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Last Updated: June 14, 2024

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XERMELO Drug Patent Profile


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Which patents cover Xermelo, and when can generic versions of Xermelo launch?

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

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

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

DrugPatentWatch® Generic Entry Outlook for Xermelo

Xermelo was eligible for patent challenges on February 28, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XERMELO
International Patents:70
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 54
Clinical Trials: 5
Patent Applications: 68
Drug Prices: Drug price information for XERMELO
What excipients (inactive ingredients) are in XERMELO?XERMELO excipients list
DailyMed Link:XERMELO at DailyMed
Drug patent expirations by year for XERMELO
Drug Prices for XERMELO

See drug prices for XERMELO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Aman ChauhanPhase 2
University of ChicagoPhase 2
European Organisation for Research and Treatment of Cancer - EORTCPhase 3

See all XERMELO clinical trials

Pharmacology for XERMELO

US Patents and Regulatory Information for XERMELO

XERMELO is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XERMELO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XERMELO

4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY

Methods of using 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY

Solid forms of (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)-pyrim- idin-4-YL)phenyl)propanoate and methods of their use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phen- yl)-2,2,2-trifluoroethoxy)-pyrimidin-4-yl)phenyl)propanoate and methods of their use
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY

FDA Regulatory Exclusivity protecting XERMELO

TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
Exclusivity Expiration: ⤷  Sign Up

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

International Patents for XERMELO

When does loss-of-exclusivity occur for XERMELO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4279
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 07333120
Patent: 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0720270
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 72233
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 20855
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 91940
Estimated Expiration: ⤷  Sign Up

Patent: 76159
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 099413
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8150
Estimated Expiration: ⤷  Sign Up

Patent: 0970575
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 91940
Estimated Expiration: ⤷  Sign Up

Patent: 89600
Estimated Expiration: ⤷  Sign Up

Patent: 76159
Estimated Expiration: ⤷  Sign Up

Patent: 08740
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27896
Estimated Expiration: ⤷  Sign Up

Patent: 53098
Estimated Expiration: ⤷  Sign Up

Patent: 800010
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8806
Estimated Expiration: ⤷  Sign Up

Patent: 5288
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 61734
Estimated Expiration: ⤷  Sign Up

Patent: 10512416
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 09006195
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0929
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 7004
Patent: 4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 5062
Estimated Expiration: ⤷  Sign Up

Patent: 21010
Estimated Expiration: ⤷  Sign Up

Patent: 092639
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 91940
Estimated Expiration: ⤷  Sign Up

Patent: 76159
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 91940
Estimated Expiration: ⤷  Sign Up

Patent: 76159
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0903367
Patent: 4-Phenyl-6-(2,2,2-trifluoro-1-phenylethoxy) pyrimidine-based compounds and methods of their use
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1464391
Estimated Expiration: ⤷  Sign Up

Patent: 090087916
Patent: 4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 62775
Estimated Expiration: ⤷  Sign Up

Patent: 25083
Estimated Expiration: ⤷  Sign Up

Patent: 56871
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 12365
Estimated Expiration: ⤷  Sign Up

Patent: 0831102
Patent: 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 270
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XERMELO around the world.

Country Patent Number Title Estimated Expiration
Ukraine 102079 ТВЕРДА ФОРМА (S)-ЕТИЛ-2-АМІНО-3-(4-(2-АМІНО-6-((R)-1-(4-ХЛОР-2-(3-МЕТИЛ-1H-ПІРАЗОЛ-1-ІЛ)ФЕНІЛ)-2,2,2-ТРИФТОРЕТОКСИ)ПІРИМІДИН-4-ІЛ)ФЕНІЛ)ПРОПАНОАТУ (ВАРІАНТИ) І СПОСОБИ ЇЇ ЗАСТОСУВАННЯ[ТВЕРДАЯ ФОРМА (S)-ЭТИЛ-2-АМИНО-3-(4-(2-АМИНО-6-((R)-1-(4-ХЛОР-2-(3-МЕТИЛ-1H-ПИРАЗОЛ-1-ИЛ)ФЕНИЛ)-2,2,2-ТРИФТОРЕТОКСИ)ПИРИМИДИН-4-ИЛ)ФЕНИЛ)ПРОПАНОАТА (ВАРИАНТЫ) И СПОСОБЫ ЕЕ ПРИМЕНЕНИЯ (SOLID FORMS OF (S)-ETHYL 2-AMINO-3-(4-(2-AMINO-6-((R)-L-(4-CHLORO-2-(3-METHYL-1H-PYRAZOL-1-YL)PHENYL)-2,2,2-TRIFLUOROETHOXY)PYRIMIDIN-4-YL)PHENYL)PROPANOATE AND METHODS OF USE THEREOF) ⤷  Sign Up
Colombia 6220855 COMPUESTO A BASE DE 54 -FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRIMIDINA Y METODOS PARA SU EMPLEO ⤷  Sign Up
Japan 5717445 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XERMELO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 CR 2018 00011 Denmark ⤷  Sign Up PRODUCT NAME: TELOTRISTAT OR A C1-4 ALKYL ESTER THEREOF, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REG. NO/DATE: EU/1/17/1224 20170920
2091940 C02091940/01 Switzerland ⤷  Sign Up PRODUCT NAME: TELOTRISTAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66374 28.03.2018
2091940 132018000000181 Italy ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.