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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

US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	6
Patent Applications:	6
DailyMed Link:	panobinostat lactate at DailyMed

Pharmacology for panobinostat lactate

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Histone Deacetylase Inhibitors Cytochrome P450 2D6 Inhibitors

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	205353-002	Feb 23, 2015		RX	Yes	No			Y	Y
Novartis Pharms Corp	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		RX	Yes	Yes			Y	Y
Novartis Pharms Corp	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		RX	Yes	No
Novartis Pharms Corp	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		RX	Yes	Yes

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International Patents for panobinostat lactate

Country	Document Number	Estimated Expiration
Japan	5665271
China	101641328
Netherlands	300778
San Marino	P200900001

Supplementary Protection Certificates for panobinostat lactate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016003	Lithuania		PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828
0778	Netherlands		PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901
2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
90070-7	Sweden		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901