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Last Updated: October 1, 2022

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-five patent family members in forty countries.

The generic ingredient in GEMTESA is vibegron. 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:55
US Patents:2
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 19
Clinical Trials: 1
Patent Applications: 39
What excipients (inactive ingredients) are in GEMTESA?GEMTESA excipients list
DailyMed Link:GEMTESA at DailyMed
Drug patent expirations by year for GEMTESA
DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
Urovant Sciences GmbHPhase 4

See all GEMTESA clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting GEMTESA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Urovant GEMTESA vibegron TABLET;ORAL 213006-001 Dec 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Urovant GEMTESA vibegron TABLET;ORAL 213006-001 Dec 23, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 09231714
Estimated Expiration: See Plans and Pricing

Austria

Patent: 5521
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0909768
Estimated Expiration: See Plans and Pricing

Canada

Patent: 19876
Estimated Expiration: See Plans and Pricing

Chile

Patent: 09000815
Estimated Expiration: See Plans and Pricing

China

Patent: 2056917
Estimated Expiration: See Plans and Pricing

Patent: 2391255
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 31440
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 751
Estimated Expiration: See Plans and Pricing

Patent: 120282
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0120129
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12552
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 76756
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 010000294
Estimated Expiration: See Plans and Pricing

Patent: 013000267
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010518
Estimated Expiration: See Plans and Pricing

El Salvador

Patent: 10003687
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0135
Estimated Expiration: See Plans and Pricing

Patent: 1071169
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 76756
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0125666
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 10002030
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 47099
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8215
Estimated Expiration: See Plans and Pricing

Japan

Patent: 83867
Estimated Expiration: See Plans and Pricing

Patent: 83870
Estimated Expiration: See Plans and Pricing

Patent: 32846
Estimated Expiration: See Plans and Pricing

Patent: 11201897
Estimated Expiration: See Plans and Pricing

Patent: 11510023
Estimated Expiration: See Plans and Pricing

Patent: 12020961
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10010929
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 988
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 257
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8266
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1000164
Estimated Expiration: See Plans and Pricing

Peru

Patent: 091825
Estimated Expiration: See Plans and Pricing

Poland

Patent: 76756
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 76756
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 175
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 8883
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 76756
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1006720
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1288798
Estimated Expiration: See Plans and Pricing

Patent: 1331771
Estimated Expiration: See Plans and Pricing

Patent: 100126860
Estimated Expiration: See Plans and Pricing

Patent: 120104257
Estimated Expiration: See Plans and Pricing

Patent: 120118086
Estimated Expiration: See Plans and Pricing

Spain

Patent: 76278
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 78098
Estimated Expiration: See Plans and Pricing

Patent: 0944521
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000447
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1367
Estimated Expiration: See Plans and Pricing

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
Austria 535521 See Plans and Pricing
Canada 2719876 HYDROXYMETHYL PYRROLIDINES EN TANT QU'AGONISTES DE RECEPTEUR BETA 3 ADRENERGIQUE (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS) See Plans and Pricing
South Africa 201006720 HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS See Plans and Pricing
Mexico 2010010929 HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3. (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS.) See Plans and Pricing
China 102391255 Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists See Plans and Pricing
Georgia, Republic of P20125666 HYDROXYMETHYL PYRROLIDINES AS β3 ADRENERGIC RECEPTOR AGONISTS See Plans and Pricing
Hong Kong 1147099 HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Baxter
Express Scripts
Mallinckrodt
Moodys

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.