FDA Orange Book · active-ingredient family
Mitomycin
Mitomycin is approved as 5 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZUSDURI · NDA 215793
5
Brand (NDA)
13
Generics (ANDA)
10
Listed patents
2
Exclusivity periods
Brand (NDA) products · for solution, injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZUSDURIRLD | UROGEN PHARMA | NDA 215793 | — | Jun 12, 2025 | |
| JELMYTORLD | UROGEN PHARMA | NDA 211728 | — | Apr 15, 2020 | |
| MITOSOLRLD | GLAUKOS | NDA 022572 | — | Feb 07, 2012 | |
| MITOZYTREXRLD | SUPERGEN | NDA 050763 | — | Nov 14, 2002 | |
| MUTAMYCINRLD×2 | BRISTOL | NDA 050450 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MITOMYCIN×3 | FRESENIUS KABI USA | ANDA 211269 | AP | Apr 05, 2024 | |
| MITOMYCIN×3 | EUGIA PHARMA | ANDA 216732 | — | Oct 30, 2023 | |
| MITOMYCIN | GLAND | ANDA 216648 | AP | Nov 22, 2022 | |
| MITOMYCIN×2 | MEITHEAL | ANDA 214505 | AP | Sep 08, 2022 | |
| MITOMYCIN | MEITHEAL | ANDA 214504 | AP | Sep 06, 2022 | |
| MITOMYCIN×2 | GLAND | ANDA 215687 | AP | Oct 20, 2021 | |
| MITOMYCIN×2 | RK PHARMA | ANDA 202670 | AP | Oct 13, 2017 | |
| MITOMYCIN | RK PHARMA | ANDA 203386 | AP | Oct 13, 2017 | |
| MITOMYCIN×2 | HIKMA | ANDA 064180 | AP | Dec 23, 1999 | |
| MITOMYCIN×3 | ACCORD HLTHCARE | ANDA 064144 | AP | Apr 30, 1998 | |
| MITOMYCIN | HOSPIRA | ANDA 064106 | — | Nov 29, 1995 | |
| MITOMYCIN×3 | HIKMA | ANDA 064117 | — | Apr 19, 1995 | |
| MUTAMYCIN×3 | BRISTOL MYERS | ANDA 062336 | — | Approved Prior to Jan 1, 1982 |
Marketing exclusivity (2)
- NPNew product exclusivity (3 years)
Jun 12, 2028
in 2 yr
- ODE-289Orphan-drug exclusivity (7 years)
Apr 15, 2027
in 10 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8186511 | Jul 19, 2026 | in 1 mo | Product |
| 9205075 | Jul 19, 2026 | in 1 mo | Product |
| 9539241 | Jan 02, 2028 | in 1 yr 7 mo | SubstanceProductU-2095 |
| 7806265 | Feb 01, 2029 | in 2 yr 8 mo | Product |
| 9649428 | May 21, 2029 | in 3 yr | U-2095 |
| 10039832 | Jan 20, 2031 | in 4 yr 8 mo | U-4256 |
| 9950069 | Jan 20, 2031 | in 4 yr 8 mo | ProductU-4256 |
| 9040074 | Jan 20, 2031 | in 4 yr 8 mo | ProductU-4256 |
| 12440568 | Jan 20, 2031 | in 4 yr 8 mo | U-4256 |
| 12268745 | Jan 20, 2031 | in 4 yr 8 mo | U-4172 |
Mitomycin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
