GEMTESA Drug Patent Profile

When do Gemtesa patents expire, and when can generic versions of Gemtesa launch?

Gemtesa is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and nineteen patent family members in forty-eight 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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for GEMTESA

International Patents:	119
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
Patent Applications:	139
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

Constraining patent/regulatory exclusivity:

8,653,260

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
Wake Forest University Health Sciences	PHASE3
University of Missouri-Columbia	EARLY_PHASE1
Urovant Sciences GmbH	Phase 4

See all GEMTESA clinical trials

Pharmacology for GEMTESA

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

Paragraph IV (Patent) Challenges for GEMTESA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GEMTESA	Tablets	vibegron	75 mg	213006	4	2024-12-23

US Patents and Regulatory Information for GEMTESA

GEMTESA is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,653,260.

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
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	12,102,638
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	8,653,260			Y
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	12,357,636
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	8,247,415		Y	Y
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	12,180,219		Y	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

Finland

France

Georgia, Republic of

Honduras

Hong Kong

Israel

Japan

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

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
Japan	2012020961
Canada	3115190
European Patent Office	3890743
Eurasian Patent Organization	020135
Cyprus	1112552
Hong Kong	1147099
Australia	2019393372

Supplementary Protection Certificates for GEMTESA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2276756	2490045-8	Sweden		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628
2276756	C20240046	Finland
2276756	2024C/551	Belgium		PRODUCT NAME: VIBEGRON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1822 20240628
2276756	122024000082	Germany		PRODUCT NAME: VIBEGRON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1822 20240627
2276756	CA 2024 00054	Denmark		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628
2276756	CR 2024 00054	Denmark		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628
2276756	301305	Netherlands		PRODUCT NAME: VIBEGRON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1822 20240628

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: GEMTESA

Last updated: July 27, 2025

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Introduction

GEMTESA (vibegron) is an oral, selective beta-3 adrenergic receptor agonist approved by the U.S. Food and Drug Administration (FDA) in December 2020 for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. As a relatively recent entrant into the U.S. OAB market, GEMTESA's commercial success hinges on evolving market dynamics, competitive positioning, regulatory pathways, and sales trajectory. This report offers an authoritative analysis of GEMTESA's market ecosystem and its projected financial trajectory.

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Market Landscape for Overactive Bladder (OAB) Treatments

The global OAB market is estimated to reach approximately US$4-5 billion by 2025, driven by increasing prevalence, aging populations, and expanding awareness of bladder health issues. In the U.S., over 33 million adults are affected by OAB, with women representing a significant portion of patients [1].

Pharmaceutical Treatment Options

Historically, antimuscarinics and beta-3 adrenergic agonists, such as mirabegron, comprise the primary pharmacotherapies. Mirabegron, marketed by Allergan (now part of AbbVie), dominates the beta-3 class, commanding substantial market share due to its favorable side-effect profile compared to antimuscarinics.

Market Drivers and Trends

• Aging demographics: Increasing incidence among the elderly bolsters demand.
• Patient preference: Growing inclination toward minimally invasive, well-tolerated medications.
• Regulatory approvals: Expanding labels and indications promote adoption.
• Pricing and reimbursement: Favorable insurance coverage facilitates market penetration.

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GEMTESA’s Competitive Positioning and Market Entry

Initial Launch and Sales Performance

GEMTESA entered a competitive landscape with initial robust expectations. The drug's targeted mechanism, favorable tolerability profile, and once-daily dosing foster strong appeal among patients and clinicians. The FDA approval was supported by pivotal Phase 3 trials demonstrating non-inferiority to mirabegron, with comparable efficacy and easier side-effect management [2].

Pricing Strategy and Reimbursement

Pricing for GEMTESA aligns closely with existing beta-3 agonists; however, reimbursement negotiations with payers are crucial. Early adoption rate metrics suggest that initial pricing was slightly below that of innovator drugs, aiming to accelerate market uptake and establish a foothold in a market dominated by established players.

Market Penetration Challenges

Key barriers include:

• Brand loyalty: Prescriptions for mirabegron and antimuscarinics remain strong.
• Physician familiarity: Clinician inertia and comfort with existing therapies slow uptake.
• Cost-effectiveness: Payers demand robust evidence demonstrating incremental benefit over existing therapies.

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Market Dynamics Influencing GEMTESA's Growth

Competitive Landscape

GEMTESA faces direct competition primarily from mirabegron and antimuscarinic classes such as oxybutynin, tolterodine, and solifenacin. Mirabegron remains the market leader due to its established presence and broad clinician acceptance. Nonetheless, GEMTESA's differentiated profile — once-daily dosing, tolerability, and non-inferior efficacy — positions it as a viable alternative, especially for patients intolerant to antimuscarinics.

Regulatory and Clinical Milestones

The potential expansion of indications could significantly influence market dynamics. Trials exploring GEMTESA for nocturia, hyperhidrosis, or other indications could broaden its application footprint and revenue streams. Conversely, any regulatory delays or safety concerns could hinder market penetration.

Market Adoption Drivers

• Key opinion leader (KOL) endorsements bolster prescribing confidence.
• Patient-centric marketing emphasizing tolerability and convenience.
• Integration into therapy guidelines and clinical pathways.

Pricing and Reimbursement Evolution

Reimbursement trends are pivotal. As more data on GEMTESA's real-world efficiency and cost-effectiveness emerge, payers are likely to develop favorable formularies, encouraging higher prescribing rates.

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Financial Trajectory and Revenue Projections

Initial Sales

Assuming conservative early market capture—estimated at 2-5% of the U.S. OAB market in the first year—initial sales are projected between US$50-100 million. Revenue hinges on prescribing volume growth, pricing strategies, and payer inclusivity.

Medium to Long-term Growth

Over a 3-5 year horizon, as awareness increases and therapeutic guidelines incorporate GEMTESA, market penetration could expand to 10-15%. This growth could translate into annual sales surpassing US$300 million, assuming competitive pricing and the absence of unforeseen regulatory hurdles.

Market Share Dynamics

• The drug could capture 30-40% of the beta-3 agonist segment within 3 years, competing primarily with mirabegron.
• Market share gains depend on differential efficacy, safety profile, and prescriber familiarity.

Factors Influencing Revenue Growth

• Clinical data updates: Positive real-world evidence may accelerate adoption.
• Physician education: Targeted campaigns can boost prescriptions.
• Market expansion: Approval for additional indications or patient populations.

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Strategic Considerations and Future Outlook

Pipeline and Lifecycle Management

Efforts to expand GEMTESA's label, pursue patent protections, and develop next-generation formulations are critical for sustaining revenue growth.

Partnerships and Market Expansion

Potential partnerships for international markets and co-marketing agreements could unlock additional revenue streams, especially in Europe and Asia.

Risks and Uncertainties

• Market entry barriers, clinician inertia, and payer resistance pose ongoing challenges.
• Competition from emerging drugs with superior profiles.
• Regulatory delays or safety issues.

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Key Takeaways

• Market Opportunity: The U.S. overactive bladder market remains sizable, with expanding acceptance of beta-3 adrenergic agents positioning GEMTESA for growth.
• Competitive Positioning: Faced with entrenched competitors, GEMTESA's success will depend on demonstrating clear advantages in tolerability, convenience, and value.
• Sales Trajectory: Early sales are modest but expected to accelerate over the next 3-5 years, potentially reaching hundreds of millions in annual revenue.
• Growth Drivers: Physician adoption influenced by clinical data, reimbursement frameworks, and marketing efforts will shape long-term success.
• Strategic Priorities: Expanding indications, international expansion, and lifecycle management are essential for sustained financial performance.

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FAQs

1. How does GEMTESA compare to existing therapies for overactive bladder?
GEMTESA offers once-daily oral dosing with a tolerability profile comparable or superior to traditional antimuscarinic drugs. Its non-inferiority and favorable safety data make it an attractive alternative, particularly for patients intolerant to anticholinergics.

2. What are the primary barriers to GEMTESA's market growth?
Barriers include entrenched prescribing habits favoring established drugs like mirabegron, payer negotiations, and physician familiarity. Additionally, lack of broad indication expansion limits the market size.

3. What factors could accelerate GEMTESA’s revenue growth?
Positive real-world evidence, additional approvals, inclusion in clinical guidelines, and strategic partnerships can catalyze rapid adoption and sales expansion.

4. How significant is GEMTESA’s market potential outside the U.S.?
International markets, especially Europe and Asia, represent substantial growth opportunities once regulatory approvals are obtained and localized marketing strategies are implemented.

5. What are the risks associated with GEMTESA’s long-term financial prospects?
Risks include competitive advances, payer resistance, safety concerns, and delays or failures in expanding indications or approval pathways.

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References

[1] National Overactive Bladder Epidemiology Study. Journal of Urology, 2021.
[2] FDA Approval Letter for GEMTESA, 2020.