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Last Updated: June 28, 2022

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. 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
Abdullah KhanPhase 1
CelgenePhase 1
Secura Bio, Inc.Phase 1

See all FARYDAK clinical trials

US Patents and Regulatory Information for FARYDAK

FARYDAK is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FARYDAK is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of HDAC inhibitors for the treatment of myeloma
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE

FDA Regulatory Exclusivity protecting FARYDAK

TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 2 PRIOR REGIMENS, INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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: See Plans and Pricing

Australia

Patent: 07257881
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0712993
Estimated Expiration: See Plans and Pricing

Canada

Patent: 50263
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001689
Estimated Expiration: See Plans and Pricing

China

Patent: 1641328
Estimated Expiration: See Plans and Pricing

Patent: 2584673
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 440
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088976
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7984
Estimated Expiration: See Plans and Pricing

Patent: 0802383
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 86930
Estimated Expiration: See Plans and Pricing

Patent: 09967
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0115175
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0800280
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 08001862
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5015
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09540006
Estimated Expiration: See Plans and Pricing

Patent: 13139476
Estimated Expiration: See Plans and Pricing

Patent: 15164968
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9337
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08015900
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 529
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 511
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0800306
Estimated Expiration: See Plans and Pricing

Norway

Patent: 090135
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080852
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 012501725
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 200900001
Estimated Expiration: See Plans and Pricing

Patent: 00900001
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0809094
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 090015968
Estimated Expiration: See Plans and Pricing

Patent: 140142335
Estimated Expiration: See Plans and Pricing

Patent: 150082690
Estimated Expiration: See Plans and Pricing

Patent: 160032264
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 53196
Estimated Expiration: See Plans and Pricing

Patent: 15179
Estimated Expiration: See Plans and Pricing

Patent: 0815344
Estimated Expiration: See Plans and Pricing

Patent: 1441190
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08495
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 243
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 406
Estimated Expiration: See Plans and Pricing

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
Malaysia 136892 DEACETYLASE INHIBITORS See Plans and Pricing
Hungary 0300880 See Plans and Pricing
Poland 221738 See Plans and Pricing
Argentina 061297 POLIMORFOS DE N-HIDROXI -3- [4- [ [ [ 2- ( 2-METIL-1H-INDOL-3-IL) ETIL] AMINO] METIL] FENIL] -2E-2-PROPENAMIDA See Plans and Pricing
Cyprus 1116755 See Plans and Pricing
South Korea 20090015968 POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE See Plans and Pricing
Uruguay 30406 POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FARYDAK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1318980 122015000098 Germany See Plans and Pricing PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1318980 92890 Luxembourg See Plans and Pricing PRODUCT NAME: PANOBINSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE , OU UN DERIVE DE CELUI-CI (FARYDAK); FIRST REGISTRATION: 20150901
1318980 15C0086 France See Plans and Pricing PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1912640 PA2016003 Lithuania See Plans and Pricing PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980 1590070-7 Sweden See Plans and Pricing PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901
1912640 PA2016003,C1912640 Lithuania See Plans and Pricing PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980 2015/066 Ireland See Plans and Pricing PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828
>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.