FARYDAK Drug Patent Profile
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When do Farydak patents expire, and what generic alternatives are available?
Farydak is a drug marketed by Secura and is included in one NDA. There are two patents protecting this drug.
This drug has sixty-seven patent family members in forty countries.
The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this compound. Additional details are available on the panobinostat lactate profile page.
DrugPatentWatch® Generic Entry Outlook for Farydak
Farydak was eligible for patent challenges on February 23, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 17, 2028. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for FARYDAK
International Patents: | 67 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 104 |
Clinical Trials: | 12 |
Patent Applications: | 1,202 |
Drug Prices: | Drug price information for FARYDAK |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FARYDAK |
What excipients (inactive ingredients) are in FARYDAK? | FARYDAK excipients list |
DailyMed Link: | FARYDAK at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FARYDAK
Generic Entry Date for FARYDAK*:
Constraining patent/regulatory exclusivity:
NDA:
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 FARYDAK
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Abdullah Khan | Phase 1 |
Secura Bio | Phase 1 |
Dana-Farber Cancer Institute | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for FARYDAK
US Patents and Regulatory Information for FARYDAK
FARYDAK is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FARYDAK is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting FARYDAK
Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E- -2-propenamide
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Use of HDAC inhibitors for the treatment of myeloma
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
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 | 205353-002 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Secura | FARYDAK | panobinostat lactate | CAPSULE;ORAL | 205353-001 | 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 | ⤷ 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 FARYDAK
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FARYDAK
When does loss-of-exclusivity occur for FARYDAK?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 1297
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 07257881
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0712993
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 50263
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 07001689
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1641328
Estimated Expiration: ⤷ Try a Trial
Patent: 2584673
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 440
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 088976
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 7984
Estimated Expiration: ⤷ Try a Trial
Patent: 0802383
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 86930
Estimated Expiration: ⤷ Try a Trial
Patent: 09967
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0115175
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0800280
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 08001862
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5015
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 09540006
Estimated Expiration: ⤷ Try a Trial
Patent: 13139476
Estimated Expiration: ⤷ Try a Trial
Patent: 15164968
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9337
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 08015900
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 529
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 511
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 0800306
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 090135
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 080852
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 012501725
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 200900001
Estimated Expiration: ⤷ Try a Trial
Patent: 00900001
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0809094
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090015968
Estimated Expiration: ⤷ Try a Trial
Patent: 140142335
Estimated Expiration: ⤷ Try a Trial
Patent: 150082690
Estimated Expiration: ⤷ Try a Trial
Patent: 160032264
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 53196
Estimated Expiration: ⤷ Try a Trial
Patent: 15179
Estimated Expiration: ⤷ Try a Trial
Patent: 0815344
Estimated Expiration: ⤷ Try a Trial
Patent: 1441190
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 08495
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 243
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 406
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering FARYDAK around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
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 |
Japan | 4012819 | ⤷ Try a Trial | |
Russian Federation | 2420279 | ПРИМЕНЕНИЕ ИНГИБИТОРОВ HDAC ДЛЯ ЛЕЧЕНИЯ МИЕЛОМЫ (APPLICATION OF HDAC INHIBITORS FOR TREATING MYELOMA) | ⤷ 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 FARYDAK
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1912640 | PA2016003,C1912640 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/1023 20120828 |
1318980 | C 2015 053 | Romania | ⤷ Try a 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 | 122015000098 | Germany | ⤷ Try a Trial | PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER DERIVAT HIERVON; REGISTRATION NO/DATE: EU/1/15/1023 20150828 |
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 |