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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 patent protection?

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

Panobinostat lactate has one hundred and eleven patent family members in forty-seven countries.

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

Summary for panobinostat lactate

International Patents:	111
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	6
Patent Applications:	7
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

AKOS026676524

BCP25197

CHEBI:85991

CHEMBL3545368

D10019

EX-A2659

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)

SB16465

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
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		RX	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		RX	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		RX	Yes	Yes

International Patents for panobinostat lactate

Country	Patent Number	Estimated Expiration
Brazil	PI0712993
Slovenia	1912640
San Marino	P200900001

Supplementary Protection Certificates for panobinostat lactate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912640	PA2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	122015000098	Germany		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1912640	PA2016003	Lithuania		PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828