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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

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2029

2030

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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	NCED	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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Beta-Agonist Versus OnabotulinumtoxinA Trial for Urgency Urinary Incontinence NCT05806164	Phase 4	Active	Women and Infants Hospital of Rhode Island	432	2023-06-06 → 2030-08-01

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

Medicare Part D Spending

CMS annual spending data for Gemtesa (2023)

Total Spending

$508.5M

Total Claims

758,224

Beneficiaries

187,161

Avg Cost/Unit

$16.46

Spending Trend

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

YoY Change:+4.2%

5yr CAGR:+2.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs

6 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

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)

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