FARYDAK Drug Patent Profile
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When do Farydak patents expire, and when can generic versions of Farydak launch?
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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for FARYDAK?
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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
*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 |
| Dana-Farber Cancer Institute | Phase 1 |
| Celgene | Phase 1 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of HDAC inhibitors for the treatment of myeloma
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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 | 205353-001 | 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 | 205353-003 | Feb 23, 2015 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ 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 FARYDAK
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 205353-001 | Feb 23, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| 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 |
| >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
Patent: POLIMORFOS DE N-HIDROXI -3- [4- [ [ [ 2- ( 2-METIL-1H-INDOL-3-IL) ETIL] AMINO] METIL] FENIL] -2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07257881
Patent: Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0712993
Patent: polimorfos de n-hidróxi-3-[4[[[2-(2-metil-1h-indol-3-il) etil]amino]metil]fenil]-2e-2-propenamida
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 50263
Patent: POLYMORPHES DE N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 07001689
Patent: FORMAS CRISTALINAS SUSTANCIALMENTE PURAS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA; COMPOSICION FARMACEUTICA, UTIL PARA TRATAR UNA ENFERMEDAD QUE RESPONDE A UNA INHIBICION DE LA ACTIVIDAD DE CINASA DE PROT
Estimated Expiration: ⤷ Sign Up
China
Patent: 1641328
Patent: Polymorphs of n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide
Estimated Expiration: ⤷ Sign Up
Patent: 2584673
Patent: Polymorphs of n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 440
Patent: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-YL)ETIL]AMINO]METIL]FENIL]2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 088976
Patent: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7984
Patent: КРИСТАЛЛИЧЕСКИЕ БЕЗВОДНЫЕ ФОРМЫ ЛАКТАТА N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-АКРИЛАМИДА (CRYSTALLINE WATER-FREE FORMS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE LACTATE)
Estimated Expiration: ⤷ Sign Up
Patent: 0802383
Patent: ПОЛИМОРФНЫЕ ФОРМЫ N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-АКРИЛАМИДА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 86930
Patent: POLYMORPHES DE N-HYDROXY-3-[4-[[[2-(2-MÉTHYL-1H-INDOL-3-YL)ÉTHYL]AMINO]MÉTHYL]PHÉNYL]-2E-2-PROPÉNAMIDE (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE)
Estimated Expiration: ⤷ Sign Up
Patent: 09967
Patent: POLYMORPHES DE N-HYDROXY-3-[4-[[[2-(2-MÉTHYL-1H-INDOL-3-YL)ÉTHYL]AMINO]MÉTHYL]PHÉNYL]-2E-2-PROPÉNAMIDE (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE)
Estimated Expiration: ⤷ Sign Up
Georgia, Republic of
Patent: 0115175
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3- YL)ETHYL] AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 0800280
Patent: POLIMORFO DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Honduras
Patent: 08001862
Patent: POLIMORFOS DE N-HODROXI-3 [4-[[[2-METIL-1H-INDOL-3-IL)ETIL]AMINO] METIL]FENIL]-2E-2-2PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5015
Patent: צורה גבישית חסרת מים של מלח לקטט של n-הידרוקסי-3-[4-[[[2-(2-מתיל-h1-אינדול-3-יל)אתיל]אמינו]מתיל]פניל]-e2-2-פרופנאמיד (Substantially pure crystalline anhydrous form of the lactate salt of n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 09540006
Estimated Expiration: ⤷ Sign Up
Patent: 13139476
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Patent: 15164968
Patent: Ｎ−ヒドロキシ−３−［４−［［［２−（２−メチル−１Ｈ−インドール−３−イル）エチル］アミノ］メチル］フェニル］−２Ｅ−２−プロペンアミドの多形 (POLYMORPH OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOLE-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENE AMIDE)
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9337
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 08015900
Patent: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMIN O]METIL]FENIL]-2E-2-PROPENAMIDA. (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]A MINO]METHYL]PHENYL]-2E-2-PROPENAMIDE.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 529
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 511
Patent: POLYMORPHES DE N-HYDROXY -3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2- PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 0800306
Patent: POLIMORFOS DE N-HIDROXI - 3 - [4 - [[[2 - (2-METIL - 1H - INDOL - 3 - IL) ETIL] AMINO] METIL] FENIL] - 2E - 2 - PROPENAMIDA.
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 090135
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 080852
Patent: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL)ETIL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 012501725
Patent: POLYMORPHS OF N-HYDROXY3-[4[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
San Marino
Patent: 200900001
Patent: Polimorfi di n-idrossi-3[4-[[[2-(2-metil-1h-indol-3-il)etil]ammino]metil]fenil]-2e-2-propenammide
Estimated Expiration: ⤷ Sign Up
Patent: 00900001
Patent: Polimorfi di n-idrossi-3[4-[[[2-metil-1h-indol-3-il)etil]ammino]metil]fenil]-2e-2-propenammide
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0809094
Patent: Polymorphs of N-hydroxy-3-[4[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]pheny]-2E-2-propenamide
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090015968
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Patent: 140142335
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Patent: 150082690
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 160032264
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 53196
Estimated Expiration: ⤷ Sign Up
Patent: 15179
Estimated Expiration: ⤷ Sign Up
Patent: 0815344
Patent: Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide
Estimated Expiration: ⤷ Sign Up
Patent: 1441190
Patent: Polymorphs of N-hydroxy-3-[4-[[[2-(2-methyl-1H-indol-3-yl)ethyl]amino]methyl]phenyl]-2E-2-propenamide
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 08495
Patent: POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2- METHYL-IH-INDOL-3-YL) ETHYL] MINO] METHYL] PHENYL] -2E-2-PROPENAMIDE
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 243
Patent: КРИСТАЛІЧНА БЕЗВОДНА ФОРМА (ФОРМА А) N-ГІДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H-ІНДОЛ-3-ІЛ)ЕТИЛ]АМІНО]МЕТИЛ]ФЕНІЛ]-2E-2-ПРОПЕНАМІДУ[КРИСТАЛЛИЧЕСКАЯ БЕЗВОДНАЯ ФОРМА (ФОРМА А) N-ГИДРОКСИ-3-[4-[[[2-(2-МЕТИЛ-1H- ИНДОЛ-3-ИЛ)ЭТИЛ]АМИНО]МЕТИЛ]ФЕНИЛ]-2E-2-ПРОПЕНАМИДА (CRYSTALLINE ANHYDROUS FORM OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 406
Patent: POLIMORFOS DE N-HIDROXI-3-[4-[[[2-(2-METIL-1H-INDOL-3-IL]AMINO]METIL]FENIL]-2E-2-PROPENAMIDA
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Nicaragua | 200800306 | POLIMORFOS DE N-HIDROXI - 3 - [4 - [[[2 - (2-METIL - 1H - INDOL - 3 - IL) ETIL] AMINO] METIL] FENIL] - 2E - 2 - PROPENAMIDA. | ⤷ Sign Up |
| Ecuador | SP034492 | DERIVADOS DE HIDROXAMATO UTILES COMO INHIBIDORES DE DESACETILASA | ⤷ Sign Up |
| San Marino | P200900001 | Polimorfi di n-idrossi-3[4-[[[2-metil-1h-indol-3-il)etil]ammino]metil]fenil]-2e-2-propenammide | ⤷ Sign Up |
| Japan | 4012819 | ⤷ Sign Up | |
| European Patent Office | 1870399 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FARYDAK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1318980 | CR 2015 00068 | Denmark | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER PANOBINOSTATLAKTAT; REG. NO/DATE: EU/1/15/1023 20150901 |
| 1318980 | 15C0086 | France | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/1023 20150901 |
| 1318980 | 2015/066 | Ireland | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1023 20150828 |
| 1318980 | C01318980/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT; REGISTRATION NO/DATE: SWISSMEDIC 61878 23.12.2015 |
| 1318980 | 72/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: PANOBINOSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1023 (MITTEILUNG) 20150901 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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