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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 freedom to operate?

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 thirteen patent family members in forty-eight countries.

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

Summary for panobinostat lactate

International Patents:	113
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Patent Applications:	7
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for panobinostat lactate
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

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	205353-003	Feb 23, 2015		RX	Yes	Yes			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		RX	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		RX	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	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	205353-001	Feb 23, 2015		RX	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		RX	Yes	Yes			Y	Y

International Patents for panobinostat lactate

Country	Patent Number	Estimated Expiration
Hungary	S1500068
South Korea	100585484
Japan	2009540006
Georgia, Republic of	P20115175
Denmark	1318980
Portugal	1318980
Ecuador	SP088976

Supplementary Protection Certificates for panobinostat lactate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	15C0086	France		PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980	1590070-7	Sweden		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901
1318980	CA 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901
1318980	122015000098	Germany		PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1912640	C20160001 00181	Estonia		PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015
1912640	PA2016003,C1912640	Lithuania		PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828
1318980	CR 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901