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
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 |
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
Sponsor | Phase |
---|---|
Aman Chauhan | Phase 2 |
University of Chicago | Phase 2 |
European Organisation for Research and Treatment of Cancer - EORTC | Phase 3 |
Pharmacology for XERMELO
Drug Class | Tryptophan Hydroxylase Inhibitor |
Mechanism of Action | Tryptophan Hydroxylase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 | ||||
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2008073933 | ⤷ Try a Trial | |
Portugal | 2203444 | ⤷ Try a Trial | |
Australia | 2008304439 | Solids 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 |
European Patent Office | 3808740 | 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) | ⤷ Try a Trial |
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) | ⤷ 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 | 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 | 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 | 2018C/009 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2091940 | SPC/GB18/009 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: TELOTRISTAT OR A PHARMACEUTICALLY ACCEPTABLE ESTER, OR A SALT THEREOF, IN PARTICULAR TELOTRISTAT ETHYL, MORE PARTICULARLY HIPPURATE SALT OF TELOTRISTAT ETHYL; REGISTERED: UK EU/1/17/1224/001-002 20170920; UK PLGB 28247/0008 20170920 |
2091940 | 2018/011 | Ireland | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |