PERAMPANEL Drug Patent Profile

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

Perampanel is a drug marketed by MSN, Taro, and Teva Pharms Usa Inc. and is included in four NDAs.

The generic ingredient in PERAMPANEL 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 Perampanel

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

Summary for PERAMPANEL

US Patents:	0
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	75
Drug Prices:	Drug price information for PERAMPANEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERAMPANEL
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

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
Msn	PERAMPANEL	perampanel	SUSPENSION;ORAL	218152-001	Jul 11, 2025	AB	RX	No	No
Teva Pharms Usa Inc	PERAMPANEL	perampanel	TABLET;ORAL	209801-005	May 23, 2025	AB	RX	No	No
Msn	PERAMPANEL	perampanel	TABLET;ORAL	218178-006	Nov 25, 2025	AB	RX	No	No

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

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.