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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Questions you can ask:
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XERMELO
*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
| Sponsor | Phase |
|---|---|
| Aman Chauhan | Phase 2 |
| University of Chicago | Phase 2 |
| Ipsen | Phase 3 |
Pharmacology for XERMELO
| Drug Class | Tryptophan Hydroxylase Inhibitor |
| Mechanism of Action | Tryptophan Hydroxylase Inhibitors |
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 | ||||
| Tersera | XERMELO | telotristat etiprate | TABLET;ORAL | 208794-001 | Feb 28, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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
Patent: COMPUESTOS BASADOS EN LA 4-FENIL-6-(2,2,2-TRIFLUORO-1- FENILETOXI) PIRIMIDINA Y METODOS DE USO DE LOS MISMOS
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
Patent: COMPOSTOS BASEDOS EM 4-FENIL-6-(2,2,2-TRIFLÚOR-1-FENIL ETOXI) PIRIMIDINA E PROCESSOS DE USOS DOS MESMOS
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 72233
Patent: COMPOSES 4-PHENYLE-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY) A BASEDE PYRIMIDINE ET PROCEDES CONCERNANT LEUR UTILISATION (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 20855
Patent: COMPUESTO A BASE DE 54 -FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRIMIDINA Y METODOS PARA SU EMPLEO
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 91940
Estimated Expiration: ⤷ Sign Up
Patent: 76159
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 099413
Patent: COMPUESTOS A BASE DE 4 - fenil - 6 - (2,2,2 - trifluoro - 1 - feniletoxi)pirimidina Y MÉTODOS PARA SU EMPLEO
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 8150
Patent: СОЕДИНЕНИЯ НА ОСНОВЕ 4-ФЕНИЛ-6-(2,2,2-ТРИФТОР-1-ФЕНИЛЭТОКСИ)ПИРИМИДИНА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE)
Estimated Expiration: ⤷ Sign Up
Patent: 0970575
Patent: СОЕДИНЕНИЯ НА ОСНОВЕ 4-ФЕНИЛ-6-(2,2,2-ТРИФТОР-1-ФЕНИЛЭТОКСИ)ПИРИМИДИНА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 91940
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 89600
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Patent: 76159
Patent: COMPOSÉS À BASE DE PYRIMIDINE 4-PHÉNYL-6- (2,2,2-TRIFLUORO-1-PHÉNYLÉTHOXY) ET LEURS PROCÉDÉS D'UTILISATION (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE)
Estimated Expiration: ⤷ Sign Up
Patent: 08740
Patent: FORME POSOLOGIQUE ORALE COMPRENNENT DES COMPOSÉS À BASE DE PYRIMIDINE 4-PHÉNYL-6- (2,2,2-TRIFLUORO-1-PHÉNYLÉTHOXY) ET LEURS PROCÉDÉS D'UTILISATION (ORAL DOSAGE FORMS COMPRISING 4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE)
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
Patent: תרכובות מבוססות 4-פניל-6-(2,2,2-טריפלואורו-1-פנילאתוקסי)פירימידין-2-אמחינו-חומצה פרופנואית, תכשירים המכילים אותן ושימושים בהן (4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-2-amino-propanoic acid based compounds, compositions comprising them and uses thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 5288
Patent: צורת מינון המכילה תרכובות המבוססות על 4-פניל-6-(2,2,2-טריפלואורו-1-פנילאתוקסי)פירימידין (Dosage form containing 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 61734
Estimated Expiration: ⤷ Sign Up
Patent: 10512416
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09006195
Patent: COMPUESTOS BASADOS EN 4-FENIL-6-(2,2,2-TRIFLUORO-1-FENILETOXI)PIRI MIDINA Y METODOS DE SU USO. (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE.)
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
Patent: СПОЛУКИ НА ОСНОВІ 4-ФЕНІЛ-6-(2,2,2-ТРИФТОР-1-ФЕНІЛЕТОКСИ)ПІРИМІДИНУ І ЇХ ЗАСТОСУВАННЯ[СОЕДИНЕНИЯ НА ОСНОВЕ 4-ФЕНИЛ-6-(2,2,2-ТРИФТОР-1-ФЕНИЛЕТОКСИ)ПИРИМИДИНА И ИХ ПРИМЕНЕНИЕ (4-PHENYL-6-(2,2,2-TRIFLUORO-1-PHENYLETHOXY)PYRIMIDINE-BASED COMPOUNDS AND METHODS OF THEIR USE)
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 |
|---|---|---|---|
| Portugal | 2091940 | ⤷ Sign Up | |
| Netherlands | 300929 | ⤷ Sign Up | |
| Japan | 2010540551 | ⤷ Sign Up | |
| Eurasian Patent Organization | 201070410 | ТВЕРДЫЕ ФОРМЫ (S)-ЭТИЛ-2-АМИНО-3-(4-(2-АМИНО-6-((R)-1-(4-ХЛОР-2-(3-МЕТИЛ-1H-ПИРАЗОЛ-1-ИЛ)ФЕНИЛ)-2,2,2-ТРИФТОРЭТОКСИ)ПИРИМИДИН-4-ИЛ)ФЕНИЛ)ПРОПАНОАТА И СПОСОБЫ ИХ ПРИМЕНЕНИЯ | ⤷ Sign Up |
| Portugal | 3176159 | ⤷ 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 | 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 |
| 2091940 | 2018C/009 | Belgium | ⤷ Sign Up | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2091940 | C 2018 007 | Romania | ⤷ Sign Up | 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 | 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 | 713 | Finland | ⤷ Sign Up | |
| >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.
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