Viewing data from:

JELMYTO

NDA

MITOMYCIN | N211728 | UROGEN PHARMA LTD

1 strength3 unique patents1 unique exclusivity

Patent Timeline

3 unique patents, 1 exclusivity by expiration date

Active (3)TodayExclusivity

2027

2028

2029

2030

2031

Today

9040074

Jan. 20, 2031

9950069

Jan. 20, 2031

12268745

Jan. 20, 2031

ODE-289

Apr. 15, 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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
UroGen Pharma Ltd. et al v. Teva Pharmaceuticals, Inc. et al 1:2024cv00417 2 patentsANDA 218215mitomycin	D. Del.	2024-04-02	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Jelmyto (2023)

Total Spending

$38.1M

Total Claims

1,770

Beneficiaries

390

ASP Price

—

HCPCS: J9281 — Mitomycin pyelocalyceal instillation, 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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

4 letters from Drugs@FDA

Date	Submission	Document
Oct 7, 2024	SUPPL -10	View Letter (PDF)
May 15, 2024	SUPPL -3	View Letter (PDF)
Jan 19, 2021	SUPPL -1	View Letter (PDF)
Apr 16, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/VIAL

RLD

3 patents1 exclusivity▴

POWDER;PYELOCALYCEAL | Approved: Apr 15, 2020

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9040074	Jan 20, 2031	—	—	Yes	—	—
9950069	Jan 20, 2031	—	—	Yes	—	—
12268745	Jan 20, 2031	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-289	Apr 15, 2027	< 1 year