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Last Updated: March 28, 2024

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XERMELO Drug Patent Profile


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When do Xermelo patents expire, 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: 70
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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Tersera XERMELO telotristat etiprate TABLET;ORAL 208794-001 Feb 28, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

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

Brazil

Patent: 0720270
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 72233
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 20855
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 91940
Estimated Expiration: ⤷  Try a Trial

Patent: 76159
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 099413
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8150
Estimated Expiration: ⤷  Try a Trial

Patent: 0970575
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 91940
Estimated Expiration: ⤷  Try a Trial

Patent: 89600
Estimated Expiration: ⤷  Try a Trial

Patent: 76159
Estimated Expiration: ⤷  Try a Trial

Patent: 08740
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 27896
Estimated Expiration: ⤷  Try a Trial

Patent: 53098
Estimated Expiration: ⤷  Try a Trial

Patent: 800010
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8806
Estimated Expiration: ⤷  Try a Trial

Patent: 5288
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 61734
Estimated Expiration: ⤷  Try a Trial

Patent: 10512416
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 09006195
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0929
Estimated Expiration: ⤷  Try a Trial

New Zealand

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

Norway

Patent: 5062
Estimated Expiration: ⤷  Try a Trial

Patent: 21010
Estimated Expiration: ⤷  Try a Trial

Patent: 092639
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 91940
Estimated Expiration: ⤷  Try a Trial

Patent: 76159
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 91940
Estimated Expiration: ⤷  Try a Trial

Patent: 76159
Estimated Expiration: ⤷  Try a Trial

South Africa

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

South Korea

Patent: 1464391
Estimated Expiration: ⤷  Try a Trial

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

Spain

Patent: 62775
Estimated Expiration: ⤷  Try a Trial

Patent: 25083
Estimated Expiration: ⤷  Try a Trial

Patent: 56871
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 12365
Estimated Expiration: ⤷  Try a Trial

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

Ukraine

Patent: 270
Estimated Expiration: ⤷  Try a Trial

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
Hungary S1800010 ⤷  Try a Trial
Peru 20090742 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-TRIFLUOROETOXI)-PIRIMIDIN-4-IL)FENIL)PROPANOATO DE ETILO Y METODOS PARA SU USO ⤷  Try a Trial
Japan 2010540551 ⤷  Try a Trial
Spain 2625083 ⤷  Try a Trial
New Zealand 583808 CRYSTALLINE FORMS OF (S) -ETHYL 2-AMINO-3- (4- (2 -AMINO- 6- ( (R) -1- (4-CHLORO-2- O-METHYL-IH-PYRAZOL- 1-YL) PHENYL) -2, 2, 2-TRIFLUORETHOXY) -PYRIMIDIN-4-YL) PHENYL) PROPANOATE ⤷  Try a Trial
Mexico 2010003326 FORMAS SOLIDAS DE (S)-ETIL 2-AMINO-3-(4-(2-AMINO-6-((R)-1-(4-CLORO -2-(3-METIL-1H-PIRAZOL-1-IL)FENIL)-2,2,2-TRIFLUOROETOXI)-PIRIMIDI N-4-IL)FENIL)PROPANOATO Y METODOS DE SU USO. (SOLIDS FORMS OF ( S) -ETHYL 2-AMIN0-3- (4- (2 -AMINO- 6- ( (R) -1- (4-CHL0R0-2- O-METHYL-IH-PYRAZOL- 1-YL) PHENYL) -2, 2, 2-TRIFLUORETHOXY) -PYRIMIDIN-4-YL) PHENYL) PROPANOATE.) ⤷  Try a Trial
Hungary E027896 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XERMELO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2091940 C201830016 Spain ⤷  Try a Trial 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 122018000025 Germany ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH TELOTRISTATETHYL; REGISTRATION NO/DATE: EU/1/17/1224 20170918
2091940 300929 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2091940 1890014-2 Sweden ⤷  Try a 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
2091940 18C1009 France ⤷  Try a Trial PRODUCT NAME: TELOTRISTAT OU L'UN DE SES ESTERS PHARMACEUTIQUEMENT ACCEPTABLES, OU L'UN DE LEURS SELS, EN PARTICULIER LE TELOTRISTAT D'ETHYLE ET PLUS PARTICULIEREMENT L'HIPPURATE DE TELOTRISTAT D'ETHYLE; REGISTRATION NO/DATE: EU/1/17/1224 20170920
2091940 11/2018 Austria ⤷  Try a 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 2018C/009 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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