Viewing data from:

GEMTESA

NDA

VIBEGRON | N213006 | SUMITOMO PHARMA AMERICA INC

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

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2033

2034

2035

2036

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2043

Today

Dec. 23, 2034

Apr. 2, 2029

Mar. 22, 2040

Mar. 12, 2034

Jul. 6, 2042

I-955

Dec. 18, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

5 cases on OB patents (4 active) from PACER

Case	Court	Filed	Status	Judge
Urovant Sciences GmbH et al v. Annora Pharma Private Limited et al 1:2025cv00419 1 patentANDA 220207vibegron	D. Del.	2025-04-03	Active	—
Urovant Sciences GmbH et al v. MSN Laboratories Private Limited et al 1:2025cv00420 1 patentANDA 220285vibegron	D. Del.	2025-04-03	Active	—
Urovant Sciences GmbH et al v. Intas Pharmaceuticals Limited et al 5:2025cv00163 1 patentANDA 220254vibegron	E.D.N.C.	2025-03-27	Terminated 2025-06-12	—
Urovant Sciences GmbH et al v. Apotex Inc. et al 1:2025cv00372 1 patentANDA 220169vibegron	D. Del.	2025-03-26	Active	—
Urovant Sciences GmbH et al v. Accord Healthcare Inc., 1:2025cv00373 1 patentANDA 220254Vibegron	D. Del.	2025-03-26	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Single Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Participants With Renal Insufficiency (MK-4618-014)NCT01628042	Phase 1	Completed	Merck Sharp & Dohme LLC	32	2012-07-16 → 2013-01-25
A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)NCT03492281	Phase 3	Completed	Urovant Sciences GmbH	1,530	2018-03-26 → 2019-02-04
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome NCT03806127	Phase 2	Completed	Urovant Sciences GmbH	222	2018-12-31 → 2020-10-06
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)NCT01737684	Phase 1	Completed	Merck Sharp & Dohme LLC	16	2013-01-15 → 2013-06-14
Study to Evaluate the Efficacy, Safety and Tolerability of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia (BPH)NCT03902080	Phase 3	Completed	Urovant Sciences GmbH	1,105	2019-03-26 → 2023-06-15
A Study of the Efficacy and Safety of Vibegron (MK-4618) in Participants With Overactive Bladder (OAB) (MK-4618-008)NCT01314872	Phase 2	Completed	Merck Sharp & Dohme LLC	1,395	2011-03-31 → 2013-10-10
An Extension Study to Examine the Safety and Tolerability of a New Drug in Patients With Symptoms of Overactive Bladder (OAB).NCT03583372	Phase 3	Completed	Urovant Sciences GmbH	506	2018-06-14 → 2019-07-25
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia NCT04103450	Phase 3	Completed	Urovant Sciences GmbH	276	2019-09-19 → 2022-07-29
A Study of the Pharmacokinetics and Pharmacodynamics of Vibegron (MK-4618) in Women With Overactive Bladder (MK-4618-004)NCT01500382	Phase 1	Terminated	Merck Sharp & Dohme LLC	4	2012-02-27 → 2013-01-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$16.46

per ea

Lowest NADAC/Unit

$16.46

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
73336007530GEMTESA 75 MG TABLET	$16.46	EA	Brand	—	2026-06-17
73336007590GEMTESA 75 MG TABLET	$16.46	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$369.22

Highest Price

$1231.68

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73336-0075-30GEMTESA 75MG TAB	$450.62	FSS	Sumitomo Pharma America, Inc.	07/31/2026
73336-0075-30GEMTESA 75MG TAB	$369.22	Big4	Sumitomo Pharma America, Inc.	07/31/2026
73336-0075-90GEMTESA 75MG TAB	$1231.68	FSS	Sumitomo Pharma America, Inc.	07/31/2026
73336-0075-90GEMTESA 75MG TAB	$1102.76	Big4	Sumitomo Pharma America, Inc.	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Gemtesa (2024)

Total Spending

$945.1M

Total Claims

1,361,795

Beneficiaries

320,270

Avg Cost/Unit

$15.88

Spending Trend

$28.4M(2021)→$164.5M(2022)→$508.5M(2023)→$945.1M(2024)

YoY Change:-3.5%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain8 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

AMI LIFESCIENCES PRIVATE LTDVIBEGRON

DMF 395382024

YANGZHOU AURISCO PHARMACEUTICAL CO LTDVIBEGRON

DMF 400682024

PORTON PHARMA SOLUTIONS LTDVIBEGRON

DMF 402752024

MSN ORGANICS PRIVATE LTDVIBEGRON

DMF 403042024

HONOUR LAB LTDVIBEGRON

DMF 403332024

CHANGZHOU PHARMACEUTICAL FACTORYVIBEGRON

DMF 432972025

LEE PHARMA LTDVIBEGRON

DMF 434492026

ALIVUS LIFE SCIENCES LTDVIBEGRON

DMF 439342026

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 19, 2024	SUPPL -13	View Letter (PDF)
Dec 19, 2024	SUPPL -11	View Letter (PDF)
Dec 28, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 75MG

RLD

5 patents1 exclusivity▴

TABLET;ORAL | Approved: Dec 23, 2020

Patents (5) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8247415	Dec 23, 2034	—	Yes	Yes		—
8653260	Apr 2, 2029	—	Yes	—	—	—
12102638	Mar 22, 2040	—	—	—		—
12180219	Mar 12, 2034	—	Yes	Yes	—	—
12357636	Jul 6, 2042	—	—	—		—

Exclusivities (1)

Code	Date	Status
I-955	Dec 18, 2027	Active