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US Department of Justice
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Generated: November 21, 2018

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Panobinostat lactate - Generic Drug Details

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What are the generic sources for panobinostat lactate and what is the scope of panobinostat lactate freedom to operate?

Panobinostat lactate is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for panobinostat lactate. One supplier is listed for this compound.

Summary for panobinostat lactate
Pharmacology for panobinostat lactate
Synonyms for panobinostat lactate
(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 (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 panobinostat lactate

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 205353-003 Feb 23, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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
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 panobinostat lactate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90070-7 Sweden ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901
2015 00068 Denmark ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
2015000098 Germany ➤ Try a Free Trial PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Citi
QuintilesIMS
Daiichi Sankyo
Mallinckrodt
US Department of Justice
Express Scripts
Teva
Covington

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