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Last Updated: June 14, 2021

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FARYDAK Drug Profile


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When do Farydak patents expire, and when can generic versions of Farydak launch?

Farydak is a drug marketed by Secura and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and thirteen patent family members in forty-eight countries.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the panobinostat lactate profile page.

DrugPatentWatch® Generic Entry Outlook for Farydak

Farydak was eligible for patent challenges on February 23, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 17, 2028. 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.

Indicators of Generic Entry

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Drug patent expirations by year for FARYDAK
Drug Prices for FARYDAK

See drug prices for FARYDAK

DrugPatentWatch® Estimated Generic Entry Opportunity Date for FARYDAK
Generic Entry Date for FARYDAK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 FARYDAK

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

SponsorPhase
Secura BioPhase 1
Dana-Farber Cancer InstitutePhase 1
CelgenePhase 1

See all FARYDAK clinical trials

US Patents and Regulatory Information for FARYDAK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for FARYDAK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1318980 2015/066 Ireland   Get Started Free PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1318980 92890 Luxembourg   Get Started Free PRODUCT NAME: PANOBINSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE , OU UN DERIVE DE CELUI-CI (FARYDAK); FIRST REGISTRATION: 20150901
1912640 C20160001 00181 Estonia   Get Started Free PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015
1318980 C 2015 053 Romania   Get Started Free PRODUCT NAME: PANOBINOSTAT SAU O SARE ACCEPTABILA FARMACEUTIC SAU UNDERIVAT AL ACESTUIAN-HIDROXI-3-[-[4-({[2-(2-METIL-1H-INDOL-3-IL)ETIL}AMINO}METIL)FENIL]]-2E-2-PROPENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF NATIONAL AUTHORISATION: 20150828; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF FIRST AUTHORISATION IN EEA: 20150828
1318980 CA 2015 00068 Denmark   Get Started Free PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980 72/2015 Austria   Get Started Free PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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