PERAMPANEL - Generic Drug Details
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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 three 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
Generic Entry Dates for PERAMPANEL*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
Generic Entry Dates for PERAMPANEL*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
VA Connecticut Healthcare System | Phase 2 |
National Center for PTSD | Phase 2 |
Yale University | Phase 2 |
Generic filers with tentative approvals for PERAMPANEL
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 12MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 8MG | 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
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 | 202834-004 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Catalyst Pharms | FYCOMPA | perampanel | SUSPENSION;ORAL | 208277-001 | Apr 29, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Catalyst Pharms | FYCOMPA | perampanel | TABLET;ORAL | 202834-006 | Oct 22, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 | 202834-001 | Oct 22, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PERAMPANEL
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 | |
Brazil | PI0510254 | cristal de composto de 1,2-diidropiridina e método para produzir o mesmo | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PERAMPANEL
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) |
1764361 | C 2013 025 | Romania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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