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Last Updated: July 6, 2020

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XERMELO Drug Profile


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Which patents cover Xermelo, 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
European Organisation for Research and Treatment of Cancer - EORTCPhase 3
Emory UniversityPhase 2
IpsenPhase 3

See all XERMELO clinical trials

Pharmacology for XERMELO

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
>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 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 2018/011 Ireland   Start Trial PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEROF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL.; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940 132018000000181 Italy   Start Trial PRODUCT NAME: TELOTRISTAT O UN SUO ESTERE FARMACEUTICAMENTE ACCETTABILE, O UN SUO SALE, IN PARTICOLARE TELOTRISTAT ETILE, PIU IN PARTICOLARE SALE IPPURATO DI TELOTRISAT ETILE(XERMELO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1224, 20170920
2091940 1890014-2 Sweden   Start Trial 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 leading biopharmaceutical companies globally:

Colorcon
Express Scripts
McKinsey
Medtronic
Dow
Harvard Business School

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 verification 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.