Orange Book product · Brand (NDA)

JELMYTO

MITOMYCIN

Brand (NDA)NDA 211728RX UROGEN PHARMA

Apr 15, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 15, 2020
6 yr 3 mo ago
Today
Exclusivity ends · ODE-289
Orphan-drug exclusivity (7 years)
Apr 15, 2027
in 10 mo
Patent 12268745 expires
Listed method-of-use patent (U-4172) 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

PYELOCALYCEAL

TE code

Not listed

Application

NDA 211728

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
12268745	Jan 20, 2031	in 4 yr 8 mo	U-4172
9040074	Jan 20, 2031	in 4 yr 8 mo	Product
9950069	Jan 20, 2031	in 4 yr 8 mo	Product