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
*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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 205353-003 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-002 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-003 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >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 | ⤷ Sign Up |
| Tunisia | SN08495 | POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2- METHYL-IH-INDOL-3-YL) ETHYL] MINO] METHYL] PHENYL] -2E-2-PROPENAMIDE | ⤷ Sign Up |
| Mexico | 2008001610 | USO DE INHIBIDORES DE HDAC PARA EL TRATAMIENTO DE MIELOMA. (USE OF HDAC INHIBITORS FOR THE TREATMENT OF MYELOMA.) | ⤷ Sign Up |
| South Africa | 200809094 | Polymorphs of N-hydroxy-3-[4[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]pheny]-2E-2-propenamide | ⤷ Sign Up |
| Montenegro | 00529 | POLIMORFI N-HIDROKSI-3-[4-[[[2-(-METIL-1H-INDOL-3-IL)ETIL]AMINO]FENIL]-2E-2-PROPENAMIDA (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE) | ⤷ Sign Up |
| Morocco | 30511 | POLYMORPHES DE N-HYDROXY -3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2- PROPENAMIDE | ⤷ Sign Up |
| South Korea | 20160032264 | Ｎ-히드록시-3-〔4-〔〔〔2-(2-메틸-1Ｈ-인돌-3-일)에틸〕아미노〕메틸〕페닐〕-2Ｅ-2-프로펜아미드의 동질이상체 (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE) | ⤷ Sign Up |
| >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 | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901 |
| 1912640 | C20160001 00181 | Estonia | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAAT;REG NO/DATE: EU/1/15/1023 01.09.2015 |
| 1318980 | C 2015 053 | Romania | ⤷ Sign Up | 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 |
| 1912640 | PA2016003,C1912640 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828 |
| 1318980 | 1590070-7 | Sweden | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALTTHEREOF; REG. NO/DATE: EU/1/15/1023 20150901 |
| 1912640 | PA2016003 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTATAS; REGISTRATION NO/DATE: EU/1/15/1023 20120828 |
| 1318980 | C01318980/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
