Viewing data from:

ZUSDURI

NDA

MITOMYCIN | N215793 | UROGEN PHARMA LTD

1 strength5 unique patents1 unique exclusivity

Patent Timeline

5 unique patents, 1 exclusivity by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

2044

2045

Today

Jan. 20, 2031

Jan. 20, 2031

Jan. 20, 2031

Jan. 20, 2031

Jul. 25, 2044

Jun. 12, 2028

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

200 trials from ClinicalTrials.gov — 18 recruiting, 12 active, 88 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer NCT03775265	Phase 3	Active	National Cancer Institute (NCI)	475	2019-06-03 → 2027-06-01
Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)NCT04241185	Phase 3	Active	Merck Sharp & Dohme LLC	520	2020-05-19 → 2031-11-01
A Study of TAR-200 Versus Intravesical Chemotherapy in Participants With Recurrent High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC) After Bacillus Calmette-Guérin (BCG)NCT06211764	Phase 3	Active	Janssen Research & Development, LLC	272	2024-04-09 → 2031-04-14
Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids NCT05024734	Phase 2	Active	Roland Seiler-Blarer	31	2023-02-21 → 2028-12-31
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
Bladder Preservation or Cystectomy for MIBC NCT07821177	Early Phase 1	Active	Dana-Farber Cancer Institute	20	2026-09-02 → 2029-09
Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. A Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group NCT04230759	Phase 2	Active	Goethe University	180	2020-01-07 → 2027-03-31
A Study of Chemotherapy and Radiation Therapy Compared to Chemotherapy and Radiation Therapy Plus MEDI4736 (Durvalumab) Immunotherapy for Bladder Cancer Which Has Spread to the Lymph Nodes, INSPIRE Trial NCT04216290	Phase 2	Active	National Cancer Institute (NCI)	11	2021-03-17 → 2027-05-19
Lower-Dose Chemoradiation in Treating Patients With Early-Stage Anal Cancer, the DECREASE Study NCT04166318	Phase 2	Active	ECOG-ACRIN Cancer Research Group	252	2020-01-02 → 2029-12-31
ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis NCT01815359	Phase 2	Active	Memorial Sloan Kettering Cancer Center	292	2013-03 → 2027-09

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$16422.11

Highest Price

$19447.24

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
72493-0106-03ZUSDURI KIT	$16422.11	Big4	Urogen Pharma, Inc.	12/31/2026
72493-0106-03ZUSDURI KIT	$19447.24	FSS	Urogen Pharma, Inc.	12/31/2026

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

API Supply Chain6 active DMFs3 inactive

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

TAPI NL BVMITOMYCIN

DMF 137911998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMITOMYCIN USP (ALTERNATIVE PROCESS)

DMF 256592011

CONCORD BIOTECH LTDMITOMYCIN USP

DMF 336622019

CHEMWERTH INCMITOMYCIN

DMF 338112019

WUXI FORTUNE PHARMACEUTICAL CO LTDMITOMYCIN

DMF 348662020

HUBEI HONCH PHARMACEUTICAL CO LTDMITOMYCIN

DMF 374622023

KYOWA HAKKO KOGYO CO LTDInactiveMITOMYCIN

DMF 135211998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMITOMYCIN USP

DMF 137831998

MICROBIOPHARM JAPAN CO LTDInactiveMITOMYCIN

DMF 137851998

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 13, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/VIAL

RLD

5 patents1 exclusivity▴

POWDER;INTRAVESICAL | Approved: Jun 12, 2025

Patents (5) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
9040074	Jan 20, 2031	—	—	Yes	—
9950069	Jan 20, 2031	—	—	Yes	—
10039832	Jan 20, 2031	—	—	—	—
12440568	Jan 20, 2031	—	—	—	—
12740940Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jul 25, 2044	—	—	—	—

Exclusivities (1)

Code	Date	Status
NP	Jun 12, 2028	Active