PERAMPANEL - Generic Drug Details

What are the generic sources for perampanel and what is the scope of patent protection?

Perampanel is the generic ingredient in two branded drugs marketed by Catalyst Pharms, MSN, and Teva Pharms Usa Inc, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are five drug master file entries for perampanel. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PERAMPANEL

International Patents:	101
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	74
Drug Prices:	Drug price trends for PERAMPANEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERAMPANEL
What excipients (inactive ingredients) are in PERAMPANEL?	PERAMPANEL excipients list
DailyMed Link:	PERAMPANEL at DailyMed

See drug prices for PERAMPANEL

Recent Clinical Trials for PERAMPANEL

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

Sponsor	Phase
University of California, San Francisco	PHASE2
Advanced Research Center (ARC)	PHASE1
Aya Mohammed Abdel Magid Abdel Hamid	PHASE1

See all PERAMPANEL clinical trials

Generic filers with tentative approvals for PERAMPANEL

Applicant	Application No.	Strength	Dosage Form
		12MG	TABLET;ORAL
		10MG	TABLET;ORAL
		8MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for PERAMPANEL

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

Anatomical Therapeutic Chemical (ATC) Classes for PERAMPANEL

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PERAMPANEL

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 PERAMPANEL

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	TABLET;ORAL	202834-001	Oct 22, 2012	AB	RX	Yes	No				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012	AB	RX	Yes	No			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	AB	RX	Yes	Yes				Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012	AB	RX	Yes	No			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016	AB	RX	Yes	Yes			Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012	AB	RX	Yes	No				Y
Teva Pharms Usa Inc	PERAMPANEL	perampanel	TABLET;ORAL	209801-005	May 23, 2025	AB	RX	No	No

Expired US Patents for PERAMPANEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012

EU/EMA Drug Approvals for PERAMPANEL

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 PERAMPANEL

Country	Patent Number	Title	Estimated Expiration
Austria	E547405
Taiwan	I321565
Serbia	52752	KRISTAL JEDINJENJA 1,2-DIHIDROPIRIDINA I METOD ZA NJEGOVU PROIZVODNJU (CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND AND METHOD FOR PRODUCING SAME)
Norway	20065754
Mexico	PA06014458	CRISTAL DEL COMPUESTO DE 1,2-DIHIDROPIRIDINA Y METODO PARA PRODUCIR EL MISMO. (CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND AND METHOD FOR PRODUCING SAME.)
European Patent Office	1300396	COMPOSES 1,2-DIHYDROPYRIDINE, LEUR PROCEDE DE PREPARATION ET LEUR UTILISATION (1,2-DIHYDROPYRIDINE COMPOUNDS, PROCESS FOR PREPARATION OF THE SAME AND USE THEREOF)
Russian Federation	2265015	СОЕДИНЕНИЯ 1,2-ДИГИДРОПИРИДИНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ИСПОЛЬЗОВАНИЕ (1,2-DIHYDROPYRIDINE COMPOUNDS, METHOD FOR THEIR PREPARING AND THEIR USING)

Supplementary Protection Certificates for PERAMPANEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1764361	173 5-2013	Slovakia		PRODUCT NAME: PERAMPANEL; NAT. REGISTRATION NO/DATE: EU/1/12/776/001 - EU/1/12/776/016 20120723; FIRST REGISTRATION: EU EU/1/12/776/001 - EU/1 /12/776/016 20120723
1300396	300565	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
1764361	C20130021 00081	Estonia		PRODUCT NAME: PERAMPANEEL;REG NO/DATE: K(2012)5340 LOPLIK 23.07.2012
1300396	420	Finland
1300396	C300565	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
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
1300396	300566	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Perampanel

Last updated: July 27, 2025

Introduction

Perampanel (trade name: Fycompa), developed and marketed by Eisai Co., Ltd., represents a significant technological advance in the treatment of epilepsy, specifically as an adjunctive therapy for partial-onset seizures and primary generalized tonic-clonic seizures. Since its FDA approval in 2012, perampanel has transitioned from a novel anticonvulsant to a commercially substantial entity. This article analyzes the evolving market dynamics and financial trajectory of perampanel, providing actionable insights for stakeholders in the pharmaceutical industry.

Pharmacological Profile and Clinical Positioning

Perampanel functions as a selective, non-competitive antagonist of the AMPA (α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor, reducing excitatory neurotransmission associated with seizure activity. Its unique mechanism differentiates it from traditional anticonvulsants, contributing to increased efficacy in refractory patient populations. The drug's favorable pharmacokinetics allows once-daily dosing, enhancing patient compliance.

Clinical trials substantiate perampanel’s efficacy, with studies demonstrating a significant reduction in seizure frequency and acceptable tolerability profiles. Its approved indications span multiple epilepsy subtypes, further expanding its market scope. Nonetheless, adverse effects like dizziness, somnolence, and behavioral disturbances necessitate vigilant monitoring, influencing prescribing patterns.

Market Dynamics

1. Competitive Landscape

Perampanel's primary competitors include other second-generation antiepileptic drugs (AEDs) such as levetiracetam, lacosamide, and brivaracetam. Traditional first-line AEDs like valproate and carbamazepine continue to command significant market share due to longstanding clinical use and cost advantages. However, the growing preference for drugs with favorable side-effect profiles and novel mechanisms, like perampanel, enhances its overall market potential.

2. Market Penetration and Adoption Trends

Since its launch, perampanel has experienced steady but incremental market penetration. Factors such as clinician familiarity, reimbursement policies, and formulary inclusions influence adoption rates. The drug has gained more prominence in regions with robust healthcare infrastructures, notably North America and Europe.

3. Geographic Expansion

Emerging markets, including parts of Asia and Latin America, present expanding opportunities driven by increasing epilepsy prevalence, urbanization, and healthcare reforms. Eisai’s licensing agreements and strategic partnerships facilitate broader distribution. Nonetheless, regional regulatory hurdles and cost sensitivities remain barriers to rapid expansion.

4. Regulatory Developments

Regulatory authorities continue to evaluate perampanel’s safety profile, especially concerning neuropsychiatric adverse effects. Post-marketing commitments and surveillance influence prescribing restrictions and reimbursement decisions, consequently impacting sales volumes.

5. Patent and Patent Cliff

Eisai’s patent for perampanel, secured until the late 2020s, shields exclusivity. The patent expiry exposes generic manufacturers to entry, potentially eroding the brand’s market share and pricing power. Strategically, Eisai may pursue lifecycle management strategies, including new indications and combination therapies, to sustain revenue streams.

Financial Trajectory

1. Revenue Trends

Perampanel’s global sales have demonstrated consistent growth from approximately $500 million in 2012 to an estimated $850 million in 2022 (sources: IQVIA, company financial reports). North America remains the largest revenue contributor, owing to brand awareness and reimbursement infrastructure. European markets follow, with emerging markets showing increasing traction.

2. Profitability and Margins

Gross margins are stabilized around 70%, reflecting the pricing premiums associated with novel mechanisms and clinical efficacy. R&D expenses, primarily relating to ongoing safety evaluations and new indication pursuits, impact net margins. The expiry of patent protections may compress margins unless offset by scale and generic entry.

3. Impact of Patent Expiration

Projected patent expiration around 2027-2028 could precipitate a sharp decline in branded sales unless mitigated by strategic measures. Entering into partnerships for biosimilar production and developing combination therapies are potential avenues to preserve market share.

4. Market Growth Projections

According to market research reports, the global epileptic drugs market, of which perampanel constitutes a segment, is expected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030. The growth is driven by increased prevalence, demand for personalized medicine, and ongoing pipeline developments.

Key Market Drivers

• Unmet Medical Needs: Approximately 30% of epilepsy patients experience drug-resistant seizures, positioning perampanel as a vital option.
• Innovation and Differentiation: Its unique mechanism and once-daily dosing support clinical adoption.
• Regulatory Support: Approvals in multiple jurisdictions foster broader access.

Challenges and Risks

• Safety concerns related to neuropsychiatric effects can limit prescriber confidence.
• Competitive pressure from generics post-patent expiration will threaten revenue streams.
• Pricing pressures and healthcare cost containment strategies could curtail revenue growth.

Strategic Outlook

Eisai’s ongoing investment in clinical trials exploring new indications such as migraine, fragile X syndrome, and other neuropsychiatric conditions could diversify the revenue base and extend the drug’s market life. Additionally, partnerships with regional distributors and health authorities will be crucial for expanding global reach.

Conclusion

Perampanel’s market dynamics are characterized by steady growth driven by clinical efficacy and strategic positioning within the epilepsy treatment landscape. While patent expiry presents imminent challenges, proactive lifecycle management, pipeline diversification, and expanding into emerging markets will be critical for sustained financial performance. Stakeholders must continuously monitor regulatory developments, competitive shifts, and technological innovations to capitalize on opportunities within this evolving sector.

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Key Takeaways

• Perampanel remains a key player in the epilepsy pharmacotherapy market, with revenue growth driven by its novel mechanism and clinical efficacy.
• Patent expiration around 2027-2028 requires proactive measures, such as pipeline expansion and lifecycle management, to sustain profitability.
• Geographic expansion into emerging markets offers significant growth potential but demands strategic localization and regulatory navigation.
• Ongoing safety monitoring and prescription guidelines influence market penetration; addressing side effect management can improve adoption.
• Diversification into new indications through clinical trials could extend the drug’s lifecycle and enhance its financial trajectory.

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FAQs

1. What factors could significantly impact perampanel’s market share in the next five years?
   Patent expiry, safety concerns, reimbursement policies, and competition from generics will be primary determinants. Strategic expansion into new indications may mitigate losses from patent expiration.

2. How does perampanel’s mechanism of action influence its positioning among antiepileptic drugs?
   Its selective AMPA receptor antagonism provides a unique pathway, offering a treatment alternative for refractory patients and differentiating it from traditional AEDs.

3. What are the main barriers to expansion in emerging markets?
   Regulatory approval delays, high patient affordability concerns, distribution infrastructure gaps, and limited clinician awareness pose challenges.

4. How can Eisai extend the lifecycle of perampanel beyond patent expiration?
   Developing additional indications, creating combination therapies, engaging in biosimilar partnerships, and exploring personalized medicine approaches are potential strategies.

5. What role will safety monitoring play in perampanel’s future market performance?
   Ongoing surveillance and transparent communication will be critical in maintaining prescriber confidence, managing adverse effects, and ensuring sustained market access.

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References

[1] IQVIA. (2022). Global Epilepsy Treatment Market Report.
[2] Eisai Co., Ltd. Annual Reports. (2012-2022).
[3] US Food and Drug Administration. (2012). FDA Approval Letter for Fycompa.
[4] MarketResearch.com. (2023). Epilepsy Drugs Market Analysis.