FELBATOL Drug Patent Profile

Which patents cover Felbatol, and when can generic versions of Felbatol launch?

Felbatol is a drug marketed by Mylan Speciality Lp and is included in one NDA.

The generic ingredient in FELBATOL is felbamate. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the felbamate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Felbatol

A generic version of FELBATOL was approved as felbamate by AMNEAL PHARMS on September 13^th, 2011.

Summary for FELBATOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	1
Patent Applications:	4,890
Drug Prices:	Drug price information for FELBATOL
What excipients (inactive ingredients) are in FELBATOL?	FELBATOL excipients list
DailyMed Link:	FELBATOL at DailyMed

See drug prices for FELBATOL

Recent Clinical Trials for FELBATOL

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

Sponsor	Phase
National Institute of Mental Health (NIMH)	Phase 2

See all FELBATOL clinical trials

Pharmacology for FELBATOL

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

US Patents and Regulatory Information for FELBATOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	FELBATOL	felbamate	SUSPENSION;ORAL	020189-003	Jul 29, 1993	AB	RX	Yes	Yes
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993	AB	RX	Yes	No
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-002	Jul 29, 1993	AB	RX	Yes	Yes

Expired US Patents for FELBATOL

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
Mylan Speciality Lp	FELBATOL	felbamate	SUSPENSION;ORAL	020189-003	Jul 29, 1993
Mylan Speciality Lp	FELBATOL	felbamate	TABLET;ORAL	020189-001	Jul 29, 1993

International Patents for FELBATOL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0491094
Austria	142492
Greece	3021801
European Patent Office	0491094	Felbamate pour le traitement du syndrom de Lennox-Gastaut (Felbamate for treating Lennox-Gastaut syndrome)
Spain	2094145

Market Dynamics and Financial Trajectory for FELBATOL (Felbamate)

Last updated: July 31, 2025

Introduction

FELBATOL (felbamate) is an antiepileptic drug primarily used for refractory epilepsy and Lennox-Gastaut syndrome. Approved by the FDA in 1993, the drug has experienced fluctuating market relevance due to safety concerns and competition. Understanding its current market dynamics and financial trajectory requires a comprehensive review of regulatory status, therapeutic positioning, competitive landscape, and emerging opportunities.

Regulatory Status and Safety Profile

FELBATOL's market presence is significantly influenced by its safety profile. Its association with rare but severe adverse effects, including aplastic anemia and hepatic failure, prompted stringent post-marketing surveillance. The FDA issued boxed warnings, leading to restricted prescribing and monitoring requirements (FDA, 1994). These safety concerns diminish broader adoption, confining FELBATOL's use to specialists managing refractory cases under rigorous oversight.

The drug’s restricted prescribing status limits volume expansion, especially in markets with strict regulatory environments like North America and Europe. Nonetheless, its unique efficacy in certain refractory epilepsies sustains demand within niche segments. The regulatory landscape continues to evolve, with some jurisdictions tightening controls, while others maintain relaxed restrictions owing to clinical need.

Market Size and Disease Segments

Epilepsy Landscape

Epilepsy affects approximately 50 million individuals globally, with a subset suffering from drug-resistant forms (WHO, 2021). Lennox-Gastaut syndrome (LGS), a severe epileptic encephalopathy, frequently warrants off-label use of aggressive pharmacotherapy, including FELBATOL.

Target Population for FELBATOL

FELBATOL's ideal candidates are patients unresponsive to first-line antiepileptics and who are monitored closely for adverse events. The niche nature caps its total addressable market but ensures sustained, if limited, revenue streams among refractory epilepsy treatments.

Market Penetration and Limitations

Due to its safety profile, FELBATOL’s utilization is predominantly restricted to specialized epilepsy centers. This limits volume but ensures premium pricing due to the high clinical value and the complexity of therapy management.

Competitive Landscape

Alternative Therapies

The market for refractory epilepsy therapies is populated with newer, often better-tolerated drugs, such as:

• Cannabidiol (Epidiolex): Approved for LGS, offers a different safety profile.
• Fenfluramine: Recently approved with promising efficacy.
• Stiripentol and Clobazam: Often used adjunctively.

These alternatives challenge FELBATOL’s market share, particularly because they may have more favorable safety and tolerability profiles. However, FELBATOL’s unique efficacy in specific refractory cases retains some niche importance.

Market Entry Barriers for New Competitors

The high regulatory standards, especially safety monitoring, act as barriers for new entrants targeting the same niche. Commercially, the need for specialized prescribing limits mass-market penetration, protecting FELBATOL’s current position among certain patient cohorts.

Financial Trajectory

Revenue Trends

Historically, FELBATOL experienced modest, stable revenue driven by niche demand. Its revenues plateaued as safety concerns limited broader adoption, and competitors introduced drugs with improved safety profiles.

Pricing and Reimbursement

Given its specialized use, FELBATOL commands premium pricing, especially in markets with high healthcare standards. Reimbursement rates are contingent upon strict monitoring requirements, which may elevate overall treatment costs.

Future Revenue Potential

The financial outlook hinges on several factors:

• Regulatory Changes: Any relaxation or tightening of safety restrictions could expand or contract market size.
• Emerging Alternatives: Introduction of new drugs with superior safety profiles might cannibalize FELBATOL’s niche.
• Market Expansion: Off-label use in other refractory epilepsies may marginally boost sales but remains limited due to safety concerns.

Impact of Market Trends

Growing emphasis on personalized medicine and safer therapeutics may lead to a decline in FELBATOL’s market share. Conversely, as research continues into severe epilepsy subsets, incremental opportunities could emerge for FELBATOL’s targeted application, especially if safety measures prove effective.

Recent Developments and Market Opportunities

Research into optimizing safety monitoring and adjunctive use broadens potential for FELBATOL’s reevaluation. There is increasing interest in developing formulations or protocols that mitigate risks, which could revive its market relevance.

Additionally, some pharmaceutical companies are exploring drug repurposing and label expansions to reach broader patient populations. For instance, investigational use in autoimmune or neurodegenerative conditions remains a theoretical avenue, though no substantial breakthroughs are currently reported.

Conclusion

FELBATOL occupies a highly specialized niche within the refractory epilepsy treatment landscape. Its market dynamics are predominantly shaped by stringent safety constraints, with limited expansion potential due to emerging therapies offering better tolerability. Nonetheless, its clinical efficacy in specific populations sustains its relevance and offers incremental financial opportunities amid a competitive environment. The future trajectory will depend heavily on regulatory shifts, advancements in safety management, and the broader evolution of epilepsy therapeutics.

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Key Takeaways

• Restricted Use & Safety Concerns: FELBATOL's market is constrained by significant safety warnings, limiting its widespread adoption.
• Niche Market Positioning: Its primary market comprises specialized epilepsy centers managing refractory cases, ensuring steady but limited revenue.
• Competitive Challenges: Newer therapies with better safety profiles threaten FELBATOL’s market share, although niche efficacy sustains its relevance.
• Regulatory & Research Opportunities: Potential exists for regulatory reevaluation or safety improvements to expand its market, especially if targeted at specific refractory populations.
• Financial Outlook: Revenue is expected to remain stable within its niche but unlikely to experience significant growth unless safety and regulatory hurdles are addressed.

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FAQs

1. What are the primary safety concerns associated with FELBATOL?
FELBATOL has been linked to rare but severe adverse effects, including aplastic anemia and hepatic failure, which necessitate meticulous patient screening and monitoring.

2. Can FELBATOL be used outside of the United States?
Use varies globally; some countries impose similar restrictions, while others may have more lenient regulations. Its off-label use remains restricted to specialist centers under strict protocols.

3. Are there any ongoing clinical trials to improve FELBATOL’s safety profile?
While limited, some research explores optimized dosing and monitoring protocols. However, no major trials aim to significantly alter its safety profile at this time.

4. How does FELBATOL compare to newer epileptic treatments?
Newer agents like cannabidiol and fenfluramine generally offer better safety and tolerability, making FELBATOL suitable only for specific refractory cases.

5. What potential strategies could extend FELBATOL’s market lifespan?
Developing safer formulations, improving safety monitoring, and expanding approved indications under regulatory supervision could help sustain its niche role.

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Sources

1. U.S. Food and Drug Administration. (1994). FELBATOL (felbamate) Product Information.
2. World Health Organization. (2021). Epilepsy Fact Sheet.
3. International Epilepsy Bureau. (2022). Refractory Epilepsy Treatment Landscape.