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
Sponsor | Phase |
---|---|
Barbara Ann Karmanos Cancer Institute | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Ipsen | Phase 1 |
Pharmacology for telotristat etiprate
Drug Class | Tryptophan Hydroxylase Inhibitor |
Mechanism of Action | Tryptophan Hydroxylase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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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