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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 fifty-six patent family members in twenty-six 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

International Patents:	56
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	33
Clinical Trials:	1
Patent Applications:	25
Drug Prices:	Drug price information for XERMELO
DailyMed Link:	XERMELO at DailyMed

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.

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 Hippurate

1137608-69-5

2-Benzamidoacetic acid, ((S)-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)-1-ethoxy-1-oxopr

2-benzamidoacetic acid, ((S)-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)-1-ethoxy-1-oxopropan-2-yl)amide salt

3T25U84H4U

4-[2-Amino-6-[(1R)-1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]-4-pyrimidi

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 N-benzoylglycine salt

4-[2-Amino-6-[(1R)-1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethoxy]-4-pyrimidinyl]-L-phenylalanineethylesterN-benzoylglycinesalt

AKOS027250730

AOB87109

BC660143

CHEMBL3348963

CS-0429

D09975

EX-A1619

FT-0697335

hippuric acid 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

HY-13055

LX 1606 Hippurate

LX-1606 Hippurate

LX1032 hippurate

LX1606 (Hippurate)

LX1606 Hippurate

MolPort-016-633-294

NCGC00346476-01

s2173

SC-94290

Telotristat ethyl hippurate

Telotristat etiprate

Telotristat etiprate (USAN)

Telotristat etiprate [USAN]

UNII-3T25U84H4U

W-5754

XSFPZBUIBYMVEA-CELUQASASA-N

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

International Patents for XERMELO

Country	Document Number	Estimated Expiration
Japan	5717445
Australia	2008304439
Taiwan	I439457
Mexico	2009006195

Supplementary Protection Certificates for XERMELO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0929	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