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
Federal University of 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		DISCN	No	No
Novitium Pharma	FELBAMATE	felbamate	SUSPENSION;ORAL	211333-001	May 31, 2019	AB	RX	No	No
Ani Pharms	FELBAMATE	felbamate	TABLET;ORAL	202284-001	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
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Felbamate

Last updated: July 28, 2025

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Introduction

Felbamate, a potent anticonvulsant, has historically occupied a niche in the treatment of refractory epilepsy. Approved initially in the late 1980s, its market dynamics have evolved through regulatory challenges, safety concerns, and emerging therapeutic alternatives. Understanding its financial trajectory involves analyzing the drug’s clinical profile, regulatory landscape, patent lifecycle, market demand, and competitive positioning within anti-epileptic therapies.

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Pharmacological Profile and Therapeutic Indications

Felbamate (marketed under brand names such as Felbatol) is primarily used to manage severe, treatment-resistant epilepsy forms, including Lennox-Gastaut syndrome and partial seizures. Its mechanism involves modulation of NMDA receptor activity and enhancement of GABAergic transmission. Despite its efficacy, its use is constrained by significant adverse effects—most notably, aplastic anemia and hepatotoxicity—necessitating stringent monitoring and limiting widespread adoption [1].

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Regulatory Landscape and Safety Concerns

The early 1990s marked a turning point when reports of fatalities associated with felbamate-induced aplastic anemia prompted the FDA to restrict its use in the United States. Its approval was limited to severe, refractory cases under a restrictive medication guide. Similar concerns led to reduced utilization globally, impacting the drug’s market potential. The regulatory environment continues to influence its commercial viability, with safety monitoring and prescribing restrictions serving as barriers [2].

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Market Demand and Clinical Adoption

Despite safety concerns, felbamate remains a valuable option for patients unresponsive to other anticonvulsants. Prescribers weigh its potent efficacy against its toxicity risks, often reserving it as a last-line therapy. The small, specialized patient population limits volume but sustains steady demand among neurologists treating refractory epilepsies. However, increasing availability and approval of newer agents—such as cannabidiol derivatives and other NMDA antagonists—pose competitive threats that could erode felbamate’s market share.

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Patent Status and Formulation Exclusivity

Felbamate’s patent landscape has significantly influenced its financial trajectory. Originally patented in the 1980s, patent protections have long expired, leading to generic manufacturing and price erosion. Consequently, profit margins have diminished, especially in regions where generics dominate. No recent patent extensions or formulation innovations are evident, constraining revenue growth and investment in derivative research [3].

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Competitive Landscape in Antiepileptic Drugs

The anti-epileptic market is highly competitive, with over 30 FDA-approved drugs. The arrival of drugs with better safety profiles and broader indications has shifted market preferences away from felbamate. Agents such as levetiracetam, lamotrigine, and newer options like cannabidiol (Epidiolex) provide comparable efficacy with fewer serious adverse events. This competitive pressure diminishes felbamate's market share and constrains revenue generation.

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Financial Trajectory and Market Outlook

Given the safety profile limitations and patent expirations, the financial trajectory of felbamate is characterized by a plateau or decline in sales. Its niche status confines significant growth opportunities absent safety improvements or new formulations. Nonetheless, continued demand persists in specialist clinics, especially where alternatives are ineffective or contraindicated.

The development pipeline for felbamate itself is virtually nonexistent; no recent reformulations or combination therapies are in advanced stages. As a result, revenue stability relies heavily on ongoing generic sales rather than innovation-driven growth.

Market forecasts suggest limited upside in the upcoming decade, with total sales remaining modest—particularly in mature markets such as the U.S. and Europe. Emerging markets may present marginal growth avenues owing to increasing epilepsy prevalence and limited access to newer therapies, but price-sensitive healthcare systems could further suppress profitability.

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Emerging Opportunities and Challenges

Future prospects for felbamate hinge on safety profile optimization. Innovative delivery routes, such as targeted formulations reducing systemic toxicity, or combination therapies lowering required doses, could rekindle interest. Additionally, expanding indications to other neurological disorders or leveraging biomarkers for personalized medicine might unlock incremental revenues.

Conversely, regulatory hurdles remain formidable, especially in jurisdictions with stringent safety standards. Patent expiries further limit pricing power, compelling manufacturers to adopt cost-centric strategies.

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Key Market Drivers

• Refractory Epilepsy Treatment Needs: Persistent demand among specific patient subsets tolerating limited options.
• Safety Monitoring Infrastructure: Regulatory requirements that constrain broad use but keep the drug relevant in specialized settings.
• Competitive Innovation: Emergence of novel therapeutics with enhanced safety profiles diminishes felbamate’s attractiveness.
• Generic Market Penetration: Widespread availability, reducing profit margins and investment incentives.

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Conclusion

Felbamate’s market dynamics are shaped by its potent efficacy in refractory epilepsy juxtaposed against significant safety concerns and patent expiry-driven generic competition. Its financial trajectory is currently characterized by limited growth prospects, with steady but declining revenues confined to specialized medical niches. Future opportunities require innovation in safety and formulation, yet regulatory and competitive pressures pose substantial hurdles.

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Key Takeaways

• Niche Market Focus: Felbamate remains relevant primarily among neurologists treating treatment-resistant epilepsies, but broad adoption is hindered by safety concerns.
• Patent Expiry Impact: The absence of patent protection has led to price erosion and limited revenue growth.
• Competitive Displacement: Newer, safer anticonvulsants and emerging therapies threaten felbamate’s share of the anti-epileptic market.
• Innovation Necessities: Future growth hinges on safety improvements or new delivery mechanisms; current pipeline activity is minimal.
• Regional Variations: Emerging markets may sustain marginal demand, but price sensitivity limits profitability.

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FAQs

Q1: Why has felbamate’s use declined globally since its initial approval?
A1: Safety concerns—mainly aplastic anemia and hepatotoxicity—led regulators to impose strict restrictions, limiting its use to refractory cases, thereby reducing prescribing rates worldwide.

Q2: Are there ongoing developments to improve felbamate’s safety profile?
A2: Currently, no significant reformulations or combination strategies targeting safety enhancements are publicly underway; progress depends on pharmaceutical innovation and regulatory approvals.

Q3: How does the patent status influence felbamate’s market and revenue?
A3: Patent expiration resulted in generic availability, driving down prices and limiting profit margins, which reduces incentives for manufacturers to invest in new formulations or marketing.

Q4: What are the main competitive threats to felbamate in the epilepsy market?
A4: Safer, more effective anticonvulsants—like levetiracetam, lamotrigine, and cannabidiol—offer similar efficacy with fewer adverse effects, shifting market preference away from felbamate.

Q5: Is felbamate’s market expected to grow in the future?
A5: No significant growth is forecasted; sales are expected to remain stable or decline slightly, confined mainly to niche markets with limited expansion potential.

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Sources

[1] French JA. Pharmacology of felbamate. Epilepsia. 1993;34(Suppl 5):S44–S50.
[2] U.S. Food and Drug Administration. Felbamate (Felbatol) prescribing information. 1995.
[3] GlobalData. Anti-epileptic Drugs Market Analysis. 2022.