FYCOMPA Drug Patent Profile

Which patents cover Fycompa, and when can generic versions of Fycompa launch?

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

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

The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the perampanel profile page.

DrugPatentWatch^® Generic Entry Outlook for Fycompa

Fycompa was eligible for patent challenges on October 22, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are four tentative approvals for the generic drug (perampanel), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for FYCOMPA

International Patents:	101
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	22
Patent Applications:	308
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

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

Constraining patent/regulatory exclusivity:

8,772,497

NDA:

208277

Dosage:

SUSPENSION;ORAL

Constraining patent/regulatory exclusivity:

8,772,497

NDA:

202834

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 FYCOMPA

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

Sponsor	Phase
Wayne State University	Phase 4
Eisai Korea Inc.	Phase 4
University of Florida	Phase 4

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 six US patents.

This potential generic entry date is based on patent 8,772,497.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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		RX	Yes	Yes	6,949,571		Y	Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-002	Oct 22, 2012		RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-003	Oct 22, 2012		RX	Yes	No	8,772,497			Y
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834-001	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	202834-001	Oct 22, 2012		RX	Yes	No	8,772,497			Y

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/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 FYCOMPA

See the table below for patents covering FYCOMPA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2404697
South Korea	100904011
Portugal	1300396
European Patent Office	1772450	PROCÉDÉ POUR LA FABRICATION D"UN COMPOSÉ DE 1,2-DIHYDROPYRIDINE-2-ONE (METHOD FOR PRODUCING 1,2-DIHYDROPYRIDINE-2-ONE COMPOUND)
Poland	1772450
New Zealand	550720	Crystal of 1,2-dihydropyridine compound and method for producing same

Supplementary Protection Certificates for FYCOMPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1300396	C01300396/01	Switzerland		PRODUCT NAME: PERAMPANEL; REGISTRATION NO/DATE: SWISSMEDIC 62440 14.12.2012
1300396	12C0074	France		PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
1300396	420	Finland
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	300565	Netherlands		PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT ERVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .....016 20120723
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

Market Dynamics and Financial Trajectory for FYCOMPA

Introduction

FYCOMPA (Perampanel) is a significant player in the antiepileptic drug market, particularly as the first and only non-competitive AMPA receptor antagonist approved for epilepsy. This article delves into the market dynamics and financial trajectory of FYCOMPA, especially following its acquisition by Catalyst Pharmaceuticals.

Market Context of Antiepileptic Drugs

The global antiepileptic drugs (AED) market is projected to grow from $17.13 billion in 2024 to $24.85 billion by 2032, at a CAGR of 4.8%[4].

• Geographical Segmentation: The market is dominated by North America, with Europe and Asia Pacific expected to exhibit higher growth rates due to increasing regulatory approvals and market penetration[4].
• Distribution Channels: Hospital pharmacies hold the dominant share, followed by retail and online pharmacies, which are also expected to grow significantly[4].

Acquisition by Catalyst Pharmaceuticals

Catalyst Pharmaceuticals acquired the U.S. commercial rights to FYCOMPA from Eisai Co., Ltd. in January 2023. This acquisition was a strategic move to expand Catalyst's commercial portfolio and strengthen its presence in neurology.

Strategic Rationale

• Complementary Growth Driver: FYCOMPA serves as a complementary growth driver, aligning with Catalyst's growth plans and expanding its reach into rare epileptic diseases[1][3].
• Revenue Diversification: The acquisition adds a successfully marketed product, diversifying Catalyst's revenue streams and enhancing its cash flow generation[1][3].
• Synergies with Existing Products: The physician call points for FYCOMPA overlap significantly with those for FIRDAPSE, another key product of Catalyst, facilitating synergistic sales efforts[1][3].

Financial Performance of FYCOMPA

Revenue Growth

• 2022 Fiscal Year: Eisai's U.S. FYCOMPA net revenues for the 2022 fiscal year were approximately $136 million[3].
• 2023 Financial Year: Following the acquisition, Catalyst reported FYCOMPA net product revenues of $138.1 million for the full year 2023, with $39.3 million in the fourth quarter alone[2][5].

Impact on Catalyst Pharmaceuticals' Financials

• Total Revenues: The acquisition significantly boosted Catalyst's total revenues, with a record $398.2 million in 2023, representing an 85.9% increase from 2022[2].
• EBITDA and EPS Accretion: The acquisition of FYCOMPA was expected to be accretive to EBITDA and EPS in 2023, which was realized with non-GAAP net income per share increasing by 90.9% and 92.2% on a basic and diluted basis, respectively[2][5].

Future Guidance

• 2024 Financial Guidance: Catalyst provided full-year 2024 total revenue guidance of between $455 million and $475 million, reflecting continued robust growth[2].

Market Presence and Competition

Dominant Players

• The global AED market is dominated by companies like UCB S.A., Pfizer, and GSK plc. However, Catalyst's acquisition of FYCOMPA positions it as a significant player in the neurology segment[4].

Competitive Advantage

• Unique Mechanism of Action: FYCOMPA's status as the first and only non-competitive AMPA receptor antagonist gives it a unique market position[1][3].
• Patent Protection: FYCOMPA has patent protection through at least 2027, providing a secure revenue stream for Catalyst[3].

Challenges and Opportunities

Adverse Reactions

• FYCOMPA is associated with adverse reactions such as hostility, aggression, and homicidal ideation, which can impact patient compliance and market perception[1].

Market Expansion

• The acquisition includes an exclusive option to evaluate and potentially add a rare epilepsy asset, further expanding Catalyst's reach into rare neurological and epileptic disorders[1][3].

Key Takeaways

• Strategic Acquisition: The acquisition of FYCOMPA by Catalyst Pharmaceuticals has been a strategic move to expand its commercial portfolio and strengthen its presence in neurology.
• Financial Growth: FYCOMPA has contributed significantly to Catalyst's revenue growth, with expected accretion to EBITDA and EPS.
• Market Position: FYCOMPA's unique mechanism of action and patent protection position it as a key player in the AED market.
• Future Prospects: The acquisition opens up opportunities for further expansion into rare epileptic diseases and synergistic growth with existing products.

FAQs

What is FYCOMPA, and how does it work?

FYCOMPA (Perampanel) is the first and only non-competitive AMPA receptor antagonist approved for epilepsy. It works by blocking the action of glutamate at AMPA receptors, which are involved in the transmission of excitatory signals in the brain.

Why did Catalyst Pharmaceuticals acquire FYCOMPA?

Catalyst acquired FYCOMPA to expand its commercial portfolio, diversify its revenue streams, and strengthen its presence in neurology. The acquisition aligns with Catalyst's growth plans and offers synergies with its existing product, FIRDAPSE.

What were the financial impacts of the FYCOMPA acquisition on Catalyst Pharmaceuticals?

The acquisition significantly boosted Catalyst's total revenues, with FYCOMPA contributing $138.1 million in net product revenues for the full year 2023. It was also accretive to EBITDA and EPS in 2023.

What are the potential challenges associated with FYCOMPA?

FYCOMPA is associated with adverse reactions such as hostility, aggression, and homicidal ideation, which can impact patient compliance and market perception.

What are the future prospects for FYCOMPA under Catalyst Pharmaceuticals?

The acquisition includes an exclusive option to evaluate and potentially add a rare epilepsy asset, further expanding Catalyst's reach into rare neurological and epileptic disorders. This positions FYCOMPA for continued growth and market expansion.

Sources

1. Catalyst Pharmaceuticals Completes the Acquisition of U.S. Rights to FYCOMPA® (Perampanel) CIII - Catalyst Pharmaceuticals.
2. Catalyst Pharmaceuticals Reports Strong Fourth Quarter and Full Year 2023 Financial Results - Catalyst Pharmaceuticals.
3. Catalyst Pharmaceuticals to Acquire U.S. Commercial Rights to FYCOMPA® (Perampanel) CIII From Eisai Co., Ltd - Catalyst Pharmaceuticals.
4. Antiepileptic Drugs [AED] Market Size, Trends | Forecast, 2032 - Fortune Business Insights.
5. Catalyst Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update - GlobeNewswire.