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 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 | 205353-003 | 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 | ⤷ 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 | 205353-001 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PANOBINOSTAT LACTATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Costa Rica | 10440 | POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-YL)ETIL]AMINO]METIL]FENIL]2E-2-PROPENAMIDA | ⤷ Try a Trial |
| Tunisia | SN08495 | POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2- METHYL-IH-INDOL-3-YL) ETHYL] MINO] METHYL] PHENYL] -2E-2-PROPENAMIDE | ⤷ Try a Trial |
| Japan | 2013173757 | USE OF HDAC INHIBITOR FOR TREATMENT OF MYELOMA | ⤷ 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 | 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 | 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 | C01318980/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
