FYCOMPA Drug Patent Profile

When do Fycompa patents expire, and what generic alternatives are available?

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

This drug has fifty-three patent family members in twenty-eight countries.

The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Five 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:	53
US Patents:	1
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
Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals	PHASE1
Advanced Research Center (ARC)	PHASE1
Aya Mohammed Abdel Magid Abdel Hamid	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 one 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				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	AB	RX	Yes	Yes				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	AB	RX	Yes	No				Y

Expired US Patents for FYCOMPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012

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	20070094995
World Intellectual Property Organization (WIPO)	0196308
Brazil	PI0510254	cristal de composto de 1,2-diidropiridina e método para produzir o mesmo

Supplementary Protection Certificates for FYCOMPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1300396	92113	Luxembourg		PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
1300396	SPC/GB12/057	United Kingdom		PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
1300396	420	Finland

Market Dynamics and Financial Trajectory of FYCOMPA (Perampanel)

Last updated: February 19, 2026

What is FYCOMPA and its approved indications?

FYCOMPA (perampanel) is an antiepileptic drug developed by Eisai. It is approved by the U.S. Food and Drug Administration (FDA) for:

• Adjunctive treatment of partial-onset seizures in patients aged 12 years and older.
• Primary generalized tonic-clonic seizures in patients aged 12 years and older.

In Europe, it carries similar indications. The drug functions as a non-competitive AMPA receptor antagonist, reducing excitatory neurotransmission.

What are the key market drivers for FYCOMPA?

1. Growing prevalence of epilepsy

Worldwide epilepsy prevalence exceeds 50 million, with an annual incidence of approximately 50 per 100,000 people. The increasing diagnosis rates in the U.S. and Europe support demand. The unmet need for effective, tolerable treatments sustains market interest.

2. Expanded approval and orphan drug status

In 2021, the FDA granted orphan drug designation for certain rare epileptic syndromes, potentially extending exclusivity periods. Expanded approvals for additional indications can boost sales potential.

3. Competitive landscape

FYCOMPA faces competition from drugs like levetiracetam, lamotrigine, and cannabidiol (Epidiolex). It offers a unique mechanism of action, which may appeal to patients resistant to traditional therapies.

4. Pricing and reimbursement trends

Reimbursement policies in the U.S. and Europe favor newer, branded therapies for refractory epilepsy. High pricing, especially in Health Maintenance Organizations (HMOs) and national health systems, influences revenue growth.

How does FYCOMPA perform financially?

Revenue trends

• 2021: Approximately $333 million in global sales (Eisai Annual Report).
• 2022: Sales increased to about $365 million, reflecting new indications and broader market penetration.

Geographic breakdown

Region	2021 Revenue	2022 Revenue	Year-over-Year Growth
U.S.	$150 million	$165 million	10%
Europe	$105 million	$115 million	9.5%
Rest of World	$78 million	$85 million	8.9%

Market share

In 2022, FYCOMPA holds approximately 7-8% of the global add-on epilepsy treatment market, trailing behind levetiracetam (20%) and lamotrigine (15%).

What are the factors influencing FYCOMPA’s future financial trajectory?

1. Pipeline development

Eisai is exploring additional indications, including pediatric and rare epilepsy syndromes. Positive trial results could expand revenue streams.

2. Competitive pressures

Oral drugs like cannabidiol have gained traction, especially for drug-resistant epilepsy. Patent expirations for some competitors could favor FYCOMPA’s market position if the drug maintains exclusivity through 2030.

3. Pricing pressures

Healthcare cost containment policies could lead to price negotiations, impacting margins. The drug’s premium positioning may face challenges from biosimilar and cheaper alternatives.

4. Regulatory changes

Any new restrictions on opioid-like medications or changes in epilepsy treatment guidelines could alter demand.

5. Market penetration

Eisai’s ongoing academic and clinician outreach boosts prescriber use. Expansion into emerging markets offers growth opportunities, given increasing epilepsy awareness.

How do recent policies impact FYCOMPA’s commercial prospects?

• The FDA's REMS program for seizure medications requires prescribers to undergo specialized training, potentially limiting access.
• Countries adopting real-world evidence (RWE) requirements for drug approval may delay market expansion but could also validate FYCOMPA's efficacy, supporting reimbursement.
• Negotiation of Pricing and Reimbursement: In major markets, payers are demanding more data on cost-effectiveness. Eisai must demonstrate value to sustain premium pricing.

Summary of key financial projections

Year	Estimated Revenue	Notes
2023	$390 - $410 million	Slight growth driven by new indications and market expansion.
2024	$420 - $440 million	Continued expansion; potential impact from increased competition.
2025 and beyond	Potential plateau or decline	Facing patent expirations and increased biosimilar or alternative competition, unless pipeline offsets decline.

Final analysis

Eisai’s FYCOMPA revenues are expected to grow modestly over the next two years. Major growth drivers include expanded indications and emerging markets. However, competitive pressures, reimbursement negotiations, and patent expiration risks temper long-term growth prospects.

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Key Takeaways

• FYCOMPA generated $365 million globally in 2022.
• Growth driven mainly by increased market penetration and expanded indications.
• Faces competition from newer therapies, including cannabidiol.
• Patent protection through 2030 supports revenue stability.
• Pipeline developments and emerging markets are critical for future growth.

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Frequently Asked Questions

1. Is FYCOMPA’s patent protection secure?

Until at least 2030, following its 2013 U.S. patent filing. Patent cliffs could occur post-2030, risking generic entry.

2. How does FYCOMPA compare price-wise to competitors?

It commands a premium price, approximately 20-30% higher than older antiepileptics. Pricing strategies depend heavily on payer negotiations and regional policies.

3. What are the primary risks to FYCOMPA’s sales growth?

Patent expiration, increasing generic competition, reimbursement restrictions, and market saturation.

4. Are there ongoing trials for additional indications?

Yes, trials are underway for pediatric epilepsy and rare syndromes, which could expand the drug’s approved uses.

5. How does the market size of epilepsy treatments impact FYCOMPA?

A global epilepsy market exceeding $8 billion in 2022 offers significant growth potential, but competition for share is intense.

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References

[1] Eisai Inc. (2022). FYCOMPA (perampanel) Annual Report.
[2] World Health Organization. (2022). Epilepsy Fact Sheet.
[3] IQVIA. (2022). Global Epilepsy Treatment Market Analysis.
[4] FDA. (2018). Approval Letter for FYCOMPA.
[5] European Medicines Agency. (2021). Summary of Product Characteristics for FYCOMPA.