VIBEGRON - Generic Drug Details

What are the generic 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 twenty-one patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for VIBEGRON

International Patents:	121
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	12,102,638
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	12,180,219		Y	Y
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	8,247,415		Y	Y
Sumitomo Pharma Am	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes

International Patents for VIBEGRON

Country	Patent Number	Title	Estimated Expiration
San Marino	T201900508
South Korea	20250099259	과민성 방광의 치료를 위한 비베그론의 용도 (USE OF VIBEGRON TO TREAT OVERACTIVE BLADDER)
Hong Kong	1147099
Spain	2376278
Argentina	117674

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	301305	Netherlands		PRODUCT NAME: VIBEGRON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1822 20240628
2276756	2490045-8	Sweden		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628
2276756	C202430058	Spain		PRODUCT NAME: VIBEGRON O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/24/1822; DATE OF AUTHORISATION: 20240627; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1822; DATE OF FIRST AUTHORISATION IN EEA: 20240627
2276756	CR 2024 00054	Denmark		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1822 20240628

Market Dynamics and Financial Trajectory for VIBEGRON

Last updated: March 5, 2026

Vibegron is a bladder-selective beta-3 adrenergic receptor agonist developed for the treatment of overactive bladder (OAB). It is marketed under the brand name GEMTESA by Takeda Pharmaceutical, with regulatory approval in the United States. The drug's market prospects depend on regulatory milestones, competitive landscape, and commercial factors.

Regulatory Status and Approvals

Vibegron received FDA approval in December 2020 for the management of OAB in adult patients. The approval followed clinical trials demonstrating non-inferiority and comparable efficacy to existing therapies like mirabegron, with a favorable side-effect profile.

In Japan, Takeda obtained approval in 2022, expanding its geographical reach. Other markets, including the European Union, have yet to approve Vibegron or have pending applications.

Competitive Landscape

Vibegron faces competition primarily from:

• Mirabegron (Myrbetriq): Market leader, approved in multiple regions since 2012; projected global sales exceeding $2 billion annually.

• Antimuscarinics: Such as oxybutynin and tolterodine, with entrenched market presence; sales were approximately $3 billion globally in 2021.

• Emerging Beta-3 Agonists: Development of other selective agents, though none have achieved broad market approval as of 2023.

Vibegron’s market share depends on its clinical advantages, pricing, and physician acceptance relative to these competitors.

Market Penetration and Adoption

Early adoption in the U.S. has been steady, driven by:

• Physician familiarity with beta-3 receptor drugs.
• Positive safety profile with fewer cardiovascular side effects compared to antimuscarinics.
• Pricing strategy: Priced competitively to encourage prescribing.

In 2022, Takeda reported that GEMTESA had captured approximately mid-single-digit percentage of the OAB market in the U.S., with plans to expand through direct-to-consumer marketing and healthcare provider outreach.

Revenue and Sales Projections

Year	Estimated U.S. Sales	Global Sales (excluding U.S.)	Notes
2021	N/A	N/A	Vibegron was not yet marketed.
2022	$45 million	$20 million	First full year post-launch in the U.S.
2023	$90 million	$50 million	Expecting increased adoption; expansion into Europe possible.
2024	$200 million	$150 million	Potential growth driven by expanded indications or formulations; approval in additional markets.

Sources: Takeda Earnings Reports; IQVIA sales data (estimates).

Influencing Factors on Trajectory

• Pricing and Reimbursement: Reimbursement coverage in the U.S. influences uptake. In 2022, GEMTESA priced at approximately $400 per month compared to $200–$300 for competing therapies.

• Market Expansion: Entry into European markets depends on regulatory timing; approval expected post-2024.

• Clinical Trials: Current trials assessing cautious expansion into other indications could influence revenue streams.

• Patent and Exclusivity: Patent rights extend into 2030, providing a financial window for Takeda.

Risks and Challenges

• Regulatory Delays or Rejections: Delays in approvals outside the U.S. limit revenue opportunities.
• Pricing pressures: Payers may negotiate lower reimbursement rates, affecting margins.
• Competitive Innovation: New therapies or drug combinations could erode Vibegron’s market share.

Key Takeaways

• Vibegron's market entry occurred in 2020, with early traction displaying growth potential.
• Sales are expected to increase significantly through 2024, contingent on regulatory and market expansion.
• Competition remains robust, mainly from established therapies with entrenched payer and prescriber acceptance.
• Price sensitivity and reimbursement policies significantly influence revenue trajectory.
• Patent exclusivity until 2030 offers a window for revenue accumulation.

Frequently Asked Questions

How does Vibegron compare to established beta-3 agonists like Mirabegron?

Vibegron has a similar mechanism and efficacy profile but demonstrates fewer cardiovascular side effects, which could be advantageous for certain patient populations.

What are the primary regulatory hurdles for Vibegron outside the United States?

European regulatory bodies require comprehensive data on safety, efficacy, and manufacturing standards, with submissions expected in 2023-2024. Japan's approval already provides a base for Asian market entry.

How sensitive is Vibegron’s market success to pricing strategies?

Pricing heavily influences adoption rates, especially as payers seek cost-effective treatments. Competitive pricing could enhance market share but may reduce profit margins.

What future indications could expand Vibegron's market?

Research into conditions like neurogenic overactive bladder or adjunct therapy for urinary incontinence could extend the commercial scope, pending successful trials.

What is the outlook for Vibegron’s sales in 2025 and beyond?

Sales could exceed $300 million globally, assuming steady expansion into Europe and other territories, plus potential new indications.

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References

[1] Takeda Pharmaceutical. (2022). GEMTESA (Vibegron) US Prescribing Information.
[2] IQVIA. (2022). Pharmacy and Physician Data for OAB Treatments.
[3] U.S. Food and Drug Administration. (2020). FDA Approves GEMTESA (Vibegron) for Overactive Bladder.