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Last Updated: August 12, 2020

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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.

US ANDA Litigation and 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

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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
Dana-Farber Cancer InstitutePhase 1
CelgenePhase 1
Secura BioPhase 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   Start Trial   Start Trial   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>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 300778 Netherlands   Start Trial PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980 CA 2015 00068 Denmark   Start Trial PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980 CR 2015 00068 Denmark   Start Trial PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Moodys
Express Scripts
Boehringer Ingelheim
Colorcon
Merck

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.