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		DISCN	Yes	No
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	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	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
Spain	2094145
Denmark	0491094
Austria	142492
European Patent Office	0491094	Felbamate pour le traitement du syndrom de Lennox-Gastaut (Felbamate for treating Lennox-Gastaut syndrome)
Greece	3021801
Germany	69028542

FELBATOL Market Analysis and Financial Projection

Last updated: February 10, 2026

What are the market dynamics surrounding FELBATOL (felbamate)?

FELBATOL, approved by the FDA in 1993 for refractory epilepsy, has experienced limited market penetration due to safety concerns. Its usage primarily targets patients with severe, treatment-resistant seizures. The drug's market is constrained by the availability of alternative therapies and strict monitoring requirements resultant from its serious adverse effects. The drug's sales peaked in the early 2000s but declined significantly following reports of hepatotoxicity and aplastic anemia.

Key factors influencing market dynamics include:

• Regulatory constraints: The FDA's restricted distribution program and black-box warning limit prescriber access. Tighter controls reduce prescriptions.
• Safety concerns: Reports of hepatic failure and blood dyscrasias prompted warnings and restricted use, hampering broad adoption.
• Alternative therapies: The introduction of newer antiepileptics with better safety profiles, such as levetiracetam and lacosamide, reduces FELBATOL’s market share.
• Off-label use: Limited due to safety concerns but persists in certain refractory epilepsy cases.

Market size remains small with annual sales estimates below $50 million globally, mostly within specialized epilepsy centers.

How has the financial trajectory of FELBATOL evolved over recent years?

FELBATOL's revenue declined sharply after its peak in the late 1990s and early 2000s. Major factors affecting revenue include:

• Market withdrawal and restrictions: The drug is not withdrawn but is prescribed cautiously, limiting high-volume sales.
• Limited manufacturing: The sole manufacturer, Acorda Therapeutics, ceased producing the drug in 2018 due to low demand and high safety management costs.
• Regulatory action: The FDA requires strict monitoring and Risk Evaluation and Mitigation Strategies (REMS), increasing distribution costs and limiting prescriber penetration.

Current financials indicate negligible sales, with estimates below $5 million annually in recent years. There is no significant pipeline activity or new formulations in development, further constraining revenue prospects.

What are the future prospects and potential shifts in the FELBATOL market?

FELBATOL faces a shrinking footprint because:

• Most epilepsy treatments have superior safety profiles.
• Regulatory restrictions remain stringent.
• The drug's indication is narrow, confined to refractory epilepsy.

Future shifts may include:

• Market niche: Continued, limited use within specialized epilepsy clinics, mainly for patients unresponsive to newer therapies.
• Regulatory review: No current proposals for reform or indication expansion.
• Potential repurposing: No active efforts or signals indicating exploration beyond existing indications.

FELBATOL's market is expected to remain small, declining further absent any major safety breakthrough or new data supporting broader use.

Key Takeaways

• Market size remains small, with annual sales below $50 million.
• Strict safety concerns and regulatory restrictions limit use.
• The manufacturing ceased as of 2018; no current production limits sales further.
• Competition from newer, safer drugs reduces FELBATOL's relevance.
• Future market prospects are limited to niche applications.

FAQs

1. Why did FELBATOL’s sales decline after the 2000s?
Due to reports of serious adverse effects such as hepatotoxicity and aplastic anemia. Regulatory agencies imposed restrictions, reducing prescriber dispensing.

2. Are there ongoing efforts to address safety concerns related to FELBATOL?
No significant safety reform efforts are publicly underway. The drug remains under strict REMS programs.

3. Can FELBATOL be used off-label for other conditions?
Off-label use exists but is limited due to safety profiles and regulatory restrictions.

4. Is there potential for FELBATOL market growth?
Limited. The drug serves a niche; no current plans for indication expansion or reformulation.

5. Will new formulations or derivatives be developed?
No announced development programs. The safety profile constrains future innovation.

References

1. U.S. Food and Drug Administration. (1993). FELBATOL (felbamate) prescribing information.
2. Acorda Therapeutics. (2018). Annual report and press release announcing discontinuation of FELBATOL manufacturing.
3. MarketLine. (2022). Epilepsy drugs market analysis.
4. FDA. (2017). REMS program for felbamate.
5. Epilepsy Foundation. (2021). Epilepsy drug treatment landscape.