You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

GEMTESA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for GEMTESA?
  • What are the global sales for GEMTESA?
  • What is Average Wholesale Price for GEMTESA?
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
Drug patent expirations by year for GEMTESA
Drug Prices for GEMTESA

See drug prices for GEMTESA

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

SponsorPhase
Urovant Sciences GmbHPhase 4

See all GEMTESA clinical trials

Pharmacology for GEMTESA

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

Overview of GEMTESA

GEMTESA, also known as vibegron, is a beta-3 adrenergic receptor agonist approved by the U.S. FDA in December 2020 for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Here’s a detailed look at the market dynamics and financial trajectory of GEMTESA.

Market Size and Growth

The overactive bladder market, in which GEMTESA operates, was valued at $2.2 billion in 2020 across eight major markets, including the US, 5EU (France, Germany, Italy, Spain, and the UK), Japan, and China. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of more than 2% from 2021 to 2030, reaching approximately $2.8 billion by 2030[1][4].

Key Drivers of Market Growth

Several factors are driving the growth of the OAB market, including GEMTESA:

  • Uptake of Novel Therapies: The continued uptake of GEMTESA in the US and Japan, along with its potential launch in China, is a significant driver. GEMTESA has shown promising results in clinical trials, including no statistically significant or clinically meaningful effects on blood pressure or heart rate, which enhances its safety profile[2].
  • Pipeline Agents: The potential launch of other pipeline agents, such as Bayer’s P2X purinoceptor 3 (P2RX3) antagonist Eliapixant, Urovant Sciences’ gene therapy URO-902, and Taiho Pharmaceuticals’ neurite outgrowth enhancer TAC 302, will also contribute to market growth[1].

Market Share and Competition

GEMTESA is part of a competitive market dominated by existing therapies such as Myrbetriq, VESIcare, and Toviaz. Myrbetriq currently holds more than 50% of the global market share in OAB therapies, but GEMTESA is gaining traction due to its efficacy and safety profile. The market share of GEMTESA is expected to increase as it becomes more widely adopted and as other pipeline therapies enter the market[1].

Challenges and Barriers

Despite the positive outlook, there are several challenges that could impact the financial trajectory of GEMTESA:

  • Generic Sales Erosion: Recent and upcoming patent expirations for drugs like VESIcare, Myrbetriq, and Toviaz will lead to generic sales erosion, which could reduce overall market revenue. This erosion is expected to affect key markets, including the US[1][4].
  • Late-Stage Pipeline Scarcity: The lack of drugs in Phase III development or the pre-registration stages will restrict market growth over the early-to-mid forecast period. This scarcity means that there are limited new therapies to offset the revenue losses from generic competition[1][4].
  • Diagnosis and Treatment Barriers: Stigma and misinformation surrounding OAB, as well as poor persistence and adherence to drug therapy, are significant barriers to market growth. These factors deter patients from seeking medical help and reduce the effectiveness of treatments[1].

Financial Performance and Projections

GEMTESA has shown promising financial performance since its launch:

  • Coverage and Access: GEMTESA is covered by 69% of national commercial plans and 85% of Medicare Part D lives in the US, which facilitates patient access and contributes to its financial success[5].
  • Revenue Potential: As a novel therapy with a strong safety and efficacy profile, GEMTESA is expected to capture a significant share of the growing OAB market. Its approval and launch in the US in 2021 have already started to contribute to its revenue growth[2][5].

Clinical and Safety Profile

The clinical and safety profile of GEMTESA is a crucial factor in its market success:

  • Ambulatory Blood Pressure Study: A dedicated study showed that GEMTESA did not have statistically significant or clinically meaningful effects on blood pressure or heart rate, which is a significant advantage over other therapies that may have cardiovascular side effects[2].
  • EMPOWUR Trial: The Phase 3 EMPOWUR trial demonstrated that GEMTESA significantly reduced daily urgency episodes and urinary frequency in patients with OAB, both with and without urinary urge incontinence[2].

Patient Support and Access

To enhance patient access and adherence, Sumitovant Biopharma, the parent company of Urovant Sciences, offers various support resources:

  • Patient Access Programs: These programs include tools to improve access to GEMTESA, resources to identify payor coverage, and insights to help patients overcome financial challenges and stay on therapy[5].

Key Takeaways

  • Market Growth: The OAB market is expected to grow at a CAGR of more than 2% from 2021 to 2030.
  • Novel Therapies: GEMTESA and other pipeline agents are driving market growth.
  • Challenges: Generic sales erosion, late-stage pipeline scarcity, and diagnosis/treatment barriers are significant challenges.
  • Financial Performance: GEMTESA has strong coverage and access, contributing to its revenue growth.
  • Clinical Profile: GEMTESA has a favorable safety and efficacy profile, particularly regarding blood pressure and heart rate.

FAQs

Q: What is GEMTESA, and how is it used? A: GEMTESA (vibegron) is a beta-3 adrenergic receptor agonist used to treat overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Q: What are the key drivers of market growth for GEMTESA? A: The continued uptake of GEMTESA in the US and Japan, its potential launch in China, and the potential launch of other pipeline agents are key drivers.

Q: How does GEMTESA compare to other OAB therapies in terms of safety? A: GEMTESA has shown no statistically significant or clinically meaningful effects on blood pressure or heart rate, making it a safer option compared to some other therapies.

Q: What challenges might affect the financial trajectory of GEMTESA? A: Generic sales erosion, late-stage pipeline scarcity, and barriers to diagnosis and treatment are significant challenges.

Q: How is patient access to GEMTESA supported? A: Sumitovant Biopharma offers various patient access programs, including tools to improve access, resources to identify payor coverage, and insights to help patients overcome financial challenges.

Sources

  1. GlobalData, "Overactive Bladder: Global Drug Forecast and Market Analysis to 2030"
  2. Biospace, "Urovant Sciences Presents Positive Ambulatory Blood Pressure Data Showing That GEMTESA® (vibegron) 75 mg in Overactive Bladder Was Not Associated with Statistically Significant or Clinically Meaningful Effects on Blood Pressure or Heart Rate"
  3. GlobalData, "Net Present Value Model: Gemtesa"
  4. Pharmaceutical Technology, "Overactive bladder market to undergo moderate growth, reaching $2.8bn by 2030"
  5. GEMTESA, "Patient Access & Support Resources"

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

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.