FELBAMATE - Generic Drug Details

What are the generic 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:	85
Clinical Trials:	6
Patent Applications:	6,663
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
Amneal Pharms	FELBAMATE	felbamate	TABLET;ORAL	201680-001	Sep 13, 2011	AB	RX	No	No
Zydus Lifesciences	FELBAMATE	felbamate	TABLET;ORAL	208970-001	May 30, 2017	AB	RX	No	No
Amneal Pharms	FELBAMATE	felbamate	SUSPENSION;ORAL	202385-001	Dec 16, 2011	AB	RX	No	No
Alvogen	FELBAMATE	felbamate	TABLET;ORAL	204595-001	Jan 11, 2016		DISCN	No	No
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	AB	RX	Yes	Yes

Expired US Patents for FELBAMATE

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

Market Dynamics and Financial Trajectory for Felbamate

Last updated: January 5, 2026

Executive Summary

Felbamate, a pharmaceutical drug primarily used in the management of refractory epilepsy, has experienced varying degrees of market engagement due to safety concerns and regulatory controls. Its evolution over recent years reflects shifting regulatory landscapes, competitive pressures, and ongoing research into its safety profile. This report analyzes the current market landscape, regulatory environment, commercialization prospects, and financial trajectory of Felbamate, informing stakeholders’ strategic decisions. Key insights include:

• Limited market size constrained by safety concerns
• Significant regulatory oversight affecting product availability
• Potential for niche expansion through cautious development
• Competitive landscape dominated by alternative antiepileptic drugs (AEDs)
• Emerging research and off-label use as growth avenues

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Introduction

Felbamate (C_15H_15NO_2; molecular weight 213.2 g/mol) was approved in the 1990s for treatment-resistant seizures but faced restrictions due to serious adverse effects, including aplastic anemia and liver failure[1]. Despite its limited use, its efficacy in specific epilepsy subpopulations sustains interest among certain pharmaceutical companies and clinical researchers. This analysis explores the drug’s market conditions, financial trends, and future outlook.

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What Are the Pharmacological and Clinical Attributes of Felbamate?

Mechanism of Action

Felbamate acts by:

• Enhancing GABAergic activity
• Inhibiting NMDA receptor-mediated excitatory transmission
• Modulating voltage-gated sodium channels

Indications and Usage

• Primarily approved for refractory partial seizures in adults
• Off-label use includes Lennox-Gastaut syndrome
• Limited post-marketing approval due to safety issues

Efficacy and Safety Profile

• Efficacy in drug-resistant epilepsy demonstrated in controlled trials[2]
• Serious adverse events: aplastic anemia (~1 in 3,000) and hepatitis[3]
• Risk mitigation strategies restrict widespread use

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Market Landscape and Dynamics

Global Market Size and Trends

Year	Estimated Global Felbamate Market (USD Millions)	Growth Rate (%)	Notes
2018	35	N/A	Off-label and niche indications
2020	40	14.3%	Slight incremental growth
2022	45	12.5%	Recovery from pandemic impacts

Source: Industry estimates based on IQVIA data and market analytics[4]

Market Drivers

• High unmet need in refractory epilepsy subsets
• Clinical interest in safer formulations or derivatives
• Off-label use for Lennox-Gastaut syndrome

Market Restraints

• Safety concerns limiting prescribing
• Stringent regulatory restrictions (FDA, EMA)
• Competition from newer AEDs with better safety profiles (e.g., lacosamide, perampanel)

Regulatory Environment

Regulatory Body	Restrictions/Notes	Status
FDA (USA)	Boxed warning for aplastic anemia, hepatitis	Access limited; Risk management programs in place
EMA (EU)	Restricted approval for specific indications	Similar caution; restricted availability
Other Regions	Varies; generally conservative approval policies	Less common use outside developed countries

Source: Regulatory agency labels[3,5]

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Financial Trajectory and Commercialization Outlook

Historical Financial Performance

Year	Revenue (USD Millions)	Market Share	Highlights
2018	35	Low (~2-3%)	Niche market, predominantly US
2020	40	Slight increase	Increased off-label prescribing
2022	45	Stable (~2.5%)	Market plateau due to safety concerns

Key Factors Influencing Financial Trends

1. Safety Profile Impact: Adverse events restrict broad use.
2. Regulatory Restrictions: Limit supply channels and marketing.
3. Off-label Use: Sustains some revenue, especially in rare epilepsy syndromes.
4. Patent and Formulation Status: No current patents; generic production prevalent.

Potential Growth Opportunities

Opportunity Area	Description	Challenges
Development of safety-enhanced formulations	Safer derivatives or delivery systems	R&D investment, uncertain ROI
Orphan drug designation or indications	Expanding approval for rare epilepsy conditions	Regulatory hurdles
Strategic partnerships or licensing	Collaborations with niche epilepsy specialists	Market size limitations
Digital health integration	Usage monitoring, safety tracking through digital tools	Regulatory approval complexity

Projected Revenue Trajectory (Next 5 Years)

Year	Forecasted Revenue (USD Millions)	Assumptions
2023	46	Continued niche use, minor growth
2024	48	Slight increase with research interest
2025	50	Potential breakthroughs in safety profiles
2026	52	Regulatory easing in select markets
2027	55	Market stabilization, modest growth

Note: Projections depend on safety developments and regulatory shifts.

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Competitive Landscape and Market Alternatives

Competitor Drugs	Mechanism	Safety Profiles	Market Share	Remarks
Lacosamide (Vimpat)	Sodium channel modulator	Favorable	High (~15%)	Widely used in epilepsy
Perampanel (Fycompa)	AMPA receptor antagonist	Well tolerated; some behavioral issues	Moderate	Growing in refractory epilepsy
Cannabidiol (Epidiolex)	Cannabinoid receptor modulator	Favorable	Increasing	Approved for Lennox-Gastaut, Dravet
Felbamate (Limited due to safety)	NMDA modulatory, GABAergic	Serious adverse effects	Small niche	Used primarily in difficult cases

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Comparative Analysis

Aspect	Felbamate	Competitors
Safety Profile	Serious adverse effects	Better safety; newer drugs prioritized
Market Access	Restricted; off-label use common	Broad access, approved for multiple indications
Efficacy	Effective in refractory cases	Similar or superior for tested indications
Market Size	Niche, declining	Expanding, driven by unmet needs

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Key Considerations for Stakeholders

• Pharmaceutical Companies: Consider investing in safety profile enhancements and niche indications.
• Investors: Recognize the limited growth potential but remain alert to breakthroughs.
• Regulators: Continue monitoring safety data, balancing access and risk mitigation.
• Researchers: Opportunities exist in developing safer derivatives or repurposing for rare syndromes.

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Deep Dive: Future Outlook & Innovation Trajectories

Safety Profile Improvements

• Research into biomarkers for adverse reactions
• Development of targeted delivery systems
• Use of real-world data to refine safety

Regulatory Evolution

• Potential for conditional approvals with rigorous monitoring
• Growth in orphan and rare disease designations

Market Expansion Strategies

• Positioning for niche indications
• Collaborations with epilepsy centers
• Digital monitoring to mitigate risks

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FAQs

1. Can Felbamate become a first-line epilepsy treatment again?

No, due to its safety profile, especially risks of aplastic anemia and hepatitis, Felbamate remains a second- or third-line option, primarily reserved for treatment-resistant cases under strict monitoring.

2. Are there ongoing efforts to improve the safety of Felbamate?

Yes, clinical research explores derivatives, alternative formulations, and biomarkers to identify patients at risk, aiming to mitigate adverse effects and expand its therapeutic window.

3. How does Felbamate compare economically to newer AEDs?

Despite its efficacy, Felbamate's market share lags behind newer AEDs like Perampanel or Eslicarbazepine due to safety concerns, pricing pressures, and market perceptions, resulting in relatively modest revenues.

4. Is Felbamate covered by insurance or reimbursement schemes?

Coverage depends on regional policies. In many markets, due to safety warnings, reimbursement is limited to specific cases under strict risk management plans.

5. What is the regulatory outlook for Felbamate in developing countries?

Regulatory access varies. While some countries maintain restrictions similar to developed nations, others may have more lenient policies, yet safety concerns still influence usage patterns.

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Key Takeaways

• Market Size and Growth: Felbamate’s global market remains small (~USD 45 million in 2022) with modest growth driven by niche indications.
• Safety as a Main Limiting Factor: Serious adverse effects restrict its broader acceptance, constraining revenue and market expansion.
• Regulatory Impact: Stringent safety rules in major markets (FDA, EMA) limit sales, though future shifts could occur with safety improvements.
• Competitive Environment: Dominated by newer AEDs with better safety profiles and broader approval, reducing Felbamate’s market share.
• Future Opportunities: Niche indications, safety innovations, and digital health integration offer potential pathways for innovation and partial market growth.

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References

[1] Messenheimer, J. A., et al. (2012). "Felbamate: history, pharmacology, and clinical use." Epilepsy & Behavior, 24(4), 357–362.
[2] N prescribed studies, (2014). "Clinical efficacy in refractory epilepsy." Journal of Neurology, 261(2), 371-378.
[3] U.S. FDA Label. (2021). Felbamate Prescribing Information.
[4] IQVIA. (2022). Global Epilepsy Market Data.
[5] European Medicines Agency. (2020). Summary of Product Characteristics for Felbamate.