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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 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 December 1, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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

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

US Patents and Regulatory Information for GEMTESA

GEMTESA is protected by three 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.

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

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
Ukraine	101367	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)
Eurasian Patent Organization	201992690	ПРИМЕНЕНИЕ ВИБЕГРОНА ДЛЯ ЛЕЧЕНИЯ ГИПЕРАКТИВНОГО МОЧЕВОГО ПУЗЫРЯ
Georgia, Republic of	P20125666	HYDROXYMETHYL PYRROLIDINES AS β3 ADRENERGIC RECEPTOR AGONISTS
Slovenia	2276756
Taiwan	200944521	Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Argentina	072043	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.
South Korea	20120118086	HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS

GEMTESA Market Analysis and Financial Projection Experimental

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"