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Generated: May 24, 2019

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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 patent family members in twenty-eight 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.

Summary for XERMELO
Drug patent expirations by year for XERMELO
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.

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

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Supplementary Protection Certificates for XERMELO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 C201830016 Spain ➤ Sign Up 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 ➤ Sign Up 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 ➤ Sign Up 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
2091940 2018C/009 Belgium ➤ Sign Up 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 122018000025 Germany ➤ Sign Up PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940 1890014-2 Sweden ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Fish and Richardson
Fuji
Cipla
McKinsey

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