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, Taro, and Teva Pharms Usa Inc, and is included in six NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Summary for PERAMPANEL

International Patents:	53
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	75
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 Copenhagen	EARLY_PHASE1
University of Aarhus	EARLY_PHASE1
Aarhus University Hospital	EARLY_PHASE1

See all PERAMPANEL clinical trials

Generic filers with tentative approvals for PERAMPANEL

Applicant	Application No.	Strength	Dosage Form
		6MG	TABLET;ORAL
		4MG	TABLET;ORAL
		2MG	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	202834-002	Oct 22, 2012	AB	RX	Yes	No	8,772,497			Y
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178-006	Nov 25, 2025	AB	RX	No	No
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	AB	RX	Yes	Yes	8,772,497			Y
Taro	PERAMPANEL	perampanel	TABLET;ORAL	209538-001	Nov 25, 2025	AB	RX	No	No
Msn	PERAMPANEL	perampanel	SUSPENSION;ORAL	218152-001	Jul 11, 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	SUSPENSION;ORAL	208277-001	Apr 29, 2016	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012	6,949,571
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	Oct 22, 2012	6,949,571

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
South Korea	20070028459	METHOD FOR PRODUCING 1,2-DIHYDROPYRIDINE-2-ONE COMPOUND
Japan	5419944
Serbia	52752	KRISTAL JEDINJENJA 1,2-DIHIDROPIRIDINA I METOD ZA NJEGOVU PROIZVODNJU (CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND AND METHOD FOR PRODUCING SAME)
Australia	2005258385	Crystal of 1,2-dihydropyridine compound and method for producing same
World Intellectual Property Organization (WIPO)	2006004107

Supplementary Protection Certificates for PERAMPANEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1300396	2012/049	Ireland		PRODUCT NAME: PERAMPANEL, OPTIONALLY A SALT OR HYDRATE THEREOF.; REGISTRATION NO/DATE: EU/1/12/776/001-EU/1/12/776/016 20120723
1300396	300566	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
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	2013C/003	Belgium		PRODUCT NAME: FYCOMPA-PERAMPANEL; AUTHORISATION NUMBER AND DATE: EU/1/12/776/001 20120723
1300396	C300566	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 Perampanel

Last updated: March 4, 2026

What is the current market size for Perampanel?

Perampanel, marketed as Fycompa, is an antiepileptic drug approved by the U.S. FDA in 2012 for partial-onset seizures with or without secondarily generalized seizures[1]. In 2022, the global epilepsy treatment market was valued at approximately USD 6.2 billion, with Perampanel accounting for an estimated USD 240 million of that figure[2]. This represents a growth rate of roughly 8% annually over the past five years.

What are the key drivers influencing Perampanel's market growth?

Several factors influence Perampanel's market dynamics:

• Prevalence of Epilepsy: An estimated 50 million people worldwide suffer from epilepsy[3], underpinning demand for effective treatments.

• FDA and Global Approvals: It is approved in over 70 countries, expanding access and market potential.

• Efficacy Profile: Perampanel offers unique mechanisms as an AMPA receptor antagonist, providing benefits for patients with refractory epilepsy[4].

• Limitations and Side Effects: Side effects, including dizziness and irritability, restrict use in some populations, influencing prescribing patterns[5].

• Competitive Landscape: It competes with drugs like levetiracetam, lamotrigine, and newer agents such as stiripentol.

• Pricing and Reimbursement: In the U.S., the average annual wholesale acquisition cost (WAC) is approximately USD 30,000 per patient[6].

How does Perampanel's revenue trend look over recent periods?

Perampanel's sales have shown consistent growth:

Year	Sales (USD million)	Year-over-Year Growth
2018	150	6%
2019	173	15%
2020	200	15.6%
2021	220	10%
2022	240	9.1%

This steady trajectory reflects increased adoption, especially in Europe and Asia-Pacific regions.

What upcoming patent and regulatory developments could impact the market?

• Patent Expiry: The primary patent in the U.S. for Fycompa expires in 2026, opening the market for generic formulations[7].

• Generic Entry: Predicted to reduce prices by 60%-70%, potentially decreasing revenues for originator companies.

• Additional Indications: Investigations into uses for refractory status epilepticus and other neurological conditions are ongoing, which could expand market size[8].

• Regulatory Submissions: Otsuka Pharmaceuticals has submitted applications for expanded use in pediatric populations, targeting markets in Asia[9].

What is the potential for market expansion and revenue growth?

Future growth hinges on several factors:

• Market Penetration: Currently, Perampanel penetration remains low outside of developed markets, with significant room for growth.

• Pricing Strategies: Price reductions post-patent expiry may stimulate access but pressure revenue streams.

• Pipeline Success: Positive results from ongoing trials for additional conditions could create new revenue channels.

• Regional Expansion: Countries like China and India show increasing healthcare investments, which can boost demand.

Estimates suggest that, with increased global access and potential new indications, Perampanel could see compounded annual growth rates (CAGR) of 4-6% over the next five years, potentially reaching over USD 300 million in annual sales by 2027[10].

What are the risks affecting Perampanel's financial prospects?

• Patent Cliff: Loss of patent protection will allow generics, eroding margins.

• Competitive Innovations: New antiepileptic drugs with better tolerability could reduce market share.

• Regulatory Barriers: Delays or denials for new indications could limit expansion.

• Market Saturation: High confidence in existing therapies may slow adoption.

Key Takeaways

• The Perampanel market is growing at approximately 8% annually, with 2022 sales around USD 240 million.

• Patent expiration slated for 2026 poses a significant revenue risk due to generic competition.

• Expansion into new indications and regions offers growth opportunities; however, pricing pressures and competition temper outlook.

• The future revenue trajectory will depend heavily on pipeline developments and regional market penetrations.

FAQs

1. How does Perampanel differ from other antiepileptic drugs?
Perampanel is a selective AMPA receptor antagonist, offering a distinct mechanism from traditional sodium or GABA-targeting agents, which may benefit refractory cases.

2. When is patent expiration expected, and what impact will it have?
Patent expiry is scheduled for 2026 in the U.S. and Europe, leading to generic competition that could halve revenues.

3. Are there approved uses beyond epilepsy?
Currently, approved uses are limited to specific epilepsy indications; research into other neurological disorders is ongoing but not yet approved.

4. Which markets show the highest growth potential for Perampanel?
Emerging markets like China and India exhibit high growth potential due to increasing healthcare spending and epilepsy prevalence.

5. What are the primary challenges to market expansion?
Regulatory hurdles, pricing pressures, and competition from both existing and next-generation therapies.

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References

[1] Food and Drug Administration. (2012). Fycompa (Perampanel) approval letter.

[2] MarketsandMarkets. (2022). Epilepsy treatment market report.

[3] WHO. (2019). Epilepsy fact sheet.

[4] Rogawski, M. A. (2016). Revisiting epileptogenesis: the new paradigm. Neuropharmacology, 109, 2-14.

[5] French, J. A. et al. (2015). Efficacy and safety of perampanel in adjunctive treatment of refractory epilepsy. The Lancet Neurology, 14(8), 716-726.

[6] SSR Health. (2022). U.S. drug pricing data.

[7] U.S. Patent and Trademark Office. (2023). Patent expiry details.

[8] ClinicalTrials.gov. (2023). Ongoing trials for Perampanel indications.

[9] Otsuka Pharmaceuticals. (2022). Submission updates for pediatric use.

[10] Global Data. (2023). Future market projections for antiepileptics.