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 will be eligible for patent challenges on December 23, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 1, 2030. 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: | 31 |
| 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
*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 ⤷ 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 GEMTESA
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
Hydroxymethyl pyrrolidines as .beta.3 adrenergic receptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY
Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting GEMTESA
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 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: ⤷ Sign Up
Australia
Patent: 09231714
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 35521
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 2056917
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Sign Up
Patent: 2391255
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 31440
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGOSNISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 751
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA3
Estimated Expiration: ⤷ Sign Up
Patent: 120282
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0120129
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 12552
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 76756
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 010000294
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Patent: 013000267
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010518
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
El Salvador
Patent: 10003687
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0135
Patent: ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ БЕТА 3 (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Sign Up
Patent: 1071169
Patent: ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Georgia, Republic of
Patent: 0125666
Patent: HYDROXYMETHYL PYRROLIDINES AS β3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Honduras
Patent: 10002030
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 47099
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Japan
Patent: 83867
Estimated Expiration: ⤷ Sign Up
Patent: 83870
Estimated Expiration: ⤷ Sign Up
Patent: 32846
Estimated Expiration: ⤷ Sign Up
Patent: 11201897
Patent: HYDROXYMETHYL PYRROLIDINE AS BETA 3 ADRENERGIC RECEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Patent: 11510023
Estimated Expiration: ⤷ Sign Up
Patent: 12020961
Patent: HYDROXYMETHYL PYRROLIDINE AS β3 ADRENOCEPTOR AGONIST
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10010929
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3. (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 988
Patent: HIDROKSIMETIL PIROLIDINI KAO AGONISTI BETA 3 ADRENERGIČKOG RECEPTORA (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 257
Patent: هيدروكسيميتيل بيروليدين كمحفزات مستقبلات بيتا الأدرينالية-3.
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8266
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Nicaragua
Patent: 1000164
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3.
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 091825
Patent: HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 76756
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 76756
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 175
Patent: HIDROKSIMETIL PIROLIDINI KAO AGONISTI BETA 3 ADRENERGIČKOG RECEPTORA (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 8883
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 76756
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1006720
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1288798
Estimated Expiration: ⤷ Sign Up
Patent: 1331771
Estimated Expiration: ⤷ Sign Up
Patent: 100126860
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Patent: 120104257
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Patent: 120118086
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 76278
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 78098
Estimated Expiration: ⤷ Sign Up
Patent: 0944521
Patent: Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000447
Patent: HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS
Estimated Expiration: ⤷ Sign Up
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: ⤷ 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 GEMTESA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Eurasian Patent Organization | 201992690 | ПРИМЕНЕНИЕ ВИБЕГРОНА ДЛЯ ЛЕЧЕНИЯ ГИПЕРАКТИВНОГО МОЧЕВОГО ПУЗЫРЯ | ⤷ Sign Up |
| Singapore | 188883 | HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS | ⤷ Sign Up |
| Ecuador | SP10010518 | HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3 | ⤷ Sign Up |
| Eurasian Patent Organization | 201071169 | ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3 | ⤷ Sign Up |
| China | 117695287 | 使用维贝隆以治疗膀胱过度活动症 (Use of viberon to treat overactive bladder) | ⤷ Sign Up |
| Spain | 2376278 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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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