Felbamate - Generic Drug Details

What are the generic drug sources for felbamate and what is the scope of freedom to operate?

Felbamate is the generic ingredient in two branded drugs marketed by Amneal Pharms, Novitium Pharma, Taro, Mylan Speciality Lp, Alvogen, Ani Pharms, and Zydus Lifesciences, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for felbamate. Eleven suppliers are listed for this compound.

Summary for felbamate

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	9
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	115
Clinical Trials:	6
Patent Applications:	6,293
Drug Prices:	Drug price trends for felbamate
What excipients (inactive ingredients) are in felbamate?	felbamate excipients list
DailyMed Link:	felbamate at DailyMed

See drug prices for felbamate

Recent Clinical Trials for felbamate

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

Sponsor	Phase
Laboratorios Grossman, S.A.	Phase 3
Instituto Nacional de Salud Publica, Mexico	Phase 3
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all felbamate clinical trials

Pharmacology for felbamate

Drug Class	Anti-epileptic Agent
Physiological Effect	Decreased Central Nervous System Disorganized Electrical Activity

Anatomical Therapeutic Chemical (ATC) Classes for felbamate

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

US Patents and Regulatory Information for felbamate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alvogen	FELBAMATE	felbamate	TABLET;ORAL	204595-002	Jan 11, 2016	AB	RX	No	No
Zydus Lifesciences	FELBAMATE	felbamate	TABLET;ORAL	208970-001	May 30, 2017	AB	RX	No	No
Zydus Lifesciences	FELBAMATE	felbamate	TABLET;ORAL	208970-002	May 30, 2017	AB	RX	No	No
Novitium Pharma	FELBAMATE	felbamate	SUSPENSION;ORAL	211333-001	May 31, 2019	AB	RX	No	No
Taro	FELBAMATE	felbamate	SUSPENSION;ORAL	206314-001	Jun 16, 2017	AB	RX	No	No
Taro	FELBAMATE	felbamate	TABLET;ORAL	207093-002	Apr 20, 2017	AB	RX	No	No
Ani Pharms	FELBAMATE	felbamate	TABLET;ORAL	202284-002	Nov 4, 2015	AB	RX	No	No

Expired US Patents for felbamate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	FELBATOL	felbamate	SUSPENSION;ORAL	020189-003	Jul 29, 1993	4,978,680
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	5,082,861
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	4,978,680
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993	5,082,861
Mylan Speciality Lp	FELBATOL	felbamate	SUSPENSION;ORAL	020189-003	Jul 29, 1993	5,082,861
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993	4,978,680

Felbamate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Felbamate

Introduction

Felbamate, marketed under the brand name Felbatol, is an antiepileptic drug used to control partial seizures and generalized seizures, particularly in patients with Lennox-Gastaut syndrome. Here, we delve into the market dynamics and financial trajectory of felbamate, highlighting its growth, challenges, and future projections.

Historical Context

Felbamate was first released in North America in 1993, marking the first new antiepileptic drug in 15 years. Initially, it was hailed for its efficacy and perceived lack of adverse effects compared to other antiepileptic drugs (AEDs)[3].

Market Growth

Despite its promising start, felbamate's market growth was significantly impacted by the discovery of serious side effects, including aplastic anemia and liver failure. These adverse effects led to a near-withdrawal from the market just a year after its release. However, it remained available for specific indications, particularly in children with Lennox-Gastaut syndrome who had failed other treatments[3].

Current Market Size and Projections

The global felbamate market has shown resilience and growth in recent years. As of 2023, the market size was substantial, and projections indicate a continued compound annual growth rate (CAGR) from 2024 to 2031. This growth is driven by the increasing prevalence of epilepsy and the need for effective treatment options[1][4].

Key Market Drivers

Increasing Prevalence of Epilepsy

The rising incidence of epilepsy globally is a significant driver for the felbamate market. As more patients are diagnosed, the demand for antiepileptic drugs, including felbamate, increases.

Unmet Medical Needs

Felbamate fills a critical gap in the treatment of epilepsy, especially for patients who do not respond to other AEDs. Its unique efficacy profile makes it a valuable option for these patients.

Regulatory Approvals and Clinical Trials

Felbamate's innovative clinical trial designs, including double-blind monotherapy trials and placebo-controlled trials in children with Lennox-Gastaut syndrome, have contributed to its market position. These trials have established its efficacy and safety in specific patient populations[3].

Market Challenges

Adverse Effects

The most significant challenge facing felbamate is its association with serious adverse effects such as aplastic anemia and liver failure. These risks necessitate careful patient monitoring and have limited its broader adoption[2][3].

Competition from Other AEDs

The antiepileptic drug market is highly competitive, with numerous other AEDs available. Felbamate must compete with these alternatives, many of which have more favorable safety profiles.

Regulatory Scrutiny

Given its history of adverse effects, felbamate is subject to stringent regulatory oversight. This scrutiny can impact its market dynamics and limit its use to specific patient groups.

Financial Trajectory

Revenue Trends

Despite the challenges, felbamate has maintained a stable revenue stream. The drug's niche market position and the lack of alternative treatments for certain patient groups ensure a consistent demand.

Cost and Pricing

The cost of felbamate can be a barrier for some patients. However, for those who benefit from it, the drug is often covered by insurance and healthcare programs, which helps in maintaining its financial viability.

Investment and Research

Pharmaceutical companies continue to invest in research and development to improve the safety and efficacy of felbamate. These investments are crucial for the long-term financial health of the drug.

Future Projections

Market Expansion

The global felbamate market is expected to expand, driven by the growing need for effective epilepsy treatments. Emerging markets, particularly in regions with increasing healthcare spending, are likely to contribute to this growth.

Safety Improvements

Ongoing research aims to mitigate the serious adverse effects associated with felbamate. Any significant improvements in safety could lead to broader adoption and increased market share.

Regulatory Environment

Changes in regulatory policies or the introduction of new safety guidelines could impact the market dynamics of felbamate. However, given its established niche, it is likely to remain a viable treatment option.

Key Takeaways

• Market Growth: The felbamate market is expected to grow due to the increasing prevalence of epilepsy and the drug's unique efficacy profile.
• Adverse Effects: Serious side effects remain a significant challenge, necessitating careful patient monitoring.
• Regulatory Scrutiny: Felbamate is subject to stringent regulatory oversight due to its safety profile.
• Financial Stability: The drug maintains a stable revenue stream despite its challenges.
• Future Projections: Market expansion and potential safety improvements are expected to influence the financial trajectory of felbamate.

FAQs

What is felbamate used for?

Felbamate is used to control partial seizures and generalized seizures, particularly in patients with Lennox-Gastaut syndrome who have failed other treatments[2].

What are the serious side effects of felbamate?

Felbamate can cause aplastic anemia and liver failure, which are serious and potentially fatal side effects[2][3].

Is felbamate available only by prescription?

Yes, felbamate is available only with a doctor's prescription due to its potential side effects and the need for careful patient monitoring[2].

How does felbamate compare to other antiepileptic drugs?

Felbamate has a unique efficacy profile but is associated with more serious adverse effects compared to some other AEDs. It is often used when other treatments have failed[3].

What are the future prospects for the felbamate market?

The felbamate market is expected to grow, driven by the increasing prevalence of epilepsy and ongoing research to improve the drug's safety and efficacy[1][4].

Sources

1. Global Felbamate Market Size, Scope And Forecast Report - Market Research Intellect
2. Felbamate (oral route) - Mayo Clinic
3. Felbamate - PubMed
4. Global Felbamate Market Report 2024 Edition, Market Size, Share ... - Cognitive Market Research