FYCOMPA Drug Patent Profile

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

Fycompa is a drug marketed by Catalyst Pharms and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and one patent family members in thirty-three countries.

The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the perampanel profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fycompa

A generic version of FYCOMPA was approved as perampanel by TEVA PHARMS USA INC on May 23^rd, 2025.

Summary for FYCOMPA

International Patents:	101
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	25
Patent Applications:	749
Drug Prices:	Drug price information for FYCOMPA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FYCOMPA
What excipients (inactive ingredients) are in FYCOMPA?	FYCOMPA excipients list
DailyMed Link:	FYCOMPA at DailyMed

See drug prices for FYCOMPA

Recent Clinical Trials for FYCOMPA

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

Sponsor	Phase
Advanced Research Center (ARC)	PHASE1
Aya Mohammed Abdel Magid Abdel Hamid	PHASE1
Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals	PHASE1

See all FYCOMPA clinical trials

Pharmacology for FYCOMPA

Drug Class	Noncompetitive AMPA Glutamate Receptor Antagonist
Mechanism of Action	AMPA Receptor Antagonists Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inhibitors UGT1A9 Inhibitors UGT2B7 Inhibitors

Paragraph IV (Patent) Challenges for FYCOMPA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FYCOMPA	Oral Suspension	perampanel	0.5 mg/mL	208277	1	2022-12-20
FYCOMPA	Tablets	perampanel	2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg	202834	2	2016-10-24

US Patents and Regulatory Information for FYCOMPA

FYCOMPA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016	AB	RX	Yes	Yes	6,949,571		Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012	AB	RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	AB	RX	Yes	No	8,772,497			Y

Expired US Patents for FYCOMPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016	6,949,571

EU/EMA Drug Approvals for FYCOMPA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eisai GmbH	Fycompa	perampanel	EMEA/H/C/002434Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.	Authorised	no	no	no	2012-07-23

International Patents for FYCOMPA

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100904011
Poland	1772450
Japan	3922368

Supplementary Protection Certificates for FYCOMPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1764361	C 2013 025	Romania		PRODUCT NAME: PERAMPANEL3-(2-CIANOFENIL)-5-(2-PIRIDIL)-1-FENIL-1,2-DIHIDROPIRIDIN-2-ONA; NATIONAL AUBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/776/001 - EU/1/12/776/023; DATE OF FIRST AUTHORISATION IN EEA: 20120723 THORISATION NUMBER: EU/1/12/776/001 - EU/1/12/776/023; DATE OF NATIONAL AUTHORISATION: 20120723; NUM
1764361	PA2013017	Lithuania		PRODUCT NAME: PERAMPANELUM; REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016, 2012 07 23 EU/1/12/776/017 - EU1/12/776/023 20121029
1300396	CA 2012 00052	Denmark

Market Dynamics and Financial Trajectory for FYCOMPA

Last updated: July 27, 2025

Introduction

FYCOMPA (perampanel), developed by Eisai Inc., is a once-daily oral anticonvulsant approved primarily for the adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 12 years and older. Since its approval in 2012 by the FDA, FYCOMPA has marked its presence within the complex pharmaceutical landscape of epilepsy management. This analysis evaluates the key market dynamics influencing FYCOMPA and projects its financial trajectory amid evolving competitive, regulatory, and clinical environments.

Market Landscape for Epilepsy Pharmacotherapy

Epilepsy affects approximately 50 million individuals globally, making it a significant market segment for antiepileptic drugs (AEDs) [1]. The existing market comprises multiple therapeutic options, including traditional AEDs (e.g., phenytoin, valproate), newer-generation drugs (e.g., levetiracetam, lamotrigine), and recently approved agents like FYCOMPA. The demand for innovative therapies, especially for treatment-resistant cases, sustains interest and competition within this domain.

Mechanism of Action and Differentiation

FYCOMPA’s anticonvulsant activity relies on selective antagonism of AMPA-type glutamate receptors, mediating excitatory neurotransmission in the central nervous system. This unique mechanism has positioned FYCOMPA as a potentially efficacious option for patients unresponsive to other AEDs. However, its adverse effect profile, primarily dizziness, somnolence, and behavioral effects, influences its clinical adoption [2].

Market Dynamics

Regulatory and Clinical Positioning

FYCOMPA received initial FDA approval in 2012, followed by subsequent approvals in Europe and other markets, expanding its regional footprint. Nonetheless, the drug's positioning faces challenges from newer agents with favorable safety profiles or broader indications. Regulatory agencies continue to scrutinize safety signals related to behavioral adverse effects, which influence prescribing patterns.

Competitive Environment

FYCOMPA competes against established AEDs such as levetiracetam, lamotrigine, and newer agents like brivaracetam. Its distinct mechanism offers a niche, particularly for refractory cases, but limited broad-spectrum efficacy restricts market penetration. Additionally, oral novel formulations and combination therapies potentially encroach on FYCOMPA’s segment.

Market Penetration and Prescribing Trends

Despite initial enthusiasm, FYCOMPA’s market share remains modest relative to dominant AEDs. Market penetration is further constrained by clinicians’ safety concerns and the modest efficacy demonstrated in some clinical trials. Payers' reimbursement policies and formulary placements critically impact prescription volumes, especially in cost-sensitive settings.

Pricing and Reimbursement Dynamics

Pricing strategies for FYCOMPA are influenced by its clinical niche, competitive pressures, and regional healthcare reimbursement mechanisms. While priced higher than generic AEDs, its cost-effectiveness relies heavily on clinical benefits for refractory patient populations. Negotiations with insurance providers and health authorities dictate accessible pricing and reimbursement levels, affecting revenue streams.

Financial Trajectory and Revenue Projections

Historical Revenue Performance

Since launch, FYCOMPA’s revenue has shown incremental growth but remains below initial forecasts, reflecting limited market uptake. For fiscal years 2018–2022, fiscal reports indicate revenues in the low hundreds of millions USD annually, with slight fluctuations attributable to regulatory events and competitive pressures [3].

Growth Drivers

• Expansion into New Indications: Pending approvals for additional indications, such as Lennox-Gastaut syndrome, could broaden the market size.
• Geographic Expansion: Increasing market presence in emerging markets with growing epilepsy prevalence offers significant growth potential.
• Combination Therapy Potential: Exploring FYCOMPA’s role within polytherapy regimens may enhance its utilization.

Risks and Challenges

• Safety Signal Acceptance: Behavioral adverse effects may limit maximum dosing, reducing efficacy and prescribing.
• Market Competition: The aggressive pipeline of epilepsy agents threatens FYCOMPA’s market share.
• Pricing Reforms: Increased pressure for biosimilar or generic alternatives can depress prices.

Financial Outlook

Given current trends, FYCOMPA’s revenues are projected to grow modestly over the next 3–5 years, contingent on regulatory approvals, safety profile acceptance, and geographic expansion. An optimistic scenario—marked by successful indication expansion and strong clinician adoption—could see revenues approaching $300–400 million annually by 2027. Conversely, market saturation and safety concerns could constrain growth, maintaining revenues within recent levels or inducing slight declines.

Strategic Positioning and Market Opportunities

• Focused Patient Subsets: Target refractory epilepsy populations with limited treatment options.
• Combination Therapy Research: Clinical trials assessing FYCOMPA’s efficacy as part of multi-drug regimens could unlock new market segments.
• Post-Marketing Surveillance: Emphasizing safety profile management to mitigate behavioral risks and improve clinician confidence.

Conclusion

FYCOMPA’s market dynamics reflect the complexities of epilepsy therapeutics, balancing its mechanistic uniqueness against competitive, safety, and regulatory hurdles. Financial prospects hinge on strategic expansion, safety profile optimization, and navigating evolving healthcare reimbursement landscapes. As the epilepsy market continues to evolve, FYCOMPA’s trajectory will primarily depend on its ability to demonstrate superior clinical benefits within a constrained safety framework and to adapt to regional market nuances.

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Key Takeaways

• FYCOMPA remains a niche player in the epilepsy drug market, primarily targeting treatment-resistant cases.
• Market penetration is limited by safety concerns, especially behavioral side effects, and stiff competition from established AEDs.
• Revenue growth prospects are moderate, with potential gains via indication expansion and geographic penetration, especially in emerging markets.
• Strategic initiatives focusing on safety profile management and combination therapy research are critical for enhancing FYCOMPA’s market presence.
• Ongoing regulatory scrutiny and payer negotiations continue to influence FYCOMPA’s financial trajectory.

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FAQs

1. What are the primary therapeutic uses of FYCOMPA?
FYCOMPA is approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 12 and above.

2. How does FYCOMPA differ from other AEDs?
It uniquely antagonizes AMPA receptors, offering a different mechanism of action that may benefit refractory epilepsy cases.

3. What are the main safety concerns associated with FYCOMPA?
Behavioral effects, dizziness, somnolence, and irritability are notable adverse effects that can impact long-term adherence and prescribing.

4. What regions show the highest growth potential for FYCOMPA?
Emerging markets in Asia-Pacific and Latin America present opportunities due to increasing epilepsy prevalence and expanding healthcare infrastructure.

5. What are the key factors influencing FYCOMPA’s revenue in the next five years?
Regulatory approvals for new indications, adoption levels by clinicians, safety profile management, and regional market expansion will determine revenue growth.

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References

[1] World Health Organization. (2019). Epilepsy Fact Sheet.
[2] U.S. Food and Drug Administration. (2012). FDA approves Fycompa for epilepsy.
[3] Eisai Inc. Fiscal Year Reports, 2018–2022.