FOSPHENYTOIN SODIUM - Generic Drug Details

What are the generic sources for fosphenytoin sodium and what is the scope of patent protection?

Fosphenytoin sodium is the generic ingredient in three branded drugs marketed by Parke Davis, Am Regent, Amneal, Apotex Inc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hikma Farmaceutica, Hospira, Norvium Bioscience, Sun Pharm, Wockhardt, and Lupin, and is included in sixteen NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fosphenytoin sodium has fifty-one patent family members in fourteen countries.

There are eight drug master file entries for fosphenytoin sodium. Seven suppliers are listed for this compound.

Summary for FOSPHENYTOIN SODIUM

International Patents:	51
US Patents:	5
Tradenames:	3
Applicants:	14
NDAs:	16
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	3
Patent Applications:	1,369
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FOSPHENYTOIN SODIUM
What excipients (inactive ingredients) are in FOSPHENYTOIN SODIUM?	FOSPHENYTOIN SODIUM excipients list
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
Wockhardt	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078137-001	Aug 6, 2007	AP	RX	No	No
Sun Pharm	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078417-001	Mar 18, 2008	AP	RX	No	No
Amneal	FOSPHENYTOIN SODIUM	fosphenytoin sodium	INJECTABLE;INJECTION	078476-001	Mar 18, 2008		DISCN	No	No
Lupin	SESQUIENT	fosphenytoin sodium	SOLUTION;INTRAVENOUS	210864-002	Nov 5, 2020		DISCN	Yes	No	9,200,088		Y

Expired US Patents for FOSPHENYTOIN SODIUM

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 FOSPHENYTOIN SODIUM

Country	Patent Number	Title	Estimated Expiration
South Korea	20200106100	알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same)
Mexico	2014010323	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.)
European Patent Office	2268269	COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Russian Federation	2747757	КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION)

Supplementary Protection Certificates for FOSPHENYTOIN SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	99C0008	Belgium		PRODUCT NAME: FOSPHENYTOINUM DINATRICUM; REGISTRATION NO/DATE: 19 IS 102 F12 19980901; FIRST REGISTRATION: GB PL00019/1057 19980204

FOSPHENYTOIN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fosphenytoin Sodium

Introduction

Fosphenytoin sodium is a prodrug that is converted to phenytoin, a well-established anticonvulsant, upon administration. This drug is crucial in the management of seizures and status epilepticus. Here, we will delve into the market dynamics and financial trajectory of fosphenytoin sodium.

Market Overview

The global market for fosphenytoin sodium injection has been steadily growing, driven by the increasing demand for effective antiepileptic drugs.

Global Market Size and Growth

The global fosphenytoin sodium injection market was valued at a significant amount in 2021 and is projected to grow at a compound annual growth rate (CAGR) over the next decade. This growth is attributed to the rising incidence of epilepsy, advancements in healthcare infrastructure, and the need for more efficient and safer anticonvulsant treatments[5].

Demand Drivers

Several factors are driving the demand for fosphenytoin sodium:

Increasing Prevalence of Epilepsy

The global prevalence of epilepsy is on the rise, which directly increases the demand for antiepileptic drugs like fosphenytoin sodium. This trend is expected to continue, contributing to the market's growth.

Advantages Over Traditional Phenytoin

Fosphenytoin sodium offers several advantages over traditional phenytoin, including a lower risk of severe cardiovascular reactions and the ability to be administered at a faster rate without the need for dilution. These benefits make it a preferred choice in clinical settings, boosting its market demand[2].

Clinical Efficacy and Safety

Studies have shown that fosphenytoin sodium can deliver free phenytoin to the same rate and extent as traditional phenytoin under specific conditions of dose and rate of administration. This equivalence in efficacy, combined with its safety profile, enhances its market appeal[3].

Financial Trajectory

Revenue Projections

The revenue generated by the fosphenytoin sodium injection market is expected to increase significantly by 2030. This growth is driven by increasing adoption in hospitals and clinics, as well as expanding market penetration in developing regions[5].

Cost and Pricing Dynamics

The cost of fosphenytoin sodium can vary based on the region, healthcare system, and availability of generic versions. However, the overall trend suggests that while the cost per unit may remain relatively stable, the total market revenue will increase due to higher volumes and broader usage.

Impact of Regulatory Changes

Regulatory changes, such as those introduced by the Inflation Reduction Act, can influence the financial trajectory of prescription drugs. While these changes primarily affect out-of-pocket spending and aggregate drug costs, they can also impact the pricing and reimbursement landscape for fosphenytoin sodium. For instance, provisions aimed at reducing drug costs could lead to more affordable access to this medication, potentially increasing its adoption and market size[4].

Market Segmentation

By Region

The market for fosphenytoin sodium is segmented by region, with North America and Europe being significant contributors due to their well-established healthcare systems and high demand for antiepileptic drugs. However, emerging markets in Asia-Pacific and Latin America are also expected to grow rapidly due to improving healthcare infrastructure and increasing awareness of epilepsy treatment options[5].

By Distribution Channel

The distribution channels for fosphenytoin sodium include hospitals, clinics, and retail pharmacies. Hospitals and clinics are the primary consumers, given the drug's use in acute care settings such as status epilepticus.

Competitive Landscape

Key Players

The market for fosphenytoin sodium is dominated by a few key players, including Parke-Davis (now part of Pfizer), which markets the drug under the brand name Cerebyx. Other generic manufacturers also play a significant role, offering competitive pricing and contributing to the market's growth[3].

Generic Competition

The presence of generic versions of fosphenytoin sodium has increased competition in the market, driving prices down and making the drug more accessible to a broader patient population. This competition is expected to continue, influencing the market dynamics and financial trajectory of the drug.

Special Populations and Market Impact

Patients with Renal or Hepatic Disease

Patients with renal or hepatic disease, or those with hypoalbuminemia, require careful monitoring when administered fosphenytoin sodium due to changes in phenytoin binding and clearance. This segment of the market may require tailored dosing strategies, which can impact the overall market dynamics and financial performance of the drug[2].

Future Outlook

Technological Advancements

Advancements in drug delivery systems and pharmacokinetics could further enhance the market for fosphenytoin sodium. Improvements in formulation and administration methods could make the drug more convenient and safer to use, potentially increasing its adoption.

Market Expansion

The market for fosphenytoin sodium is expected to expand into new regions and patient populations. Increasing awareness of epilepsy and the availability of effective treatments will drive this expansion, contributing to the drug's financial growth.

Key Takeaways

• The global fosphenytoin sodium injection market is growing due to increasing demand for antiepileptic drugs.
• Fosphenytoin sodium offers several advantages over traditional phenytoin, including a safer administration profile.
• Regulatory changes and generic competition are key factors influencing the market dynamics and financial trajectory.
• The market is expected to expand into new regions and patient populations, driven by technological advancements and increasing awareness of epilepsy treatment.

FAQs

Q: What is fosphenytoin sodium, and how does it work? A: Fosphenytoin sodium is a prodrug that is converted to phenytoin, an anticonvulsant, upon administration. It works by modulating voltage-dependent sodium channels and inhibiting calcium flux across neuronal membranes[1].

Q: What are the advantages of fosphenytoin sodium over traditional phenytoin? A: Fosphenytoin sodium can be administered at a faster rate without dilution and has a lower risk of severe cardiovascular reactions compared to traditional phenytoin[2].

Q: How is the global market for fosphenytoin sodium expected to grow? A: The global market for fosphenytoin sodium is expected to grow at a significant CAGR over the next decade, driven by increasing demand and expanding market penetration[5].

Q: What impact do regulatory changes have on the market for fosphenytoin sodium? A: Regulatory changes can influence pricing, reimbursement, and overall market dynamics. For example, provisions aimed at reducing drug costs can make fosphenytoin sodium more affordable and increase its adoption[4].

Q: Who are the key players in the fosphenytoin sodium market? A: The market is dominated by key players such as Parke-Davis (now part of Pfizer), which markets the drug under the brand name Cerebyx, along with other generic manufacturers[3].

Sources

1. FOSPHENYTOIN SODIUM INJECTION, USP 100 mg PE/2 mL - FDA Label[1]
2. Fosphenytoin Sodium Injection, USP - FDA Label[2]
3. Cerebyx (Fosphenytoin Sodium) Inj 750MG/ML - FDA NDA[3]
4. Recent and Forecasted Trends in Prescription Drug Spending - Health System Tracker[4]
5. Global Fosphenytoin Sodium Injection Market 2024-2030 - Mobility Foresights[5]