Panobinostat lactate - Generic Drug Details

What are the generic drug 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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Panobinostat lactate has sixty-seven patent family members in forty countries.

There is one drug master file entry for panobinostat lactate.

Summary for panobinostat lactate

International Patents:	67
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	1
Patent Applications:	58
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for panobinostat lactate
DailyMed Link:	panobinostat lactate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for panobinostat lactate

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.

Recent Clinical Trials for panobinostat lactate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Abdullah Khan	Phase 1

See all panobinostat lactate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for panobinostat lactate

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015		DISCN	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No			Y	Y
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015		DISCN	Yes	No
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015		DISCN	Yes	No

Expired US Patents for panobinostat lactate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-001	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-003	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015
Secura	FARYDAK	panobinostat lactate	CAPSULE;ORAL	205353-002	Feb 23, 2015

International Patents for panobinostat lactate

Country	Patent Number	Title	Estimated Expiration
Canada	2617274	UTILISATION D'INHIBITEURS HDAC POUR LE TRAITEMENT DU MYELOME (USE OF HDAC INHIBITORS FOR THE TREATMENT OF MYELOMA)
European Patent Office	1912640	UTILISATION D'INHIBITEUR HDAC PANOBINOSTAT POUR LE TRAITEMENT DU MYÉLOME (USE OF THE HDAC INHIBITOR PANOBINOSTAT FOR THE TREATMENT OF MYELOMA)
Mexico	2008001610	USO DE INHIBIDORES DE HDAC PARA EL TRATAMIENTO DE MIELOMA. (USE OF HDAC INHIBITORS FOR THE TREATMENT OF MYELOMA.)
Japan	2015164968	Ｎ−ヒドロキシ−３−［４−［［［２−（２−メチル−１Ｈ−インドール−３−イル）エチル］アミノ］メチル］フェニル］−２Ｅ−２−プロペンアミドの多形 (POLYMORPH OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOLE-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENE AMIDE)
Japan	2013139476	POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
South Korea	20080031937	USE OF HDAC INHIBITORS FOR THE TREATMENT OF MYELOMA
Chile	2007001689	FORMAS CRISTALINAS SUSTANCIALMENTE PURAS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA; COMPOSICION FARMACEUTICA, UTIL PARA TRATAR UNA ENFERMEDAD QUE RESPONDE A UNA INHIBICION DE LA ACTIVIDAD DE CINASA DE PROT

Supplementary Protection Certificates for panobinostat lactate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1318980	CR 2015 00068	Denmark		PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. 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
1912640	C20160001 00181	Estonia		PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015
1318980	SPC/GB15/085	United Kingdom		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/15/1023 20150901
1318980	2015/066	Ireland		PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828
1318980	300778	Netherlands		PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1912640	PA2016003	Lithuania		PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828