You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

~ Buy the FYCOMPA (perampanel) Drug Profile, 2024 PDF Report in the Report Store ~

FYCOMPA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Indicators of Generic Entry

< Available with Subscription >

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for FYCOMPA?
  • What are the global sales for FYCOMPA?
  • What is Average Wholesale Price for FYCOMPA?
Drug patent expirations by year for FYCOMPA
Drug Prices for FYCOMPA

See drug prices for FYCOMPA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FYCOMPA
Generic Entry Dates for FYCOMPA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION;ORAL
Generic Entry Dates for FYCOMPA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Wayne State UniversityPhase 4
Eisai Korea Inc.Phase 4
University of FloridaPhase 4

See all FYCOMPA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FYCOMPA is ⤷  Subscribe.

This potential generic entry date is based on patent ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-002 Oct 22, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-003 Oct 22, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-005 Oct 22, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Catalyst Pharms FYCOMPA perampanel TABLET;ORAL 202834-001 Oct 22, 2012 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for FYCOMPA

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

Country Patent Number Title Estimated Expiration
Denmark 1764361 ⤷  Subscribe
Spain 2404697 ⤷  Subscribe
Canada 2412172 COMPOSES 1,2-DIHYDROPYRIDINE, LEUR PROCEDE DE PREPARATION ET LEUR UTILISATION (1,2-DIHYDROPYRIDINE COMPOUNDS, MANUFACTURING METHOD THEREOF AND USE THEREOF) ⤷  Subscribe
Japan WO2006004100 1,2−ジヒドロピリジン−2−オン化合物の製造方法 ⤷  Subscribe
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) ⤷  Subscribe
Hong Kong 1104999 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FYCOMPA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1300396 12C0074 France ⤷  Subscribe PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723
1764361 173 5-2013 Slovakia ⤷  Subscribe 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 132012902109980 Italy ⤷  Subscribe PRODUCT NAME: PERAMPANEL(FYCOMPA); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/776/001 A EU/1/12/776/016, 20120723
1300396 SPC/GB12/057 United Kingdom ⤷  Subscribe PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723
1300396 C300566 Netherlands ⤷  Subscribe PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723
1300396 CA 2012 00052 Denmark ⤷  Subscribe
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

FYCOMPA Market Analysis and Financial Projection Experimental

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.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.