Orange Book product · Brand (NDA)

ZUSDURI

MITOMYCIN

Brand (NDA)NDA 215793RX UROGEN PHARMA

Jun 12, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 12, 2025
1 yr ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Jun 12, 2028
in 2 yr
Patent 10039832 expires
Listed method-of-use patent (U-4256) expiration.
Jan 20, 2031
in 4 yr 8 mo
Patent 12440568 expires
Listed method-of-use patent (U-4256) expiration.
Jan 20, 2031
in 4 yr 8 mo
Patent 9040074 expires
Listed drug product patent expiration.
Jan 20, 2031
in 4 yr 8 mo
Patent 9950069 expires
Listed drug product patent expiration.
Jan 20, 2031
in 4 yr 8 mo

Active ingredient

MITOMYCIN

Strength

40MG/VIAL

Dosage form

POWDER

Route

INTRAVESICAL

TE code

Not listed

Application

NDA 215793

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10039832	Jan 20, 2031	in 4 yr 8 mo	U-4256
12440568	Jan 20, 2031	in 4 yr 8 mo	U-4256
9040074	Jan 20, 2031	in 4 yr 8 mo	ProductU-4256
9950069	Jan 20, 2031	in 4 yr 8 mo	ProductU-4256