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. Seven 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:	88
Clinical Trials:	1
Patent Applications:	2,768
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
Parke Davis	CEREBYX	fosphenytoin sodium	INJECTABLE;INJECTION	020450-001	Aug 5, 1996

International Patents for CEREBYX

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

Country	Patent Number	Title	Estimated Expiration
Finland	101041
Spain	2086404
Canada	2067122
Israel	94504	Pharmaceutical composition of 3-(hydroxymethyl)-5,5-diphenylhydantoin disodium phosphate ester

Supplementary Protection Certificates for CEREBYX

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

CEREBYX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CEREBYX

Introduction

CEREBYX, known generically as fosphenytoin sodium, is a crucial medication in the management of seizures, particularly for conditions such as generalized tonic-clonic status epilepticus and during neurosurgery. This article delves into the market dynamics and financial trajectory of CEREBYX, highlighting its clinical significance, market competition, and financial performance.

Clinical Significance of CEREBYX

CEREBYX is indicated for the control of generalized tonic-clonic status epilepticus and the prevention and treatment of seizures during neurosurgery. It can also be used as a short-term substitute for oral phenytoin when oral administration is not possible[4].

Pharmacokinetics and Safety

CEREBYX offers several pharmacokinetic advantages over traditional phenytoin. It has better local tolerance, fewer infusion disruptions, and a shorter infusion period compared to phenytoin. This is critical in emergency settings where rapid and safe administration is essential[4].

Market Competition

The market for antiepileptic drugs is highly competitive, with several players offering generic and branded options. Mylan, for instance, launched a generic version of CEREBYX, which expanded the availability of fosphenytoin sodium and potentially impacted the market share of the branded product[1].

Financial Performance

The financial performance of CEREBYX is closely tied to its market demand and the overall financial health of its manufacturers and distributors.

Branded vs. Generic Market

The introduction of generic versions of CEREBYX can significantly impact the financial trajectory of the branded product. Generic versions, such as the one launched by Mylan, can capture a substantial portion of the market, reducing the revenue from the branded product. However, the generic market also expands the overall market size by making the drug more accessible and affordable[1].

Revenue Streams

For companies like Pfizer, which have partnerships related to the distribution and commercialization of similar antiepileptic drugs, the revenue streams can be substantial. For example, Pfizer's partnership with CStone Pharmaceuticals for the commercialization of sugemalimab in greater China involved significant upfront payments and milestone payments, although this is not directly related to CEREBYX, it illustrates the financial potential in the antiepileptic and neurology drug market[3].

Cost-Effectiveness

Pharmacoeconomic studies have shown that CEREBYX can be more cost-effective than phenytoin due to its lower frequency of adverse events and the resulting reduction in healthcare costs. A study comparing the costs of treating patients with fosphenytoin versus phenytoin found that the average cost to treat patients with fosphenytoin was lower, primarily due to the management of adverse events[2].

Market Size and Growth

The antiepileptic drug market is growing, driven by increasing prevalence of epilepsy and advancements in treatment options. While specific financial data for CEREBYX is not readily available, the overall market for antiepileptic drugs is expected to continue growing, influenced by factors such as new product launches, generic competition, and increasing healthcare spending.

Impact of Regulatory Approvals

Regulatory approvals and milestones can significantly impact the financial trajectory of drugs like CEREBYX. For instance, the approval of new formulations or the expansion of indications can increase market share and revenue. The recent interest in modified formulations, such as Captisol-enabled fosphenytoin sodium, indicates ongoing innovation in the field, which can influence market dynamics[5].

Financial Guidance and Projections

Companies involved in the production and distribution of CEREBYX or similar drugs often provide financial guidance that reflects market expectations. For example, Ligand Pharmaceuticals, which is involved in various life sciences technologies, reported significant revenue growth in 2020, partly due to increased sales of Captisol, a component used in some antiviral treatments. While this is not directly related to CEREBYX, it highlights the potential for strong financial performance in the broader pharmaceutical market[3].

Key Players and Partnerships

The financial trajectory of CEREBYX is also influenced by the strategies and partnerships of key players. Companies like Mylan, Pfizer, and Ligand Pharmaceuticals play significant roles in the market through their product portfolios, partnerships, and investments. These strategies can impact the market share, pricing, and overall financial performance of CEREBYX[1][3].

Conclusion

The market dynamics and financial trajectory of CEREBYX are influenced by several factors, including its clinical significance, market competition, cost-effectiveness, and regulatory approvals. Here are some key takeaways:

• Clinical Significance: CEREBYX is a critical medication for managing seizures, offering better pharmacokinetics and safety compared to traditional phenytoin.
• Market Competition: The introduction of generic versions can impact the market share of the branded product but also expands the overall market.
• Cost-Effectiveness: CEREBYX is more cost-effective due to lower adverse event frequencies and associated healthcare costs.
• Market Size and Growth: The antiepileptic drug market is growing, driven by increasing prevalence and advancements in treatment options.
• Regulatory Approvals: New formulations and expanded indications can increase market share and revenue.
• Financial Guidance: Companies involved in the production and distribution provide financial guidance reflecting market expectations.

FAQs

1. What is CEREBYX used for? CEREBYX is used for the control of generalized tonic-clonic status epilepticus and the prevention and treatment of seizures during neurosurgery. It can also be used as a short-term substitute for oral phenytoin when oral administration is not possible[4].

2. How does CEREBYX compare to phenytoin in terms of safety and pharmacokinetics? CEREBYX has better local tolerance, fewer infusion disruptions, and a shorter infusion period compared to phenytoin. It also offers more predictable pharmacokinetics, making it safer and more efficient in emergency settings[4].

3. What is the impact of generic versions on the market for CEREBYX? The introduction of generic versions can reduce the market share of the branded product but also expands the overall market by making the drug more accessible and affordable[1].

4. How does the cost-effectiveness of CEREBYX compare to phenytoin? CEREBYX is more cost-effective due to its lower frequency of adverse events and the resulting reduction in healthcare costs associated with managing these events[2].

5. What are the key factors influencing the financial trajectory of CEREBYX? Key factors include clinical significance, market competition, cost-effectiveness, regulatory approvals, and partnerships among key players in the pharmaceutical industry.

Sources

1. Mylan Launches Generic Cerebyx® Injection - Mylan Investor Relations
2. A pharmacoeconomic evaluation of intravenous fosphenytoin ... - PubMed
3. Ligand Reports Fourth Quarter and Full Year 2020 Financial Results - Ligand Investor Relations
4. CEREBYX® - accessdata.fda.gov - FDA
5. Comparison of pharmacokinetics and safety between CE ... - Frontiers in Pharmacology