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 one branded drug marketed by Catalyst Pharms and is included in two 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. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for PERAMPANEL

International Patents:	101
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	69
Patent Applications:	705
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PERAMPANEL

Constraining patent/regulatory exclusivity:

8,772,497

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

8,772,497

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PERAMPANEL

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

Sponsor	Phase
National Center for PTSD	Phase 2
Yale University	Phase 2
American Foundation for Suicide Prevention	Phase 2

See all PERAMPANEL clinical trials

Generic filers with tentative approvals for PERAMPANEL

Applicant	Application No.	Strength	Dosage Form
		8MG	TABLET;ORAL
		6MG	TABLET;ORAL
		4MG	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		RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-004	Oct 22, 2012		RX	Yes	No	6,949,571		Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-005	Oct 22, 2012		RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-006	Oct 22, 2012		RX	Yes	Yes	6,949,571		Y	Y
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277-001	Apr 29, 2016		RX	Yes	Yes	6,949,571		Y	Y

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/002434 Fycompa 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
European Patent Office	2177520
Israel	180151	METHOD FOR PRODUCING 1,2-DIHYDROPYRIDINE-2-ONE COMPOUND
Japan	5068069
Japan	WO2006004107	１，２−ジヒドロピリジン化合物の結晶およびその製造方法
Serbia	52752	KRISTAL JEDINJENJA 1,2-DIHIDROPIRIDINA I METOD ZA NJEGOVU PROIZVODNJU (CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND AND METHOD FOR PRODUCING SAME)

Supplementary Protection Certificates for PERAMPANEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1300396	300565	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
1300396	420	Finland
1300396	92113	Luxembourg		PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)
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	C300565	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723

Market Dynamics and Financial Trajectory for Perampanel

Introduction

Perampanel, marketed under the brand name Fycompa, is an anti-epileptic drug (AED) that has been making significant waves in the neurology sector. Here, we will delve into the market dynamics and financial trajectory of this drug, highlighting its current status, future projections, and the key factors influencing its market performance.

Market Size and Growth

The global perampanel market has been experiencing substantial growth. As of 2023, the epilepsy drugs market, which includes perampanel, was valued at USD 7.6 billion and is projected to reach USD 10.9 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.06% from 2024 to 2032[3].

Segmentation and Application

Perampanel is categorized based on its type (2mg, 4mg, 6mg, 10mg) and application (localized seizures, tonic-clonic seizures). The drug is widely used for treating various types of seizures, including partial-onset seizures and primary generalized tonic-clonic seizures[5].

Geographical Performance

North America currently leads the epilepsy drugs market, capturing a significant revenue share of 48% in 2023. However, the Asia Pacific region is expected to experience the highest CAGR of 6.8% during the forecast period, driven by supportive government initiatives and the introduction of new-generation antiepileptic drugs[3].

Recent Transactions and Market Impact

In December 2022, Eisai Co., Ltd. announced an agreement to transfer the U.S. commercial rights for Fycompa to Catalyst Pharmaceuticals, Inc. This transaction includes an exclusive negotiation period for an asset in Eisai’s epilepsy pipeline. Eisai will maintain its rights to Fycompa outside the U.S. and continue to manufacture and supply the drug globally. The deal is expected to maximize patient value in the U.S. due to Catalyst’s strong commitment to patients with epilepsy[1].

Financial Performance

Catalyst Pharmaceuticals reported strong financial results for the third quarter of 2023, with total net product revenues reaching $102.7 million, a 79.4% year-over-year increase. Specifically, Fycompa net product revenue was $36.4 million, marking a 5.2% increase compared to the second quarter of 2023. The company raised its 2023 full-year total revenue guidance to between $390 million and $395 million[2].

Revenue Streams and Milestones

Under the terms of the agreement with Eisai, Catalyst Pharmaceuticals will receive an up-front payment of $160 million upon closing the transaction. Additionally, Catalyst may receive milestone payments and royalties in the future. This financial structure is expected to bolster Catalyst’s revenue streams and support its continued focus on developing therapies for rare neuromuscular and neurological disorders[1].

Challenges and Restraints

Despite the positive outlook, the epilepsy drugs market, including perampanel, faces several challenges. One significant issue is the high cost of advanced treatments, which can limit accessibility, particularly in developing regions with constrained healthcare resources. Side effects associated with some antiepileptic drugs can also affect patient compliance and treatment outcomes, potentially slowing market growth[3].

Research and Development

Eisai remains committed to drug discovery and research for anti-epileptogenesis, focusing on the modulation of neuroinflammation or lipid metabolism in glia cells, as well as the application of new technologies like spatial RNA-sequence. This ongoing research aims to gain a deeper understanding of human brain biology and could lead to broader neuroscience discoveries[1].

Competitive Landscape

The epilepsy drugs market is competitive, with major players like UCB Pharma (Keppra, Vimpat) and Catalyst Pharmaceuticals. The market dynamics are influenced by the introduction of innovative drugs with fewer side effects and extended-release formulations, as well as personalized medicine tailored to genetic profiles[3].

Government Initiatives and Funding

Government initiatives and funding for epilepsy research continue to propel the development of new drugs. For instance, the Intersectoral Global Action Plan on Epilepsy and the Global Campaign Against Epilepsy have been instrumental in driving market growth in regions like the Asia Pacific[3].

Key Takeaways

• The global perampanel market is part of a larger epilepsy drugs market valued at USD 7.6 billion in 2023 and projected to reach USD 10.9 billion by 2032.
• North America leads the market, but the Asia Pacific region is expected to experience the highest CAGR.
• The transfer of U.S. commercial rights from Eisai to Catalyst Pharmaceuticals is expected to maximize patient value.
• Financial performance indicates strong revenue growth, with Catalyst Pharmaceuticals forecasting full-year revenues between $390 million and $395 million.
• Challenges include high treatment costs and side effects, but ongoing research and government initiatives are driving market growth.

FAQs

Q: What is the current market size of the epilepsy drugs market, and what is its projected growth? A: The epilepsy drugs market was valued at USD 7.6 billion in 2023 and is expected to reach USD 10.9 billion by 2032, growing at a CAGR of 4.06% from 2024 to 2032[3].

Q: Who are the major players in the epilepsy drugs market? A: Major players include UCB Pharma (Keppra, Vimpat) and Catalyst Pharmaceuticals (Fycompa, FIRDAPSE)[1][3].

Q: What are the key challenges facing the epilepsy drugs market? A: High costs of advanced treatments and side effects associated with some antiepileptic drugs are significant challenges[3].

Q: How has the recent transaction between Eisai and Catalyst Pharmaceuticals impacted the market? A: The transaction is expected to maximize patient value in the U.S. and support Catalyst’s focus on developing therapies for rare neuromuscular and neurological disorders[1].

Q: What role do government initiatives play in the epilepsy drugs market? A: Government initiatives and funding for epilepsy research are crucial in driving market growth and the development of new drugs[3].

Cited Sources:

1. Eisai Co., Ltd. - "EISAI TO DIVEST RIGHTS FOR ANTI-EPILEPTIC DRUG FYCOMPA® (Perampanel) CIII IN THE UNITED STATES TO CATALYST PHARMACEUTICALS, INC."
2. Catalyst Pharmaceuticals - "Catalyst Pharmaceuticals Reports Strong Third Quarter 2023 Financial Results"
3. SNS Insider - "Epilepsy Drugs Market Size, Share & Growth Report 2032"
4. Absolute Reports - "Global Perampanel Drug Market"
5. Market Research Intellect - "Global Perampanel Market Size, Scope And Forecast Report"