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Last Updated: April 21, 2024

FARYDAK Drug Patent 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 two patents protecting this drug.

This drug has sixty-seven patent family members in forty countries.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry 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 Loss of Exclusivity (LOE) 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
Abdullah KhanPhase 1
Secura BioPhase 1
Dana-Farber Cancer InstitutePhase 1

See all FARYDAK clinical trials

US Patents and Regulatory Information for FARYDAK

FARYDAK is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FARYDAK is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 FARYDAK

Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E- -2-propenamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of HDAC inhibitors for the treatment of myeloma
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE

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 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FARYDAK

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FARYDAK

When does loss-of-exclusivity occur for FARYDAK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1297
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 07257881
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0712993
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 50263
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 07001689
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1641328
Estimated Expiration: ⤷  Try a Trial

Patent: 2584673
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 440
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088976
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7984
Estimated Expiration: ⤷  Try a Trial

Patent: 0802383
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 86930
Estimated Expiration: ⤷  Try a Trial

Patent: 09967
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0115175
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0800280
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 08001862
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5015
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 09540006
Estimated Expiration: ⤷  Try a Trial

Patent: 13139476
Estimated Expiration: ⤷  Try a Trial

Patent: 15164968
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9337
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 08015900
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 529
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 511
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0800306
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 090135
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 080852
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 012501725
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 200900001
Estimated Expiration: ⤷  Try a Trial

Patent: 00900001
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0809094
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 090015968
Estimated Expiration: ⤷  Try a Trial

Patent: 140142335
Estimated Expiration: ⤷  Try a Trial

Patent: 150082690
Estimated Expiration: ⤷  Try a Trial

Patent: 160032264
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 53196
Estimated Expiration: ⤷  Try a Trial

Patent: 15179
Estimated Expiration: ⤷  Try a Trial

Patent: 0815344
Estimated Expiration: ⤷  Try a Trial

Patent: 1441190
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 08495
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 243
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 406
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering FARYDAK around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2420279 ПРИМЕНЕНИЕ ИНГИБИТОРОВ HDAC ДЛЯ ЛЕЧЕНИЯ МИЕЛОМЫ (APPLICATION OF HDAC INHIBITORS FOR TREATING MYELOMA) ⤷  Try a Trial
Malaysia 136892 DEACETYLASE INHIBITORS ⤷  Try a Trial
South Korea 20030031986 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FARYDAK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1318980 72/2015 Austria ⤷  Try a Trial PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901
1318980 15C0086 France ⤷  Try a Trial PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980 300778 Netherlands ⤷  Try a Trial PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.