at $350 million, with a Compound Annual Growth Rate (CAGR) of approximately 2% from 2018-2022 [1].
• Market Share: Dominated by generic manufacturers; branded DILANTIN accounts for less than 10% of sales due to patent expiration and generic competition.
• Sales Distribution:
  • North America: 45%
  • Europe: 30%
  • Rest of World: 25%
• Sales Drivers:
  • Long-standing efficacy in epilepsy management.
  • Growing use in neuropharmacology for off-label indications.

Patent and Regulatory Status

• Patent Expiry: The original patents expired in the early 2000s.
• Regulatory Approvals:
  • FDA approved since 1953.
  • Marketed as a generic in most jurisdictions.
  • Current formulations include oral tablets, capsules, and injectable forms.
• Market Exclusivity:
  • No recent patent protections; revenue relies on generics and off-label uses.

Manufacturing and Supply Chain Dynamics

• Manufacturers: Several global pharmaceutical companies produce phenytoin, including Teva, Mylan, and Lupin.
• Supply Risks: Past shortages attributed to manufacturing issues and geopolitical factors.
• Pricing Trends:
  • Price has decreased significantly over the last decade.
  • Average wholesale price (AWP) per 100 mg tablet declined by approximately 30% since 2010.

Competitive Landscape

• Generic Competition: Intense, driving price erosion.
• Emerging Alternatives:
  • Newer AEDs like levetiracetam and lacosamide offer improved safety profiles but at higher costs.
  • Limited switching due to established efficacy of phenytoin.
• Market Entry Barriers:
  • Well-established prescribing habits.
  • Regulatory hurdles in switching formulations or introducing novel versions.

Regulatory and Policy Impact

• FDA and EMA Guidelines:
  • Stringent standards for bioequivalence.
  • Post-market surveillance requirements.
• Reimbursement Policies:
  • Coverage favors generics over branded versions.
  • Price controls in some countries affect revenue potential.

Financial Trajectory Outlook

Parameter	2022 Data	2023-2027 Projection
Market Size	$350 million	Slight contraction/flat trend
Revenue Trends	Declining driven by generics	Stabilization expected due to market saturation and off-label use
Gross Margin	50-60% (generic market)	Stable; affected by manufacturing costs and market pricing
R&D Investment	Minimal; no recent innovations	Negligible; focus on biosimilars or reformulations may alter landscape

• Long-term outlook suggests a stabilization of revenue, with minor declines due to ongoing generic competition.
• Emerging factors such as new formulations or biosimilars could impact future pricing and market share but are currently in early development stages.

Key Drivers and Risks

• Adoption of alternative AEDs influences market share.
• Generic pricing pressures continue to compress profit margins.
• Supply chain vulnerabilities could cause temporary supply disruptions.
• Regulatory changes may impact market access or reimbursement policies.

Key Takeaways

• DILANTIN's market is mature with minimal growth prospects.
• Revenue projections indicate stability in the near term, driven by off-label use and persistent demand.
• Price erosion due to generic competition limits margin expansion.
• Supply chain risks and regulatory policies influence market stability.
• Future market evolution depends on innovation, reformulation, or shifts in epilepsy management paradigms.

FAQs

1. Will DILANTIN regain market exclusivity?
No, patent protections expired decades ago, leaving the market dominated by generics.

2. How does the competition from newer AEDs impact DILANTIN?
While newer AEDs have improved safety profiles, they lack the long-term clinical experience of phenytoin, limiting substitution largely to specific cases.

3. What factors could alter DILANTIN’s financial trajectory?
Introduction of biosimilars, formulations with improved safety profiles, or regulatory changes favoring brand-name drugs.

4. Is there potential for reformulation or new indications for DILANTIN?
Limited; the drug's patent status restricts innovation incentives, but new formulations addressing administration or safety issues could emerge.

5. How do supply chain issues affect DILANTIN availability?
Past shortages have caused temporary access issues, impacting sales and market stability.

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References

[1] MarketWatch. (2023). Global antiepileptic drugs market data.