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:	52
Clinical Trials:	15
Patent Applications:	76
DailyMed Link:	telotristat etiprate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for telotristat etiprate

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

See all telotristat etiprate clinical trials

Pharmacology for telotristat etiprate

Drug Class	Tryptophan Hydroxylase Inhibitor
Mechanism of Action	Tryptophan Hydroxylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for telotristat etiprate

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

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
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

International Patents for telotristat etiprate

Country	Patent Number	Title	Estimated Expiration
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)
South Africa	200903367	4-Phenyl-6-(2,2,2-trifluoro-1-phenylethoxy) pyrimidine-based compounds and methods of their use
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
New Zealand	577004	4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE
Portugal	3176159
Poland	3176159
Hungary	E027896

Supplementary Protection Certificates for telotristat etiprate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C02091940/01	Switzerland		PRODUCT NAME: TELOTRISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66374 28.03.2018
2091940	C 2018 007	Romania		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	713	Finland
2091940	C201830016	Spain		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	300929	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT