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Last Updated: August 17, 2022

XERMELO Drug Patent Profile


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Which patents cover Xermelo, and what generic alternatives are available?

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 27, 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: 44
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 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
Aman ChauhanPhase 2
University of ChicagoPhase 2
IpsenPhase 3

See all XERMELO clinical trials

Pharmacology for XERMELO

US Patents and Regulatory Information for XERMELO

XERMELO is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XERMELO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: 8558
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08304439
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0817270
Estimated Expiration: See Plans and Pricing

Canada

Patent: 00835
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002880
Estimated Expiration: See Plans and Pricing

China

Patent: 1809018
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 70325
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 03444
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010076
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7275
Estimated Expiration: See Plans and Pricing

Patent: 1070410
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 03444
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 45023
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4373
Estimated Expiration: See Plans and Pricing

Japan

Patent: 17445
Estimated Expiration: See Plans and Pricing

Patent: 10540551
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10003326
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3808
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090742
Estimated Expiration: See Plans and Pricing

Poland

Patent: 03444
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 03444
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1644657
Estimated Expiration: See Plans and Pricing

Patent: 100063736
Estimated Expiration: See Plans and Pricing

Spain

Patent: 31928
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 39457
Estimated Expiration: See Plans and Pricing

Patent: 0922934
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2079
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 364
Estimated Expiration: See Plans and Pricing

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
Uruguay 31364 FORMAS SOLIDAS DE (S)-2-AMINO-3-(4-2-AMINO-6-((R)1-(4-CLORO-2-(3-METIL-1H-PIRAZOL-1-IL)FENIL)-2,2,2-TRIFLUOROTOXI)-PIRIMIDIN-4-IL)FENIL)PROPANOATO DE ETILIO Y METODOS PARA SU USO. See Plans and Pricing
Colombia 6220855 COMPUESTO A BASE DE 54 -FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRIMIDINA Y METODOS PARA SU EMPLEO See Plans and Pricing
European Patent Office 2589600 Composés 4-phényle-6-(2,2,2-trifluoro-1-phényléthoxy) à base de pyrimidine et procédés concernant leur utilisation (4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use) See Plans and Pricing
Argentina 068558 FORMAS SOLIDAS DE (S)-2-AMINO-3-(4-(-AMINO-6-((R)-1-(4-CLORO-2-(3-METIL-1H-PIRAZOL-1-IL)FENIL)-2,2,2-TRIFLUOROETOXI)PIRIMIDIN-4-IL)FENIL)PROPANOATO DE ETILO Y METODOS PARA SU USO See Plans and Pricing
Taiwan 200831102 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use See Plans and Pricing
Hungary E053098 See Plans and Pricing
>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 See Plans and Pricing 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 C201830016 Spain See Plans and Pricing 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 CA 2018 00011 Denmark See Plans and Pricing 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 122018000025 Germany See Plans and Pricing PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940 C 2018 007 Romania See Plans and Pricing PRODUCT NAME: TELOTRISTAT SAU UN ESTER ACCEPTABIL FARMACEUTIC, SAU O SARE A ACESTUIA, IN PARTICULAR ETIL TELOTRISTAT, MAI PARTICULAR SARE HIPURAT DE ETIL TELOTRISTAT; NATIONAL AUTHORISATION NUMBER: EU/1/17/1224; DATE OF NATIONAL AUTHORISATION: 20170918; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1224; DATE OF FIRST AUTHORISATION IN EEA: 20170918
2091940 2018C/009 Belgium See Plans and Pricing DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
AstraZeneca
Medtronic
Baxter
Mallinckrodt

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.