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Last Updated: February 22, 2020

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XERMELO Drug Profile


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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

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Summary for XERMELO
Drug patent expirations by year for XERMELO
Drug Prices for XERMELO

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Generic Entry Opportunity Date for XERMELO
Generic Entry Date for XERMELO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
IpsenPhase 3
European Organisation for Research and Treatment of Cancer - EORTCPhase 3
Emory UniversityPhase 2

See all XERMELO clinical trials

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

Supplementary Protection Certificates for XERMELO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 2018C/009 Belgium   Start Trial 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   Start 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 18C1009 France   Start 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   Start 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
2091940 11/2018 Austria   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.