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GEMTESA Drug Patent Profile

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. 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:	55
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

See drug prices for GEMTESA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GEMTESA

NDA:

213006

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

See all GEMTESA clinical trials

Pharmacology for GEMTESA

Drug Class	beta3-Adrenergic Agonist
Mechanism of Action	Adrenergic beta3-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for GEMTESA

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for GEMTESA

GEMTESA is protected by two US patents and one FDA Regulatory Exclusivity.

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

FDA Regulatory Exclusivity protecting GEMTESA

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			Y	Y
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes				Y
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes

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

Australia

Austria

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Honduras

Hong Kong

Israel

Japan

Mexico

Montenegro

Morocco

New Zealand

Nicaragua

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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
China	102391255	Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
South Korea	101288798
Taiwan	200944521	Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
El Salvador	2010003687	HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
Eurasian Patent Organization	201071169	ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ В КАЧЕСТВЕ АГОНИСТОВ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3
Canada	2719876	HYDROXYMETHYL PYRROLIDINES EN TANT QU'AGONISTES DE RECEPTEUR BETA 3 ADRENERGIQUE (HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)
Dominican Republic	P2010000294	HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3