Vibegron - Generic Drug Details

What are the generic drug sources for vibegron and what is the scope of freedom to operate?

Vibegron is the generic ingredient in one branded drug marketed by Sumitomo Pharma Am and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vibegron has one hundred and nineteen patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for vibegron

International Patents:	119
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	13
What excipients (inactive ingredients) are in vibegron?	vibegron excipients list
DailyMed Link:	vibegron at DailyMed

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

Constraining patent/regulatory exclusivity:

8,653,260

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 vibegron

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	PHASE3
University of Alabama at Birmingham	NA
Urovant Sciences GmbH	Phase 2/Phase 3

See all vibegron clinical trials

Pharmacology for vibegron

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

Anatomical Therapeutic Chemical (ATC) Classes for vibegron

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

Paragraph IV (Patent) Challenges for VIBEGRON

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

US Patents and Regulatory Information for vibegron

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
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 vibegron

Country	Patent Number	Title	Estimated Expiration
El Salvador	2010003687	HIDROXIMETIL PIRROLIDINAS COMO AGONISTAS DEL RECEPTOR ADRENERGICO BETA 3
China	117695286
China	117695287

Supplementary Protection Certificates for vibegron

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2276756	49/2024	Austria		PRODUCT NAME: VIBEGRON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1822 (MITTEILUNG) 20240628
2276756	2490045-8	Sweden		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628
2276756	2024C/551	Belgium		PRODUCT NAME: VIBEGRON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1822 20240628

Market Dynamics and Financial Trajectory for VIBEGRON: A Strategic Overview

Last updated: September 3, 2025

Introduction

Vibegron, a novel selective β3-adrenergic receptor agonist, has emerged as a promising therapeutic agent, primarily targeting overactive bladder (OAB). Since its inception, the drug has been under meticulous evaluation for its market viability, competitive positioning, and growth prospects in the expanding urology therapeutics landscape. This report delineates the current market dynamics, prospective financial trajectory, and strategic considerations influencing Vibegron’s commercial success.

Pharmacological Profile and Clinical Development

Vibegron (Urouroguanetib) exemplifies a targeted approach in OAB management by modulating bladder muscle activity. Its selectivity for β3-adrenoceptors minimizes systemic side effects, a significant advantage over traditional antimuscarinics. Clinical trials have consistently demonstrated non-inferiority, with some evidence suggesting superior tolerability, positioning Vibegron as a promising alternative in its therapeutic class [1].

The drug received FDA approval in 2020 for the treatment of adult OAB, marking its entry into a competitive but expanding market. Regulatory milestones in other jurisdictions, such as the European Union and Japan, are underway, which could unlock additional growth avenues.

Market Dynamics

1. Market Size and Growth Potential

Overactive bladder affects approximately 33 million adults in the United States alone, with global prevalence exceeding 200 million [2]. The global OAB market is projected to grow at a CAGR of 8-10% over the next five years, driven by demographic trends, increased awareness, and broader acceptance of pharmacotherapy.

Vibegron's niche targeting and favorable safety profile position it well to capture a significant share, especially as physician preferences shift towards therapies with minimized adverse events. The market’s sizable base and growth trajectory underscore considerable commercial potential.

2. Competitive Landscape

Vibegron contends with established therapies, chiefly:

• Antimuscarinics (e.g., oxybutynin, solifenacin): oldest class, broad market but challenged by side effects like dry mouth and cognitive impairment.
• β3-adrenergic receptor agonists (e.g., Mirabegron): Vibegron’s primary competitor; Mirabegron leads the market with over $700 million in global sales in 2022 [3].

While Mirabegron has a first-mover advantage, Vibegron’s superior tolerability and efficacy data could carve out a meaningful segment, especially in patients intolerant to antimuscarinics.

3. Pricing and Reimbursement Strategies

Pricing strategies hinge on value demonstration—balancing affordability with premium positioning based on favorable safety profiles. Reimbursement coverage, especially under national health services and private insurers, will significantly influence uptake. Early negotiations and health technology assessments (HTAs) are pivotal to secure favorable formulary placements.

4. Regulatory and Patent Landscape

Patent exclusivity extends into the late 2020s, providing a temporary market monopoly. Further approvals and potential patent extensions can prolong market presence. However, off-patent competition and biosimilar entries, especially in generics markets, are potential long-term threats.

5. Market Penetration and Adoption

Physician acceptance hinges on demonstrated clinical efficacy, safety, and real-world evidence. Educational campaigns and clinician outreach will be essential to accelerate adoption, particularly given the conservative approach often associated with new pharmacotherapies in urology.

Financial Trajectory

1. Revenue Forecasting

Building on Mirabegron’s trajectory and Vibegron’s unique selling propositions, early market entry can be aligned with conservative initial sales estimates of $100-200 million in the first year post-launch in the U.S. The growth rate is anticipated to accelerate with expanded indications, geographic expansion, and increased physician acceptance.

Assuming a compound annual growth rate of approximately 15-20% over five years and a competitive intensity moderating with market maturation, Vibegron could reach annual sales surpassing the $500 million mark within five to seven years.

2. Cost Structure and Investment

Development costs, regulatory fees, marketing, and distribution expenses form the core expenditure components. Pharma companies like Urovant Sciences, which has developed Vibegron, typically allocate a significant portion towards post-marketing surveillance and educational initiatives. Operational efficiencies and strategic partnerships will influence profitability timelines.

3. Profitability Outlook

Profit margins depend on pricing strategies, market penetration, and cost management. Given the competitive environment, significant investment in marketing and physician education is anticipated. Breakeven could occur within 3-5 years, with profit margins improving as volumes increase and market share stabilizes.

4. Risks and Opportunities

Key risks include:

• Competitive responses from established players.
• Regulatory delays or unfavorable reimbursement decisions.
• Market resistance due to physician or patient preferences.

Conversely, opportunities arise from:

• Expansion into new indications, such as neurogenic bladder.
• Geographic expansion into Europe and Asia.
• Strategic alliances for distribution and co-marketing.

Strategic Considerations for Stakeholders

• Pharmaceutical firms should prioritize rapid market entry with robust educational initiatives.
• Investors must weigh early adoption risks against long-term growth potential.
• Healthcare providers benefit from understanding Vibegron’s safety profile to enhance patient adherence.
• Regulatory authorities influence valuation through approval timelines and reimbursement policies.

Conclusion: Market Outlook and Recommendations

Vibegron’s differentiating features and regulatory status position it as a competitive contender in the OAB therapeutic landscape. Its market dynamics will be driven by evolving clinician preferences, payor policies, and the ability to demonstrate value through real-world evidence. Financial forecasts suggest promising growth, contingent upon strategic execution and competitive responses.

For industry stakeholders, early engagement with regulators and payors, coupled with targeted educational campaigns, will expedite adoption. Long-term success hinges on expanding indications, global expansion, and sustaining a competitive edge through innovation and strategic collaborations.

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Key Takeaways

• Vibegron enters a sizeable and growing market, with significant upside potential in the global OAB therapeutics sector.
• Its favorable safety profile and targeted mechanism position it favorably against established therapies.
• Rapid market penetration, effective pricing, and reimbursement strategies are essential for maximizing financial returns.
• Competitive pressures necessitate continuous innovation and strategic expansion into new indications and markets.
• Early stakeholder engagement and robust evidence generation are pivotal for sustainable growth.

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FAQs

1. How does Vibegron differentiate itself from Mirabegron?
Vibegron offers a selective β3-adrenergic receptor agonist profile with a potentially improved safety and tolerability profile, especially concerning cardiovascular side effects, which can be advantageous in patient populations with comorbidities [1].

2. What is the current regulatory status of Vibegron globally?
Vibegron received FDA approval in 2020 for the treatment of adult OAB in the U.S. Regulatory reviews are ongoing or planned in the European Union, Japan, and other jurisdictions, with approval timelines dependent on local authorities’ evaluation processes.

3. What are the primary revenue drivers for Vibegron?
Initial revenues stem from U.S. sales post-approval, with subsequent growth driven by expanded indications, geographic expansion, and increased physician adoption. Long-term revenues will also depend on market share within the competitive landscape.

4. What are the main risks impacting Vibegron’s financial trajectory?
Risks include aggressive competition, regulatory hurdles, unfavorable reimbursement decisions, off-label competition, and potential safety concerns emerging post-market.

5. What strategic steps should companies consider for successful Vibegron commercialization?
Focus on early market penetration with comprehensive physician education, establishing strong payor relationships, expanding indications, and exploring international markets for sustained growth.

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References

1. Urovant Sciences. Vibegron (Urouroguanetib). Clinical Data Summary.
2. National Overactive Bladder (OAB) Association. Overactive Bladder Facts and Figures.
3. IQVIA. Pharmacy Market Data Reports, 2022.