Telotristat etiprate - Generic Drug Details

What are the generic sources for telotristat etiprate and what is the scope of freedom to operate?

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:	46
Clinical Trials:	15
Patent Applications:	101
DailyMed Link:	telotristat etiprate at DailyMed

Recent Clinical Trials for telotristat etiprate

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Barbara Ann Karmanos Cancer Institute	Phase 2
Ipsen	Phase 1

See all telotristat etiprate clinical trials

Pharmacology for telotristat etiprate

Drug Class	Tryptophan Hydroxylase Inhibitor
Mechanism of Action	Tryptophan Hydroxylase Inhibitors

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				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794-001	Feb 28, 2017		RX	Yes	Yes				Y

International Patents for telotristat etiprate

Country	Patent Number	Title	Estimated Expiration
Norway	345062
Japan	2010540551
South Korea	101464391
Eurasian Patent Organization	201070410	ТВЕРДЫЕ ФОРМЫ (S)-ЭТИЛ-2-АМИНО-3-(4-(2-АМИНО-6-((R)-1-(4-ХЛОР-2-(3-МЕТИЛ-1H-ПИРАЗОЛ-1-ИЛ)ФЕНИЛ)-2,2,2-ТРИФТОРЭТОКСИ)ПИРИМИДИН-4-ИЛ)ФЕНИЛ)ПРОПАНОАТА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Denmark	3176159
Chile	2008002880	(s)-2-amino-3-(4-(2-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 cristalino, sal hipurato y succionato del mismo; metodos de preparacion; forma de dosificacion farmaceutica; y uso para tratar sindrome carcinoide y trastorno gastrointestinal.
European Patent Office	2091940	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)

Supplementary Protection Certificates for telotristat etiprate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091940	C02091940/01	Switzerland		PRODUCT NAME: TELOTRISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66374 28.03.2018
2091940	2018/011	Ireland		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
2091940	CA 2018 00011	Denmark		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
2091940	11/2018	Austria		PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARER ESTER, ODER EIN SALZ DAVON, INSBESONDERE TELOTRISTATETHYL, INSBESONDERE DAS HIPPURATSALZ VON TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 (MITTEILUNG) 20170920
2091940	1890014-2	Sweden		PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULARLY TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
2091940	CR 2018 00011	Denmark		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