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Generated: December 17, 2018

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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 Novartis Pharms Corp and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and ten patent family members in forty-six 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.

Summary for FARYDAK
Drug patent expirations by year for FARYDAK
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.

Synonyms for FARYDAK
(2E)-N-Hydroxy-3-(4-(((2-(2-methyl-1H-indol-3-yl)ethyl)amino(methyl)phenyl)prop-2-enamide mono((2RS)-2-hydroxypropanoate)
(E)-N-Hydroxy-3-(4-(((2-(2-methyl-1H-indol-3-yl)ethyl)amino)methyl)phenyl)acrylamide 2-hydroxypropanoate
2-hydroxypropanoic acid--(2E)-N-hydroxy-3-[4-({[2-(2-methyl-1H-indol-3-yl)ethyl]amino}methyl)phenyl]prop-2-enamide (1/1)
960055-56-5
AK481213
AKOS026676524
CHEBI:85991
CHEMBL3545368
D10019
Farydak (TN)
N-({4-[(1E)-3-(hydroxyamino)-3-oxoprop-1-en-1-yl]phenyl}methyl)-2-(2-methyl-1H-indol-3-yl)ethan-1-aminium 2-hydroxypropanoate
N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl) ethyl]amino]methyl]phenyl]-2E-2-propenamide DL-lactate salt
n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide dl-lactate salt
n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide lactate salt
Panobinostat lactate
Panobinostat lactate (JAN)
Panobinostat lactate [JAN]
Propanoic acid, 2-hydroxy-, compd. with (2E)-N-hydroxy-3-(4-(((2-(2-methyl-1H-indol-3-yl)ethyl)amino)methyl)phenyl)-2-propenamide (1:1)
Propanoic acid, 2-hydroxy-, compd. with (2E)-N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2-propenamide (1:1)
SCHEMBL2315056
SCHEMBL2315067
XVDWNSFFSMWXJJ-ASTDGNLGSA-N

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
Novartis Pharms Corp FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Novartis Pharms Corp FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for FARYDAK

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015 00068 Denmark ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901
0778 Netherlands ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901
90070-7 Sweden ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Citi
Accenture
Daiichi Sankyo
Boehringer Ingelheim
McKesson
Moodys
Julphar
QuintilesIMS

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 verifification 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.