Orange Book product · Brand (NDA)

MITOSOL

MITOMYCIN

Brand (NDA)NDA 022572RX GLAUKOS

Feb 07, 2012

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 07, 2012
14 yr 7 mo ago
Today
Patent 8186511 expires
Listed drug product patent expiration.
Jul 19, 2026
in 1 mo
Patent 9205075 expires
Listed drug product patent expiration.
Jul 19, 2026
in 1 mo
Patent 9539241 expires
Listed drug substance patent expiration.
Jan 02, 2028
in 1 yr 7 mo
Patent 7806265 expires
Listed drug product patent expiration.
Feb 01, 2029
in 2 yr 8 mo
Patent 9649428 expires
Listed method-of-use patent (U-2095) expiration.
May 21, 2029
in 3 yr

Active ingredient

MITOMYCIN

Strength

0.2MG/VIAL

Dosage form

FOR SOLUTION

Route

TOPICAL

TE code

Not listed

Application

NDA 022572

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
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