Is there a generic for Mitomycin?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Mitomycin, referencing the brand ZUSDURI. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Mitomycin?

ZUSDURI (NDA 215793, UROGEN PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Mitomycin?

The Orange Book lists 10 patents against Mitomycin products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Mitomycin have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Mitomycin. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Mitomycin are approved?

Mitomycin is approved in the following dosage forms: for solution, injectable, powder.

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 Jul 19, 2026Latest exclusivity ends Jun 12, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 19, 2026

3 mo ago

Brand (NDA) products

Originator applications

ZUSDURIRLDRS
UROGEN PHARMANDA 2157932025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/VIAL POWDER INTRAVESICAL Rx -
JELMYTORLDRS
UROGEN PHARMANDA 2117282020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/VIAL POWDER PYELOCALYCEAL Rx -
MITOSOLRLDRS
GLAUKOSNDA 0225722012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG/VIAL FOR SOLUTION TOPICAL Rx -
MITOZYTREXRLD
SUPERGENNDA 0507632002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5MG/VIAL INJECTABLE INJECTION Discontinued -
MUTAMYCINRLD
BRISTOLNDA 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 -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/VIAL	POWDER	INTRAVESICAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/VIAL	POWDER	PYELOCALYCEAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/VIAL	FOR SOLUTION	TOPICAL	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/VIAL	INJECTABLE	INJECTION	Discontinued	-

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

MITOMYCIN
FRESENIUS 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
MITOMYCIN
EUGIA 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 -
MITOMYCIN
GLANDANDA 2166482022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/VIAL INJECTABLE INJECTION Rx AP
MITOMYCIN
MEITHEALANDA 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
MITOMYCIN
MEITHEALANDA 2145042022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/VIAL INJECTABLE INJECTION Rx AP
MITOMYCIN
GLANDANDA 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
MITOMYCIN
RK 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
MITOMYCIN
RK PHARMAANDA 2033862017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40MG/VIAL INJECTABLE INJECTION Rx AP
MITOMYCIN
HIKMAANDA 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
MITOMYCINRS
ACCORD 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
MITOMYCIN
HOSPIRAANDA 0641061995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20MG/VIAL INJECTABLE INJECTION Discontinued -
MITOMYCIN
HIKMAANDA 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
MUTAMYCIN
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 -

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

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	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/VIAL	INJECTABLE	INJECTION	Rx	AP
20MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/VIAL	INJECTABLE	INJECTION	Rx	AP
20MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/VIAL	INJECTABLE	INJECTION	Rx	AP
20MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40MG/VIAL	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5MG/VIAL	INJECTABLE	INJECTION	Rx	AP
20MG/VIAL	INJECTABLE	INJECTION	Rx	AP

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20MG/VIAL	INJECTABLE	INJECTION	Discontinued	-

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

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

ODE-289Orphan-drug exclusivity (7 years)
Apr 15, 2027
in 6 mo
NPNew product exclusivity (3 years)
Jun 12, 2028
in 1 yr 8 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8186511	Jul 19, 2026	3 mo ago	Product
9205075	Jul 19, 2026	3 mo ago	Product
9539241	Jan 02, 2028	in 1 yr 3 mo	SubstanceProductU-2095
7806265	Feb 01, 2029	in 2 yr 4 mo	Product
9649428	May 21, 2029	in 2 yr 7 mo	U-2095
10039832	Jan 20, 2031	in 4 yr 4 mo	U-4256
9950069	Jan 20, 2031	in 4 yr 4 mo	ProductU-4256
9040074	Jan 20, 2031	in 4 yr 4 mo	ProductU-4256
12440568	Jan 20, 2031	in 4 yr 4 mo	U-4256
12268745	Jan 20, 2031	in 4 yr 4 mo	U-4172

Approval history

FDA approval span

First approval

Mar 10, 1988

39 yr 2 mo ago

Most recent approval

Jun 12, 2025

1 yr 5 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.

Ask AI about Mitomycin

Key facts

Active ingredient: Mitomycin
Brand (NDA): 5
Generic (ANDA): 13
Reference-listed drug: ZUSDURI
Dosage forms: FOR SOLUTION, INJECTABLE, POWDER
Routes: INJECTION, INTRAVESICAL, PYELOCALYCEAL, TOPICAL
TE codes: AP
Earliest patent expiry: Jul 19, 2026
Latest exclusivity: Jun 12, 2028

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