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 twenty-two 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:	122
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	3
Patent Applications:	122
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
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 six 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
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			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			Y	Y
Sumitomo Pharma Am	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

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	2023071826	過活動膀胱を治療するためのビベグロンの使用
Israel	317220	שימוש בויבגרון לטפל בשלפוחית שתן עם פעילות יתר (Use of vibegron to treat overactive bladder)
Japan	7682605
European Patent Office	4545072	UTILISATION DE VIBEGRON POUR TRAITER DES SYMPTÔMES DE LA VESSIE HYPERACTIVE CHEZ LES HOMMES ATTEINTS D'HYPERPLASIE BÉNIGNE DE LA PROSTATE (USE OF VIBEGRON TO TREAT OVERACTIVE BLADDER SYMPTOMS IN MEN WITH BENIGN PROSTATIC HYPERPLASIA)
Netherlands	301305
Cyprus	1122690
Australia	2009231714

Supplementary Protection Certificates for GEMTESA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2276756	LUC00366	Luxembourg		PRODUCT NAME: VIBEGRON OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND 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	301305	Netherlands		PRODUCT NAME: VIBEGRON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1822 20240628
2276756	C20240046	Finland
2276756	24C1051	France		PRODUCT NAME: VIBEGRON OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION 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
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

Last updated: June 2, 2026

Gemtesa (vibegron) Market Dynamics and Financial Trajectory: Pricing, Volume, Competition, and Patent-Led Risk

Gemtesa (vibegron) has moved as a late-stage entrant into the overactive bladder (OAB) market with meaningful payer and prescriber adoption, while facing tightening competitive pressure from oral and combination OAB options, including mirabegron and antimuscarinic regimens. Financial trajectory is driven by (1) share shifts from older OAB therapies, (2) class-wide reimbursement dynamics for β3-agonists, and (3) how quickly competitors expand within managed care formularies. Patent and exclusivity timing determine the magnitude and timing of generic or biosimilar threats, which in turn shape long-range net sales expectations and valuation of the commercial franchise.

Because this request requires market sizing, revenue and segment growth, and patent-tied launch/erosion timing, and because no Gemtesa-specific financial and patent-lifecycle datasets were provided in the prompt, a complete and accurate financial trajectory assessment cannot be produced under the operating constraints.

If sufficient source inputs for Gemtesa net sales, growth rate by year/channel, forecast, and relevant FDA/Orange Book exclusivity and patent expiration dates were available, the analysis could be completed precisely.

What drives Gemtesa (vibegron) market dynamics in overactive bladder?

Featured snippet answer: Market dynamics for Gemtesa are driven by payer coverage for β3-agonists, formulary placement versus mirabegron, prescriber switching from antimuscarinics, and patient tolerability that reduces discontinuation.

Which segments and prescriber channels matter most for Gemtesa?

• Urology and women’s health (gynecology) clinics drive most OAB diagnosis and initial prescribing.
• Managed care formularies typically determine persistence and refill behavior more than gross brand awareness.

How does formulary access move Gemtesa volume?

Key mechanics in OAB class competition:

• Preferred status versus mirabegron and third-line antimuscarinic combinations.
• Step edits after failure of an antimuscarinic or generic β3-agonist comparator.
• Coverage tied to diagnosis coding (OAB-wet vs OAB-dry) and prior authorization criteria.

What patient tolerability factors influence adoption?

• β3-agonists are positioned as avoiding anticholinergic cognitive and dry-mouth adverse event burdens, improving continuation in mixed patient populations.
• Real-world persistence is a primary determinant of ROI after launch.

When does Gemtesa face generic entry risk and how does that shape financial trajectory?

Featured snippet answer: Generic entry risk depends on Orange Book-listed patents and exclusivities covering vibegron drug product, method-of-use, and manufacturing processes. That risk determines the magnitude and timing of price erosion and net sales decline.

What exclusivity timelines typically control the post-launch curve?

• Regulatory exclusivity (new chemical entity and/or other exclusivity categories, where applicable).
• Patent term (composition, formulation, process, and method-of-use patents).
• Patent litigation outcomes that can trigger design-around or early resolution.

How do Paragraph IV challenges affect expected net sales erosion?

• A successful Paragraph IV case can accelerate generic launch.
• Settlements can impose negotiated entry “carve-outs” or delayed launch.
• The strength and breadth of the patent estate determine likelihood of sustained exclusivity.

What patent landscape factors are most financially sensitive?

• Last-to-expire patent(s) and whether they cover the oral solid dosage form and/or dosing regimens.
• Whether competitors can avoid claims via alternative crystalline form, salt, or process.

How does Gemtesa pricing and reimbursement influence revenue growth versus peers?

Featured snippet answer: Gemtesa revenue performance depends on net price realization after rebates and formulary placement against mirabegron and antimuscarinic therapies.

What rebate and discount mechanisms change net sales?

• Contracting with PBMs affects effective net pricing.
• Patient assistance programs can improve volume but may compress net realizations.

How do OAB class dynamics affect payer behavior?

• As more β3-agonist coverage expands, payers reduce incentives for strict brand exclusivity.
• If competitors secure preferred formulary tiers, switching accelerates and net price pressure rises.

Which competitors most affect Gemtesa share and financial outcomes?

Featured snippet answer: Gemtesa competes primarily against oral β3-agonist mirabegron and antimuscarinic regimens, with second-order competition from combination therapies and intravesical options in refractory patients.

How does Gemtesa compare with mirabegron in adoption drivers?

• Both are β3-agonists, so differentiation tends to come from formulary positioning, prescriber familiarity, and payer tiering.
• Any “me-too” perception can lower switching rates unless reimbursement and access are favorable.

What antimuscarinic dynamics still matter in OAB?

• Antimuscarinics remain a large installed base due to long guideline familiarity and generic availability.
• Safety and tolerability can shift patients away from antimuscarinics, but price erosion of generics limits payer willingness to reimburse premium brands long term.

What is the Orange Book status of Gemtesa and what patents protect vibegron?

Featured snippet answer: Orange Book protection for Gemtesa includes listed patents tied to drug substance, drug product, and/or approved indications, and their expiration dates define generic risk windows.

Which patent types usually appear for OAB drugs like vibegron?

• Composition of matter (substance).
• Formulation (tablets, excipients, coating).
• Methods of treatment (OAB indications and endpoints).
• Manufacturing/process patents.

How do listing and expiration dates translate into launch modeling?

• “First eligible” launch date is driven by the earliest patent expiration plus any exclusivity carve-outs.
• Litigation can delay entry even when statutory exclusivity ends, based on court orders.

What patent litigation and settlements affect Gemtesa’s generic entry timeline?

Featured snippet answer: Court outcomes, stays, and settlement terms can shift generic launch by years versus purely statutory expectations.

What to look for in Gemtesa OAB patent litigation?

• Which patents were asserted and whether courts found infringement.
• Settlement terms: launch dates, design-around allowances, and contingent payments.

How does FDA regulatory status impact Gemtesa commercialization and future competition?

Featured snippet answer: FDA approvals determine the approved dosing and indication scope, which gates label-based switching and supports payer formulary strategies.

What FDA pathway specifics typically influence market uptake?

• Label breadth and whether Gemtesa fits payer criteria for step therapy.
• Differences in safety warnings that can influence formulary decisions for older populations.

Key Takeaways

• Gemtesa’s near-to-mid term financial trajectory is primarily a function of formulary access and class competition in OAB.
• Generic entry timing is determined by Orange Book patent and exclusivity structure plus litigation outcomes.
• The highest-risk variable for long-range net sales is the effective date of sustained generic erosion driven by the last-to-expire, broadest patent(s).

FAQs

1. How do PBM formulary tier changes typically impact vibegron (Gemtesa) net price and net sales?
2. What are the common patent estate components that delay generic entry for oral OAB drugs like Gemtesa?
3. How does step therapy design for OAB patients affect switching from mirabegron and antimuscarinics to vibegron?
4. What litigation outcomes most often lead to delayed generic launches in the β3-agonist market?
5. How do OAB subtype coverage rules (OAB-wet vs OAB-dry) change payer approval likelihood for Gemtesa?

References

1. Not provided in the prompt.

DrugChatter Q&A for GEMTESA

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