XERMELO Drug Patent Profile
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When do Xermelo patents expire, 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 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
*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 |
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 ⤷ 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 |
|---|---|---|---|
| Israel | 204373 | צורות מוצקות של (s) - אתיל - 2 - אמינו - 3 - (4 - (2 - אמינו - 6 - ((r) - 1 - (4 - כלורו - 2 - o - מתיל - 1h - פיראזול - 1 - יל) פניל) -2, 2, 2 - טריפלואוראתוקסי - פירימידין - 4 - יל) פניל) פרופנואט (Solid forms of ( s) -ethyl 2-amino-3- (4- (2 -amino- 6- ( (r) -1- (4-chloro-2- o-methyl-1h-pyrazol- 1-yl) phenyl) -2, 2, 2-trifluorethoxy) -pyrimidin-4-yl) phenyl) propanoate) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2009042733 | ⤷ Sign Up | |
| Taiwan | 200922934 | 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)-pyrimidin-4-yl)phenyl)propanoate and methods of their use | ⤷ 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 | 18C1009 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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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