FDA Orange Book · active-ingredient family
Mitomycin
Mitomycin: 5 brands, 13 generics; first approved Mar 10, 1988; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 13 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
5
Generics (ANDA)
13
Listed patents
10
Next patent expiry
Jul 19, 2026
3 mo ago
Brand (NDA) products
Originator applications
- UROGEN PHARMANDA 2157932025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/VIAL POWDER INTRAVESICAL Rx — - UROGEN PHARMANDA 2117282020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/VIAL POWDER PYELOCALYCEAL Rx — - GLAUKOSNDA 0225722012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.2MG/VIAL FOR SOLUTION TOPICAL Rx — - MITOZYTREXRLDSUPERGENNDA 0507632002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Discontinued — - MUTAMYCINRLDBRISTOLNDA 050450—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (13)
Abbreviated applications
- MITOMYCINFRESENIUS KABI USAANDA 21126920243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP 40MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINEUGIA PHARMAANDA 21673220233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Discontinued — 40MG/VIAL INJECTABLE INJECTION Discontinued — - MITOMYCINGLANDANDA 2166482022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINMEITHEALANDA 21450520222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINMEITHEALANDA 2145042022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINGLANDANDA 21568720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINRK PHARMAANDA 20267020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINRK PHARMAANDA 2033862017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINHIKMAANDA 06418019992 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINRSACCORD HLTHCAREANDA 06414419983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Rx AP 20MG/VIAL INJECTABLE INJECTION Rx AP 40MG/VIAL INJECTABLE INJECTION Rx AP - MITOMYCINHOSPIRAANDA 0641061995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/VIAL INJECTABLE INJECTION Discontinued — - MITOMYCINHIKMAANDA 06411719953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Rx AP 40MG/VIAL INJECTABLE INJECTION Rx AP - BRISTOL MYERSANDA 062336—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/VIAL INJECTABLE INJECTION Discontinued — 20MG/VIAL INJECTABLE INJECTION Discontinued — 40MG/VIAL INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
in 1 yr 8 mo
- ODE-289Orphan-drug exclusivity (7 years)
in 6 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8186511 | 3 mo ago | Product | |
| 9205075 | 3 mo ago | Product | |
| 9539241 | in 1 yr 3 mo | SubstanceProductU-2095 | |
| 7806265 | in 2 yr 4 mo | Product | |
| 9649428 | in 2 yr 8 mo | U-2095 | |
| 10039832 | in 4 yr 4 mo | U-4256 | |
| 9950069 | in 4 yr 4 mo | ProductU-4256 | |
| 9040074 | in 4 yr 4 mo | ProductU-4256 | |
| 12440568 | in 4 yr 4 mo | U-4256 | |
| 12268745 | in 4 yr 4 mo | U-4172 |
Approval history
FDA approval span
First approval
39 yr 2 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 1988–2025 across 18 FDA applications.
Brand (NDA) 528%
Generic (ANDA) 1372%
Mitomycin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
