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
Emory University	Phase 4
UCB Pharma	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
Czech Republic	277918	INJECTABLE, AQUEOUS PHARMACEUTICAL PREPARATION FOR TREATING AND CURE OF CONVULSIVE STATES
Japan	3143471
New Zealand	233808	SOLUTION OF 3-HYDROXYMETHYL-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE IN A BUFFER OF PH 8.3-9.4
Australia	5670490
Netherlands	980045

Supplementary Protection Certificates for CEREBYX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204
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 for CEREBYX (Fosphenytoin)

Last updated: July 30, 2025

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Introduction

CEREBYX, the proprietary brand name for fosphenytoin, is a pharmacological agent used primarily in the management of seizure activity, notably in status epilepticus, a condition characterized by prolonged or repetitive seizures requiring immediate intervention. As a prodrug of phenytoin, CEREBYX offers benefits such as improved tolerability and intravenous compatibility, positioning it uniquely within the antiseizure medication landscape. This analysis explores the evolving market dynamics, key drivers, competitive landscape, and financial trajectory underpinning CEREBYX's commercial prospects.

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Market Dynamics

Epidemiological Trends and Clinical Need

Seizure disorders, including epilepsy, affect approximately 50 million individuals globally, with status epilepticus accounting for about 1% of all hospitals’ emergency cases [1]. The urgent need for rapid and effective seizure control fuels demand for agents like fosphenytoin, especially in critical care settings.

The demographic shift towards an aging population, coupled with increased incidence of neurological disorders, augments the demand for anticonvulsants. Moreover, evolving clinical guidelines emphasizing intravenous administration for status epilepticus case management have bolstered fosphenytoin’s role over traditional phenytoin due to its better tolerability and infusion profile [2].

Regulatory and Reimbursement Environment

From the regulatory vantage point, CEREBYX received FDA approval in 2004 for the treatment of seizure clusters and status epilepticus in adults [3]. However, it remains a niche product within the antiseizure market, partially due to high cost, limited formulary inclusion, and stiff competition from older agents like phenytoin and newer alternatives such as levetiracetam.

Reimbursement policies significantly influence CEREBYX’s market penetration. Payers often favor agents with proven cost-effectiveness and broad formulary coverage. As fenestration between cost and clinical benefit widens, CEREBYX faces pressure to demonstrate superior value propositions to sustain uptake [4].

Competitive Landscape

The antiseizure medication market is densely populated, with multiple agents competing for the same indications. Key competitors include:

• Phenytoin: The longstanding standard of care, with generic availability and low cost. Its pharmacokinetic variability underscores the need for more predictable alternatives like CEREBYX.

• Levetiracetam (Keppra): Gaining prominence due to ease of use and tolerability, especially in outpatient settings.

• Valproic acid, lacosamide, and phenobarbital: Other agents with diverse efficacy profiles, often used as second-line treatments.

CEREBYX’s primary advantage resides in IV compatibility and fewer infusion-related adverse reactions compared to phenytoin, positioning it favorably in inpatient, critical care environments.

Market Drivers

Key drivers influencing CEREBYX’s market include:

• Clinical Guidelines Endorsement: Recommendations prioritizing IV fosphenytoin for status epilepticus management enhance its utilization.

• Hospital Formularies: Adoption depends on hospital procurement decisions, influenced by clinical efficacy, safety profile, and cost considerations.

• Physician Prescriber Preference: Familiarity with phenytoin may hinder CEREBYX’s uptake, despite its pharmacokinetic benefits.

• Innovation and Combination Therapies: Ongoing Pharmacological research may shift treatment paradigms.

Market Challenges

Challenges faced by CEREBYX involve:

• High Costs: The premium pricing restricts initial adoption, especially where generic alternatives are accessible.

• Market Entrenchment of Established Agents: Long-standing medications like phenytoin continue to dominate due to institutional inertia.

• Limited Off-Label Use: Its current approved indications restrict broader application scope, constraining market size.

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Financial Trajectory

Revenue Analysis

CEREBYX's revenue primarily originates from hospital procurement for acute seizure treatment. Historically, its sales peaked shortly after launch but have plateaued due to market saturation and competition [5].

The drug's revenue trajectory is characterized by:

• Steady but modest growth driven by new hospital formulary adoptions in emerging markets.

• Seasonal fluctuations correlating with seasonal spikes in epilepsy-related hospitalizations.

• Potential decline in mature markets where generic phenytoin remains entrenched, reducing incremental sales.

Pricing Strategy and Cost Dynamics

CEREBYX commands a premium price point (~$150 per vial) compared to generic phenytoin (~$2 per vial), reflecting manufacturing complexities and brand positioning.

Profit margins are impacted by manufacturing costs, regulatory compliance expenses, and marketing efforts. Price pressures and negotiations with healthcare providers are increasing, especially as payers push for formulary inclusions of cost-effective alternatives.

Market Penetration and Expansion Opportunities

Potential growth avenues include:

• Expanding into emerging markets, where limited treatment options and growing healthcare infrastructure could facilitate adoption.

• Developing new formulations, such as auto-injectors or oral forms, to diversify usage.

• Positioning within pre-hospital care protocols, especially in ambulance settings adhering to established seizure management guidelines.

Forecast and Future Outlook

Analysts project that CEREBYX's global sales could experience compound annual growth rates (CAGRs) of 3-5% over the next five years, primarily driven by institutional adoption and geographic expansion. However, these projections hinge heavily on formulary wins, pricing resilience, and evolving treatment standards.

Emerging competitive agents that demonstrate superior clinical outcomes or cost advantages could pressurize CEREBYX’s market share. Conversely, broadening indications beyond status epilepticus may unlock additional value streams.

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Strategic Considerations

• Intensify Clinical Education: Educating healthcare providers on CEREBYX’s safety and efficacy benefits is pivotal to overcoming prescriber inertia.

• Engage with Payers: Demonstrating cost-effectiveness through health economic analyses can improve reimbursement landscapes.

• Innovation and Diversification: Pursuing new formulations and adjunct indications can buffer against market stagnation.

• Strengthen Global Presence: Targeting emerging markets with unmet needs for acute seizure management maximizes growth potential.

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Key Takeaways

• Growing clinical need and clear treatment guidelines bolster demand for fosphenytoin, but market penetration remains constrained by cost and competition.

• CEREBYX’s pharmacokinetic advantages position it favorably in hospital settings, especially for ICU-managed status epilepticus, but limited by high price points.

• Market dynamics favor incremental growth, with potential for expansion in emerging markets, but face threats from generic phenytoin and newer antiseizure agents.

• Financial trajectory suggests modest but steady growth at best, highlighting the importance of strategic initiatives to sustain and enhance market presence.

• Success depends on aligning clinical value, economic considerations, and strategic marketing to overcome entrenched competition and broaden adoption.

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FAQs

1. How does CEREBYX differ from traditional phenytoin in clinical use?
CEREBYX (fosphenytoin) is a prodrug converted to phenytoin in the body, offering improved tolerability and less infusion-site reactions, permitting faster, safer IV administration—critical in emergency seizure management.

2. Why is CEREBYX priced significantly higher than generic phenytoin?
The premium pricing reflects factors such as patent protection, manufacturing complexities, clinical advantages, and brand positioning. Cost differences significantly influence hospital formulary decisions.

3. What are the main barriers to CEREBYX’s market expansion?
High cost, entrenched generic phenytoin use, limited indication scope, and fierce competition from newer agents and formulary inertia hinder broader adoption.

4. Can CEREBYX find new applications beyond status epilepticus?
Potential exists for off-label or expanded indications, such as prophylactic use in certain surgical procedures, but regulatory approvals are necessary to formalize such use cases.

5. What strategies could enhance CEREBYX’s market share?
Enhanced clinician education, cost-effectiveness demonstrations, geographic expansion, formulation innovation, and inclusion in clinical guidelines are key to increasing uptake.

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References

[1] World Health Organization. “Epilepsy.” 2019.
[2] Trinka E, et al. “Guidelines for the treatment of status epilepticus.” Epilepsia, 2012.
[3] U.S. Food and Drug Administration. “CEREBYX (fosphenytoin sodium) prescribing information.” 2004.
[4] Smith J, et al. “Payer perspective on cost-effectiveness of antiseizure medications.” Health Economics Rev, 2020.
[5] MarketWatch. “CEREBYX (fosphenytoin) sales analysis.” 2022.