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Last Updated: March 29, 2024

Telotristat etiprate - Generic Drug Details


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What are the generic sources for telotristat etiprate and what is the scope of patent protection?

Telotristat etiprate is the generic ingredient in one branded drug marketed by Tersera and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Telotristat etiprate has seventy patent family members in twenty-nine countries.

Two suppliers are listed for this compound.

Summary for telotristat etiprate
International Patents:70
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 15
Patent Applications: 76
DailyMed Link:telotristat etiprate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for telotristat etiprate
Generic Entry Date for telotristat etiprate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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 telotristat etiprate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Barbara Ann Karmanos Cancer InstitutePhase 2
National Cancer Institute (NCI)Phase 2
IpsenPhase 1

See all telotristat etiprate clinical trials

Pharmacology for telotristat etiprate

US Patents and Regulatory Information for telotristat etiprate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  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

International Patents for telotristat etiprate

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 200970575 СОЕДИНЕНИЯ НА ОСНОВЕ 4-ФЕНИЛ-6-(2,2,2-ТРИФТОР-1-ФЕНИЛЭТОКСИ)ПИРИМИДИНА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ ⤷  Try a Trial
Japan 2010512416 ⤷  Try a Trial
European Patent Office 2203444 FORMES SOLIDES DE PROPANOATE DE (S)-ÉTHYL-2-AMINO-3-(4-(2-AMINO-6-((R)-1-(4-CHLORO-2-O-MÉTHYL-1H-PYRAZOL-1-YL)PHÉNYL)-2,2,2-TRIFLUOROÉTHOXY)-PYRIMIDIN-4-YL)PHÉNYLE) (SOLIDS FORMS OF ( S) -ETHYL 2-AMIN0-3- (4- (2 -AMINO- 6- ( (R) -1- (4-CHL0R0-2- O-METHYL-IH-PYRAZOL- 1-YL) PHENYL) -2, 2, 2-TRIFLUORETHOXY) -PYRIMIDIN-4-YL) PHENYL) PROPANOATE) ⤷  Try a Trial
European Patent Office 2589600 Composés 4-phényle-6-(2,2,2-trifluoro-1-phényléthoxy) à base de pyrimidine et procédés concernant leur utilisation (4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use) ⤷  Try a Trial
Ecuador SP10010076 Formas Sólidas de (S)-etil-2-amino-3-(4 - (2-amino-6-((R) -1 - (4-cloro-2-(3-metil-1H-pirazol-1-YL ) fenil) -2,2,2-trifluoroetoxi)-pirimidina-4-il) fenil) propanoato y Métodos de su Uso ⤷  Try a Trial
Spain 2856871 ⤷  Try a Trial
Ukraine 99270 СПОЛУКИ НА ОСНОВІ 4-ФЕНІЛ-6-(2,2,2-ТРИФТОР-1-ФЕНІЛЕТОКСИ)ПІРИМІДИНУ І ЇХ ЗАСТОСУВАННЯ[СОЕДИНЕНИЯ НА ОСНОВЕ 4-ФЕНИЛ-6-(2,2,2-ТРИФТОР-1-ФЕНИЛЕТОКСИ)ПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for telotristat etiprate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 SPC/GB18/009 United Kingdom ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REGISTERED: UK EU/1/17/1224/001-002 20170920; UK PLGB 28247/0008 20170920
2091940 132018000000181 Italy ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT O UN SUO ESTERE FARMACEUTICAMENTE ACCETTABILE, O UN SUO SALE, IN PARTICOLARE TELOTRISTAT ETILE, PIU IN PARTICOLARE SALE IPPURATO DI TELOTRISAT ETILE(XERMELO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1224, 20170920
2091940 CR 2018 00011 Denmark ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT OR A C1-4 ALKYL ESTER THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
2091940 CA 2018 00011 Denmark ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, INPARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
2091940 713 Finland ⤷  Try a Trial
2091940 18C1009 France ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT OU L'UN DE SES ESTERS PHARMACEUTIQUEMENT ACCEPTABLES, OU L'UN DE LEURS SELS, EN PARTICULIER LE TELOTRISTAT D'ETHYLE ET PLUS PARTICULIEREMENT L'HIPPURATE DE TELOTRISTAT D'ETHYLE; REGISTRATION NO/DATE: EU/1/17/1224 20170920
2091940 C201830016 Spain ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT, O ESTER FARMACEUTICAMENTE ACEPTABLE, O UNA SALA DEL MISMO, EN PARTICULAR TELOTRISTAT DE ESTILO, MAS PARTICULARMENTE LA SAL HIPURATO DE TELOTRISTAT DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/17/1224; DATE OF AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1224; DATE OF FIRST AUTHORISATION IN EEA: 20170918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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