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Last Updated: August 17, 2022

TELOTRISTAT ETIPRATE - Generic Drug Details


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What are the generic drug 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: 45
Clinical Trials: 15
Patent Applications: 89
DailyMed Link:TELOTRISTAT ETIPRATE at DailyMed
Recent Clinical Trials for TELOTRISTAT ETIPRATE

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Barbara Ann Karmanos Cancer InstitutePhase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Uruguay 31364 FORMAS SOLIDAS DE (S)-2-AMINO-3-(4-2-AMINO-6-((R)1-(4-CLORO-2-(3-METIL-1H-PIRAZOL-1-IL)FENIL)-2,2,2-TRIFLUOROTOXI)-PIRIMIDIN-4-IL)FENIL)PROPANOATO DE ETILIO Y METODOS PARA SU USO. See Plans and Pricing
Colombia 6220855 COMPUESTO A BASE DE 54 -FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRIMIDINA Y METODOS PARA SU EMPLEO See Plans and Pricing
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) See Plans and Pricing
Argentina 068558 FORMAS SOLIDAS DE (S)-2-AMINO-3-(4-(-AMINO-6-((R)-1-(4-CLORO-2-(3-METIL-1H-PIRAZOL-1-IL)FENIL)-2,2,2-TRIFLUOROETOXI)PIRIMIDIN-4-IL)FENIL)PROPANOATO DE ETILO Y METODOS PARA SU USO See Plans and Pricing
Taiwan 200831102 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use See Plans and Pricing
Hungary E053098 See Plans and Pricing
China 101809018 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 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TELOTRISTAT ETIPRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 CR 2018 00011 Denmark See Plans and Pricing 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 C201830016 Spain See Plans and Pricing 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
2091940 CA 2018 00011 Denmark See Plans and Pricing 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 122018000025 Germany See Plans and Pricing PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940 C 2018 007 Romania See Plans and Pricing PRODUCT NAME: TELOTRISTAT SAU UN ESTER ACCEPTABIL FARMACEUTIC, SAU O SARE A ACESTUIA, IN PARTICULAR ETIL TELOTRISTAT, MAI PARTICULAR SARE HIPURAT DE ETIL TELOTRISTAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1224; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1224; DATE OF FIRST AUTHORISATION IN EEA: 20170918
2091940 2018C/009 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2091940 2018/011 Ireland See Plans and Pricing PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEROF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL.; REGISTRATION NO/DATE: EU/1/17/1224 20170918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Express Scripts
Mallinckrodt
McKesson
Merck

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