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 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
Generic Entry Date for panobinostat lactate*:
Constraining patent/regulatory exclusivity:
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 |
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 | 205353-001 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for panobinostat lactate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for panobinostat lactate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101354237 | ⤷ Try a Trial | |
Russian Federation | 2008107871 | ПРИМЕНЕНИЕ ИНГИБИТОРОВ HDAC ДЛЯ ЛЕЧЕНИЯ МИЕЛОМЫ | ⤷ Try a Trial |
Morocco | 30511 | POLYMORPHES DE N-HYDROXY -3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2- PROPENAMIDE | ⤷ Try a Trial |
Brazil | PI0614090 | uso de inibidores da hdac para o tratamento do mieloma | ⤷ Try a Trial |
Taiwan | 201441190 | Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2007019116 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2007146716 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for panobinostat lactate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1318980 | CA 2015 00068 | Denmark | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK SALT ELLER DERIVAT DERAF; REG. NO/DATE: EU/1/15/1023 20150901 |
1318980 | C01318980/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015 |
1318980 | SPC/GB15/085 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: UK EU/1/15/1023 20150901 |
1318980 | 1590070-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901 |
1318980 | 300778 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1023 20150901 |
1318980 | 72/2015 | Austria | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901 |
1318980 | CR 2015 00068 | Denmark | ⤷ Try a 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 |