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Fycompa is a drug marketed by Eisai Inc and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
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. One supplier is listed for this compound. Additional details are available on the perampanel profile page.
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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
There are two tentative approvals for the generic drug (perampanel), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Generic Entry Opportunity 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
|National Cancer Institute (NCI)||Phase 4|
|Mayo Clinic||Phase 4|
|Kimford Jay Meador||Phase 4|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Eisai Inc||FYCOMPA||perampanel||SUSPENSION;ORAL||208277-001||Apr 29, 2016||RX||Yes||Yes||Start Trial||Start Trial||Y||Y||Start Trial|
|Eisai Inc||FYCOMPA||perampanel||TABLET;ORAL||202834-002||Oct 22, 2012||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|Eisai Inc||FYCOMPA||perampanel||TABLET;ORAL||202834-003||Oct 22, 2012||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1764361||173 5-2013||Slovakia||Start Trial||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||92113||Luxembourg||Start Trial||PRODUCT NAME: PERAMPANEL ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (FYCOMPA)|
|1300396||C300566||Netherlands||Start Trial||PRODUCT NAME: PERAMPANEL, EEN ZOUT OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/12/776/001 .... 016 20120723|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|