FOSPHENYTOIN SODIUM Drug Patent Profile

Which patents cover Fosphenytoin Sodium, and when can generic versions of Fosphenytoin Sodium launch?

Fosphenytoin Sodium is a drug marketed by Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Hikma Farmaceutica, Hospira, Pharmobedient, Sun Pharm, and Wockhardt Bio Ag. and is included in fourteen NDAs.

The generic ingredient in FOSPHENYTOIN SODIUM 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 Fosphenytoin Sodium

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

Summary for FOSPHENYTOIN SODIUM

US Patents:	0
Applicants:	12
NDAs:	14
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	1,121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSPHENYTOIN SODIUM
DailyMed Link:	FOSPHENYTOIN SODIUM at DailyMed

Recent Clinical Trials for FOSPHENYTOIN SODIUM

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

Sponsor	Phase
Nobelpharma	Phase 3
Shaheed Zulfiqar Ali Bhutto Medical University	N/A
Banaras Hindu University	Phase 2

See all FOSPHENYTOIN SODIUM clinical trials

Pharmacology for FOSPHENYTOIN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for FOSPHENYTOIN SODIUM

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

N03AB	Hydantoin derivatives
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for FOSPHENYTOIN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078277-001	Aug 6, 2007		DISCN	No	No
Gland	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	214926-001	Oct 13, 2023	AP	RX	No	No
Apotex Inc	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078126-001	Aug 6, 2007		DISCN	No	No
Pharmobedient	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078736-001	Jun 8, 2010		DISCN	No	No

Market Dynamics and Financial Trajectory for Fosphenytoin Sodium

Last updated: February 19, 2026

Fosphenytoin sodium is a prodrug of phenytoin, approved mainly for preventing and controlling seizures, including status epilepticus. Its market landscape is influenced by regulatory status, competitive alternatives, and prescribing trends.

Regulatory and Approval Status

Fosphenytoin received FDA approval in 1996 for intravenous and intramuscular administration for seizure management. It holds approval in several other countries with comparable indications. It is marketed under the brand name Cerebyx.

Market Size and Growth Drivers

The global market for anticonvulsants, including fosphenytoin, is valued at approximately USD 4.7 billion in 2022. The compound's share is driven by its safer profile compared to phenytoin, featuring reduced risk of cardiovascular and dermatologic adverse effects.

Market Segments and Key Players

Segment	Share (%)	Key Companies
Hospital-based intravenous treatment	60	Pfizer (Cerebyx), Teva
Oral adoption for seizure control	25	Less common
Emergency seizure management	15	Pfizer, Other generics

Pfizer remains the dominant manufacturer, with generic companies increasingly capturing market share due to price competition.

Trends Affecting Market Growth

• Expansion of intravenous seizure management protocols.
• Growing adoption in acute therapy settings.
• Shift toward drugs with fewer infusion-related adverse effects.

Competitive Landscape

The primary competitor remains phenytoin, which costs approximately 20% less. Levetiracetam shows some substitution potential, especially for outpatient settings, but lacks intravenous form's rapid action.

Pricing Dynamics

• Fosphenytoin: USD 70 – USD 120 per vial (USD 350 – USD 600 per course).
• Phenytoin: USD 20 – USD 50 per vial.
• Levetiracetam: USD 150 per dose.

Pricing pressures from generics are expected to limit revenue growth.

Revenue and Market Penetration Forecast

Analysts project a compound annual growth rate (CAGR) of approximately 2% for fosphenytoin from 2023 to 2028. The modest growth rate reflects market saturation, replacement by newer agents, and pricing constraints.

Revenue Breakdown (2023–2028)

Year	Estimated Revenue (USD billion)	Growth Rate (%)
2023	0.55	—
2024	0.56	1.8
2025	0.58	3.6
2026	0.60	3.4
2027	0.62	3.2
2028	0.64	3.2

Financial Opportunities and Risks

Opportunities

• Expansion into emerging markets with developing healthcare systems.
• New formulations or delivery mechanisms might increase compliance.
• Strategic partnerships with generic manufacturers could stabilize revenue.

Risks

• Regulatory restrictions due to safety concerns.
• Competition from newer seizure drugs with better safety profiles.
• Budget constraints in healthcare systems reducing intravenous drug utilization.

Market Entry and Investment Considerations

Investors considering fosphenytoin should note the slow growth trajectory, constrained by market saturation and price competition. Companies aiming to expand should innovate delivery systems or target unaddressed regional markets.

Key Takeaways

• Fosphenytoin's market remains stable but slow-growing, primarily driven by hospital-based intravenous applications.
• Pfizer maintains dominant market share; generics are eroding revenue.
• Competition from newer anticonvulsants and safety concerns could limit future growth.
• Price sensitivity remains high, emphasizing cost-focused market strategies.
• Expansion opportunities exist in emerging regions and through formulation improvements.

FAQs

1. What are the main clinical advantages of fosphenytoin over phenytoin?
Fosphenytoin has fewer cardiovascular and dermatological adverse effects and can be administered more rapidly intravenously.

2. How does the market share of fosphenytoin compare with newer seizure medications?
Fosphenytoin’s share is diminishing relative to drugs such as levetiracetam, which are preferred for chronic outpatient management.

3. What regulatory challenges does fosphenytoin face?
Concerns over adverse effects may lead to restrictions or requirements for additional safety data in certain jurisdictions.

4. Are there any upcoming formulations or patents that could impact the market?
Currently, no major patent expirations or new formulations are anticipated that could significantly alter market dynamics.

5. How significant is the emerging markets segment for fosphenytoin?
While currently small, it offers growth potential due to expanding healthcare infrastructure, subject to regulatory approval and cost considerations.

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References

1. MarketsandMarkets. (2022). Anticonvulsants Market. https://www.marketsandmarkets.com
2. FDA. (1996). FDA approval documents for Cerebyx. https://www.fda.gov
3. IQVIA. (2022). Global Pharmaceutical Market Data. https://www.iqvia.com