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 two patents protecting this drug.
This drug has fifty-six patent family members in forty 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
Summary for GEMTESA
| International Patents: | 56 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Clinical Trials: | 1 |
| Patent Applications: | 39 |
| 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 two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GEMTESA 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 GEMTESA
Hydroxymethyl pyrrolidines as .beta.3 adrenergic receptor agonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting GEMTESA
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Urovant | GEMTESA | vibegron | TABLET;ORAL | 213006-001 | Dec 23, 2020 | 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 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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09231714
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 5521
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0909768
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 19876
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 09000815
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2056917
Estimated Expiration: ⤷ Try a Trial
Patent: 2391255
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 31440
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 751
Estimated Expiration: ⤷ Try a Trial
Patent: 120282
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0120129
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12552
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 76756
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 010000294
Estimated Expiration: ⤷ Try a Trial
Patent: 013000267
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010518
Estimated Expiration: ⤷ Try a Trial
El Salvador
Patent: 10003687
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 0135
Estimated Expiration: ⤷ Try a Trial
Patent: 1071169
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 76756
Estimated Expiration: ⤷ Try a Trial
Georgia, Republic of
Patent: 0125666
Estimated Expiration: ⤷ Try a Trial
Honduras
Patent: 10002030
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 47099
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 8215
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 83867
Estimated Expiration: ⤷ Try a Trial
Patent: 83870
Estimated Expiration: ⤷ Try a Trial
Patent: 32846
Estimated Expiration: ⤷ Try a Trial
Patent: 11201897
Estimated Expiration: ⤷ Try a Trial
Patent: 11510023
Estimated Expiration: ⤷ Try a Trial
Patent: 12020961
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10010929
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 988
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 257
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8266
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1000164
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 091825
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 76756
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 76756
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 175
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 8883
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 76756
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1006720
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1288798
Estimated Expiration: ⤷ Try a Trial
Patent: 1331771
Estimated Expiration: ⤷ Try a Trial
Patent: 100126860
Estimated Expiration: ⤷ Try a Trial
Patent: 120104257
Estimated Expiration: ⤷ Try a Trial
Patent: 120118086
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 76278
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 78098
Estimated Expiration: ⤷ Try a Trial
Patent: 0944521
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000447
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1367
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 GEMTESA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Colombia | 6331440 | HIDROXIMETIL PIRROLIDINAS COMO AGOSNISTAS DEL RECEPTOR ADRENERGICO BETA 3 | ⤷ Try a Trial |
| Montenegro | 01988 | HIDROKSIMETIL PIROLIDINI KAO AGONISTI BETA 3 ADRENERGIČKOG RECEPTORA (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS) | ⤷ Try a Trial |
| El Salvador | 2010003687 | HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3 | ⤷ Try a Trial |
| Costa Rica | 20120282 | HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENÉRGICO BETA 3 | ⤷ Try a Trial |
| >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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