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Last Updated: December 1, 2020

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Panobinostat lactate - Generic Drug Details

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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 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.

Pharmacology for panobinostat lactate

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   Start Trial   Start Trial Y Y   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-003 Feb 23, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-001 Feb 23, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Secura FARYDAK panobinostat lactate CAPSULE;ORAL 205353-002 Feb 23, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for panobinostat lactate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1318980 72/2015 Austria   Start Trial PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901
1318980 SPC/GB15/085 United Kingdom   Start Trial PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/15/1023 20150901
1318980 C 2015 053 Romania   Start Trial PRODUCT NAME: PANOBINOSTAT SAU O SARE ACCEPTABILA FARMACEUTIC SAU UNDERIVAT AL ACESTUIAN-HIDROXI-3-[-[4-({[2-(2-METIL-1H-INDOL-3-IL)ETIL}AMINO}METIL)FENIL]]-2E-2-PROPENAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF NATIONAL AUTHORISATION: 20150828; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1023/001, EU/1/15/1023/002, EU/1/15/1023/003, EU/1/15/1023/004, EU/1/15/1023/005, EU/1/15/1023/006, EU/1/15/1023/007, EU/1/15/1023/008, EU/1/15/1023/009; DATE OF FIRST AUTHORISATION IN EEA: 20150828
1318980 15C0086 France   Start Trial PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901
1318980 CR 2015 00068 Denmark   Start Trial PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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