GEMTESA Drug Patent Profile
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When do Gemtesa patents expire, and when can generic versions of Gemtesa launch?
Gemtesa is a drug marketed by Urovant and is included in one NDA. There are three patents protecting this drug.
This drug has seventy-three patent family members in forty-one countries.
The generic ingredient in GEMTESA is vibegron. One supplier is listed for this compound. Additional details are available on the vibegron profile page.
DrugPatentWatch® Generic Entry Outlook for Gemtesa
Gemtesa was eligible for patent challenges on December 23, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 2, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for GEMTESA
International Patents: | 73 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 1 |
Patent Applications: | 33 |
Drug Prices: | Drug price information for GEMTESA |
What excipients (inactive ingredients) are in GEMTESA? | GEMTESA excipients list |
DailyMed Link: | GEMTESA at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GEMTESA
Generic Entry Date for GEMTESA*:
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 GEMTESA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Urovant Sciences GmbH | Phase 4 |
Pharmacology for GEMTESA
Drug Class | beta3-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta3-Agonists |
US Patents and Regulatory Information for GEMTESA
GEMTESA is protected by three US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GEMTESA is ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 GEMTESA
When does loss-of-exclusivity occur for GEMTESA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2043
Patent: DERIVADOS HETEROCICLICOS DE HIDROXIMETIL PIRROLIDINAS, AGONISTAS DE RECEPTORES ADRENERGICOS BETA 3, COMPOSICIONES FARMACEUTICAS QUE LOS COMPRENDEN Y USO DE LOS MISMOS EN EL TRATAMIENTO DE TRASTORNOS DEL APARTO URINARIO.
Estimated Expiration: ⤷ Try for Free
Australia
Patent: 09231714
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Try for Free
Austria
Patent: 35521
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 0909768
Patent: composto, composição farmacêutica, método para o tratamento ou prevenção de uma doença ou distúrbio mediados pela ativação de b3-adrenoceptor, e, uso de um composto""composto, composição farmacêutica, método para o tratamento ou orevenção de uma doença ou distúrbio mediados pela ativação de b3-adrenoceptor, e, uso de um composto
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 19876
Patent: HYDROXYMETHYL PYRROLIDINES EN TANT QU'AGONISTES DE RECEPTEUR BETA 3 ADRENERGIQUE (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 09000815
Patent: Compuestos derivados de fenilhidroximetilpirrolidina, agonista del recptor adrenergico beta 3; composicion farmaceutica que los comprende; uso en el tratamiento de vejiga hiperactiva, incontinencia urinaria por impulso y urgencia urinaria.
Estimated Expiration: ⤷ Try for Free
China
Patent: 2056917
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Try for Free
Patent: 2391255
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 31440
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGOSNISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Costa Rica
Patent: 751
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA3
Estimated Expiration: ⤷ Try for Free
Patent: 120282
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Croatia
Patent: 0120129
Estimated Expiration: ⤷ Try for Free
Cyprus
Patent: 12552
Estimated Expiration: ⤷ Try for Free
Denmark
Patent: 76756
Estimated Expiration: ⤷ Try for Free
Dominican Republic
Patent: 010000294
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Patent: 013000267
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Ecuador
Patent: 10010518
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
El Salvador
Patent: 10003687
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Eurasian Patent Organization
Patent: 0135
Patent: ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ БЕТА 3 (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
Patent: 1071169
Patent: ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 76756
Patent: HYDROXYMÉTHYL PYRROLIDINES EN TANT QU`AGONISTES DE RÉCEPTEUR BÊTA 3 ADRÉNERGIQUE (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
Georgia, Republic of
Patent: 0125666
Patent: HYDROXYMETHYL PYRROLIDINES AS β3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Honduras
Patent: 10002030
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Hong Kong
Patent: 47099
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8215
Patent: הידרוקסימתיל פירולידינים, הרכב רוקחי המכיל אותם ושימוש שלהם להכנת תרופה (Hydroxymethyl pyrrolidines, pharmaceutical compositions comprising same and use thereof for preparation of medicaments)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 83867
Estimated Expiration: ⤷ Try for Free
Patent: 83870
Estimated Expiration: ⤷ Try for Free
Patent: 32846
Estimated Expiration: ⤷ Try for Free
Patent: 11201897
Patent: HYDROXYMETHYL PYRROLIDINE AS BETA 3 ADRENERGIC RECEPTOR AGONIST
Estimated Expiration: ⤷ Try for Free
Patent: 11510023
Estimated Expiration: ⤷ Try for Free
Patent: 12020961
Patent: HYDROXYMETHYL PYRROLIDINE AS β3 ADRENOCEPTOR AGONIST
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 10010929
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3. (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS.)
Estimated Expiration: ⤷ Try for Free
Montenegro
Patent: 988
Patent: HIDROKSIMETIL PIROLIDINI KAO AGONISTI BETA 3 ADRENERGIČKOG RECEPTORA (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
Morocco
Patent: 257
Patent: هيدروكسيميتيل بيروليدين كمحفزات مستقبلات بيتا الأدرينالية-3.
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 8266
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Nicaragua
Patent: 1000164
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3.
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 091825
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 76756
Estimated Expiration: ⤷ Try for Free
Portugal
Patent: 76756
Estimated Expiration: ⤷ Try for Free
Serbia
Patent: 175
Patent: HIDROKSIMETIL PIROLIDINI KAO AGONISTI BETA 3 ADRENERGIČKOG RECEPTORA (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 8883
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Slovenia
Patent: 76756
Estimated Expiration: ⤷ Try for Free
South Africa
Patent: 1006720
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 1288798
Estimated Expiration: ⤷ Try for Free
Patent: 1331771
Estimated Expiration: ⤷ Try for Free
Patent: 100126860
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Patent: 120104257
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Patent: 120118086
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 76278
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 78098
Estimated Expiration: ⤷ Try for Free
Patent: 0944521
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Try for Free
Tunisia
Patent: 10000447
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Try for Free
Ukraine
Patent: 1367
Patent: ГІДРОКСИМЕТИЛПІРОЛІДИНИ ЯК АГОНІСТИ АДРЕНЕРГІЧНИХ РЕЦЕПТОРІВ β3[Normal;heading 1;heading 2;heading 3;ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ КАК АГОНИСТЫ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3 (Normal;heading 1;heading 2;heading 3;HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Try for Free
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 GEMTESA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101288798 | ⤷ Try for Free | |
Mexico | 2022015629 | USO DE VIBEGRON PARA TRATAR VEJIGA SOBREACTIVA. (USE OF VIBEGRON TO TREAT OVERACTIVE BLADDER.) | ⤷ Try for Free |
Nicaragua | 201000164 | HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3. | ⤷ Try for Free |
Israel | 271164 | שימוש בויבגרון לטפל בשלפוחית שתן עם פעילות יתר (Use of vibegron to treat overactive bladder) | ⤷ Try for Free |
South Korea | 20100126860 | HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for GEMTESA
More… ↓