FYCOMPA Drug Patent Profile
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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
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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: | 306 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FYCOMPA
*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 |
Pharmacology for FYCOMPA
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting FYCOMPA
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY 4 YEARS OF AGE AND OLDER
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARTIAL-ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES IN PATIENTS WITH EPILEPSY
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF EPILEPSY
1,2-dihydropyridine compounds, process for preparation of the same and use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES AS ADJUNCTIVE THERAPY IN PATIENTS WITH EPILEPSY 12 YEARS OF AGE AND OLDER
Method for producing 1, 2-dihydropyridine-2-one compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-002 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-003 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-001 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-005 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 |
|---|---|---|---|
| China | 104402807 | METHOD FOR PRODUCING CRYSTAL OF 1,2-DIHYDROPYRIDINE COMPOUND | ⤷ Sign Up |
| Hungary | 229553 | 1,2-DIHYDROPYRIDINE COMPOUND, PROCESS FOR PREPARATION OF THE SAME AND USE THEREOF | ⤷ Sign Up |
| Hungary | 0303398 | ⤷ Sign Up | |
| Australia | 2001262723 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0196308 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FYCOMPA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1300396 | C300566 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723 |
| 1300396 | CA 2012 00052 | Denmark | ⤷ Sign Up | |
| 1300396 | SPC/GB12/057 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PERAMPANEL, OPTIONALLY IN THE FORM OF A SALT OR HYDRATE; REGISTERED: UK EU/1/12/776/001- 016 20120723 |
| 1300396 | 12C0074 | France | ⤷ Sign Up | PRODUCT NAME: PERAMPANEL, SEL DE CELUI-CI OU HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/12/776/001 20120723 |
| 1300396 | 92113 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA) |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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.
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