DrugPatentWatch Database Preview

XERMELO Drug Profile

Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

When do Xermelo patents expire, and when can generic versions of Xermelo launch?

Xermelo is a drug marketed by Lexicon Pharms Inc and is included in one NDA. There are five patents protecting this drug.

This drug has sixty-two patent family members in twenty-nine countries.

The generic ingredient in XERMELO is telotristat etiprate. One supplier is listed for this compound. Additional details are available on the telotristat etiprate profile page.

US ANDA Litigation and Generic Entry Outlook for Xermelo

Xermelo will be eligible for patent challenges on February 28, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 27, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XERMELO

International Patents:	62
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	36
Clinical Trials:	3
Patent Applications:	28
Drug Prices:	Drug price information for XERMELO
DailyMed Link:	XERMELO at DailyMed

See drug prices for XERMELO

Generic Entry Opportunity Date for XERMELO

NDA:

208794

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 XERMELO

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

Sponsor	Phase
Ipsen	Phase 3
European Organisation for Research and Treatment of Cancer - EORTC	Phase 3
Emory University	Phase 2

See all XERMELO clinical trials

Pharmacology for XERMELO

Drug Class	Tryptophan Hydroxylase Inhibitor
Mechanism of Action	Tryptophan Hydroxylase Inhibitors

Synonyms for XERMELO

(S)-Ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate

1033805-22-9

3791AH

8G388563M7

ABP000310

AKOS030230308

AS-35061

BCP9000866

C27H26ClF3N6O3

CHEMBL2105695

CS-2311

D09974

ethyl (2S)-2-amino-3-[4-[2-amino-6-[(1R)-1-[4-chloro-2-(3-methylpyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]pyrimidin-4-yl]phenyl]propanoate

EX-A322

FT-0771085

GTPL9490

HY-13055A

J-524318

KB-78222

KS-0000067M

LX 1032

LX 1606

LX-1606

LX1606

LX1606 /LX-1606

MDSQOJYHHZBZKA-GBXCKJPGSA-N

MolPort-028-720-356

NCGC00390241-01

RL00164

SB18006

SCHEMBL610588

TELOTRISTAT ETHYL

Telotristat ethyl (USAN)

Telotristat ethyl [USAN]

Telotristat ethyl; (2S)-2-Amino-3-[4-[2-amino-6-[[(1R)-1-[4-chloro-2-(3-methylpyrazol-1-yl)phenyl]-2,2,2-trifluoroethyl]oxy]pyrimidin-4-yl]phenyl]propionic acid ethyl ester

Telotristat ethyl|||4-[2-amino-6-[(1R)-1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]-4-pyrimidinyl]-L-phenylalanine, ethyl ester

UNII-8G388563M7

Xermelo (TN)

ZINC43205655

US Patents and Regulatory Information for XERMELO

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

International Patents for XERMELO

Country	Patent Number	Estimated Expiration
Netherlands	300929
Brazil	PI0720270
Peru	20090742
Israel	204373
Hong Kong	1145023
Poland	2091940

Supplementary Protection Certificates for XERMELO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2091940	2018C/009	Belgium		PRODUCT NAME: TELOTRISTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER OF ZOUT, IN HET BIJZONDER TELOTRISTAT ETHYL, MEER IN HET BIJZONDER HET HIPPURAAT ZOUT VAN TELOTRISTAT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/17/1224 20170920
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	18C1009	France		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		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	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	300929	Netherlands		PRODUCT NAME: TELOTRISTAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ESTER OF ZOUT, IN HET BIJZONDER TELOTRISTAT ETHYL, MEER IN HET BIJZONDER HET HIPPURAAT ZOUT VAN TELOTRISTAT ETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170920