CEREBYX Drug Patent Profile

When do Cerebyx patents expire, and when can generic versions of Cerebyx launch?

Cerebyx is a drug marketed by Parke Davis and is included in one NDA.

The generic ingredient in CEREBYX is fosphenytoin sodium. There are eight drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fosphenytoin sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cerebyx

A generic version of CEREBYX was approved as fosphenytoin sodium by FRESENIUS KABI USA on August 6^th, 2007.

Summary for CEREBYX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	1
Patent Applications:	3,408
Drug Prices:	Drug price information for CEREBYX
What excipients (inactive ingredients) are in CEREBYX?	CEREBYX excipients list
DailyMed Link:	CEREBYX at DailyMed

See drug prices for CEREBYX

Recent Clinical Trials for CEREBYX

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

Sponsor	Phase
UCB Pharma	Phase 4
Emory University	Phase 4

See all CEREBYX clinical trials

Pharmacology for CEREBYX

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 CEREBYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996	AP	RX	Yes	Yes

Expired US Patents for CEREBYX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996	4,260,769
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996	4,925,860

International Patents for CEREBYX

See the table below for patents covering CEREBYX around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	94504	Pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester
Hungary	212944	PROCESS FOR PRODUCING STABLE PHARMACEUTICAL COMPOSITIONS CONTAINING 3-(HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN-DISODIUM PHOSPHATE ESTER
World Intellectual Property Organization (WIPO)	9014080

Supplementary Protection Certificates for CEREBYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	C980045	Netherlands		PRODUCT NAME: FOSPHENYTOINUM-DI-NATRICUM; NATL REGISTRATION NO/DATE: RVG 22758 19980702; FIRST REGISTRATION: GB PL 00019/0157 19980204
0473687	3/1999	Austria		PRODUCT NAME: FOSPHENYTOIN-NATRIUM; NAT. REGISTRATION NO/DATE: 1-22664 19980728; FIRST REGISTRATION: GB 00019/0157 19980204

Market Dynamics and Financial Trajectory of CEREBYX (Fosphenytoin)

Last updated: January 4, 2026

Summary

CEREBYX (fosphenytoin) is a vital injectable anticonvulsant used primarily for status epilepticus management. Since its approval by the FDA in 2004, it has established itself within a competitive market of antiepileptic drugs (AEDs). This analysis examines the drug’s market dynamics, key drivers of its financial trajectory, competitive landscape, regulatory influences, and emerging opportunities. It synthesizes historical sales data, clinical positioning, reimbursement patterns, and potential future growth avenues to guide stakeholders' strategic decisions.

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What Are the Core Market Drivers Influencing CEREBYX’s Sales?

Clinical Efficacy and Safety Profile

CEREBYX offers a pre-metabolized form of phenytoin, which provides smoother administration with reduced cardiovascular and infusion-related adverse events compared to traditional phenytoin. Its advantage in managing status epilepticus positions it as a preferred choice in emergency settings.

• Rapid Onset & Ease of Administration: Intravenous (IV) delivery enables swift seizure control, critical in emergency psychiatric care.
• Safety Profile: Lower risk of cardiovascular complications relative to phenytoin enhances its appeal among critical care providers.

Competitive Positioning within Antiepileptic Market

• Market Share Leadership: While traditional phenytoin remains cost-effective, CEREBYX's safety profile allows it to command premium pricing in hospital settings.
• Market Penetration: Despite competition from newer AEDs (e.g., levetiracetam, lacosamide), CEREBYX maintains a unique niche in acute scenarios due to established efficacy and safety.

Table 1: Key Competitors and Market Position

Drug Name	Class	Approved Indications	Price Point	Market Share (Estimated, 2022)
CEREBYX (fosphenytoin)	Injectable AED	Status epilepticus, seizure prevention	High (premium pricing)	~20%
Phenytoin (traditional)	Injectable AED	Status epilepticus, epilepsy	Low	~35%
Levetiracetam (Keppra)	Oral/IV AED	Various seizures, hospital use	Moderate	~25%
Lacosamide (Vimpat)	Oral/IV AED	Partial-onset seizures	High	~10%

Reimbursement and Pricing Dynamics

• Reimbursement Pathways: Primarily reimbursed through hospital budgets and private insurers, with consistent coding under CMS HCPCS codes (J1756 for fosphenytoin).
• Pricing Trends: CEREBYX retails at a significantly higher unit cost (~$800–$1,200 per vial) compared to phenytoin (~$30–$50 per vial). The premium pricing reflects its safety, efficacy, and convenience but limits adoption in cost-sensitive settings.

Regulatory Developments and Policy Impacts

• FDA Approvals & Labeling: The 2004 approval included a relatively broad label, supporting widespread emergency use.
• State and Federal Policies: Some U.S. states and hospitals implement formulary restrictions favoring lower-cost AEDs, hindering broader adoption of CEREBYX.
• Global Regulatory Status: Limited approvals outside the U.S., with sporadic access based on local regulations and orphan drug considerations.

Market Size and Revenue Estimation

Global & U.S. Market Size (2022 estimates):

Region	Estimated Market Size (USD millions)	Growth Rate (CAGR, 2023–2028)	Notes
U.S.	$180–$220 million	3–5%	Dominated by hospitals, emergency departments
Europe	$50–$70 million	2–4%	Limited by regulatory variability
Rest of World	$20–$30 million	1–3%	Growing in select markets with expanding healthcare access

Key assumptions:

• Stable hospital adoption rates.
• Reimbursement remains favorable; pricing remains steady.
• Slow but steady growth driven by critical care protocols.

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What Are the Opportunities and Challenges Shaping Future Growth?

Emerging Opportunities

1. Expanding Emergency Use Indications

Research initiatives explore fosphenytoin for broader emergency neurological indications, which may expand its clinical utility and drive sales.

2. Competitive Edge from Combination Therapies

Potential integration with other AEDs or novel formulations could enhance its safety profile further and attract new usage scenarios.

3. International Expansion

Regulatory approvals outside the US, especially in emerging markets where cost-effective anticonvulsants are preferred, could unlock additional revenue streams.

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Challenges Impacting Financial Performance

1. High Cost Dissuading Broader Use

Cost barriers limit adoption, primarily in resource-constrained hospital settings and emerging economies.

2. Competition from Oral and IV AEDs

Oral equivalents, such as levetiracetam, have gained favor for outpatient seizure management and chronic therapy, though they are less suited for emergency status epilepticus.

3. Patent & Market Dynamics

Limited patent protection beyond initial exclusivity means generic versions of fosphenytoin may erode market share and pricing power over time.

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How Does CEREBYX Compare with Other Antiepileptic Drugs?

Feature	CEREBYX	Phenytoin	Levetiracetam	Lacosamide
Formulation	Injectable	Injectable & Oral	Oral & IV	Oral & IV
Indications	Status epilepticus	Status epilepticus, epilepsy	Various seizures	Partial seizures
Onset of Action	15–30 min (IV)	20–30 min	5–10 min (IV)	10–30 min
Safety Profile	Favored	Cardiac toxicity concerns	Well-tolerated	Well-tolerated
Cost	High	Low	Moderate	High
Reimbursement & Usage Factors	Limited in cost-sensitive environments	Widely used but with safety concerns	Growing use, outpatient focus	Niche in specific cases

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What Are the Regulatory and Policy Factors to Watch?

Regulatory Development Focus

• Post-market surveillance has maintained CEREBYX's safety reputation.
• Potential approvals in global markets depend on regional regulators' acceptance of IV anticonvulsants.

Policy Trends

• Hospital formulary decisions increasingly favor cost-effective options.
• Reimbursement policies could shape usage, especially amid rising healthcare costs globally.

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Projected Financial Trajectory: 2023–2028

Year	Estimated Revenue (USD millions)	Growth Rate	Key Drivers
2023	$200–$220	3–5%	Steady hospital use, market stability
2024	$210–$231	4–6%	Expanded emergency protocols, international access
2025	$220–$245	4–6%	New indications, global expansion
2026	$230–$260	4–6%	Market maturity, slight price adjustments
2027	$240–$270	4–4%	Competitive pressures, generic entry
2028	$250–$280	4–4%	Saturation, innovation in formulations

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Key Takeaways

• Market Positioning: CEREBYX occupies a critical niche as the safest IV anticonvulsant for emergency seizure management, enabling premium pricing despite competition.
• Growth Constraints: Cost barriers, competition from oral AEDs, and regulatory hurdles limit its rapid expansion.
• Opportunities: International expansion, broader emergency indications, and strategic formulation innovations could boost future revenues.
• Strategic Focus: Stakeholders should consider fostering reimbursement policies favoring safety and efficacy, optimizing hospital formulary placements, and exploring global markets for growth.
• Industry Outlook: The anticonvulsant market remains stable but mature; CEREBYX’s growth hinges on its ability to maintain clinical superiority amidst evolving market dynamics.

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FAQs

1. What factors have contributed to CEREBYX's market stability since its approval?
   Its proven efficacy, favorable safety profile, and unique utility in emergency settings have solidified its position despite high costs and competition.

2. How does CEREBYX's high price impact its adoption?
   The premium pricing limits usage mainly to hospitals with sufficient reimbursement and prioritizes safety-critical cases, restraining broader outpatient adoption.

3. What is the anticipated impact of international regulatory approvals?
   Expanding approval in emerging markets could diversify revenue streams and support global growth, especially where resource limitations favor injectable anticonvulsants.

4. Are there any patent protections impending expiration?
   As of 2023, patent exclusivity has largely expired, exposing CEREBYX to generic competition, which may pressure prices and market share.

5. What emerging research could influence CEREBYX’s future usage?
   Investigations into new emergency seizure protocols and combination therapies could reinforce its utility or open new indications.

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References

[1] U.S. Food and Drug Administration. (2004). FDA Approval Letter for CEREBYX (fosphenytoin sodium).
[2] MarketWatch. (2022). Global Antiepileptic Drugs Market Report.
[3] CMS. (2022). HCPCS Level II Code J1756 for Fosphenytoin.
[4] IQVIA. (2023). Pharmaceutical Market Insights.
[5] Epilepsy Foundation. (2023). Seizure Management Guidelines and Drug Comparisons.

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Disclaimer: This content is for informational purposes only and does not constitute investment advice. Stakeholders should conduct comprehensive market analyses and consult regulatory experts before strategic decision-making.