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MITOSOL

NDA

MITOMYCIN | N022572 | GLAUKOS CORP

1 strength5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Expiring < 1yr (2)Active (3)Today

2027

2028

2029

Today

Feb. 1, 2029

Jul. 19, 2026

Jul. 19, 2026

Jan. 2, 2028

May. 21, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

5 trials from ClinicalTrials.gov — 5 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Consolidative Therapy After EV + Pembrolizumab in Muscle Invasive Bladder Cancer, REINFORCE Trial NCT07579195	Phase 1/2	Not Yet Recruiting	University of Washington	12	2026-07-01 → 2029-12-31
Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC NCT07663747	Phase 2	Not Yet Recruiting	The Netherlands Cancer Institute	56	2026-09-01 → 2032-04-01
ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer NCT07425054	Phase 2	Recruiting	Jennifer Dorth	33	2026-06-19 → 2029-01
Enfortumab Vedotin in Combination With Pembrolizumab vs. Concurrent Chemoradiotherapy (cCRT) in People With Muscle Invasive Bladder Cancer (EV-309)NCT07566156	Phase 3	Recruiting	Astellas Pharma Global Development, Inc.	390	2026-05-11 → 2032-02-29
Combined Systemic and Intraperitoneal Chemotherapy for Synchronous Gastric and/or Gastroesophageal Peritoneal Carcinomatosis NCT07475286	Phase 2	Recruiting	Mohammad Haroon Asif Choudry	22	2026-06-12 → 2034-06-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain6 active DMFs3 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVMITOMYCIN

DMF 137911998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMITOMYCIN USP (ALTERNATIVE PROCESS)

DMF 256592011

CONCORD BIOTECH LTDMITOMYCIN USP

DMF 336622019

CHEMWERTH INCMITOMYCIN

DMF 338112019

WUXI FORTUNE PHARMACEUTICAL CO LTDMITOMYCIN

DMF 348662020

HUBEI HONCH PHARMACEUTICAL CO LTDMITOMYCIN

DMF 374622023

KYOWA HAKKO KOGYO CO LTDInactiveMITOMYCIN

DMF 135211998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMITOMYCIN USP

DMF 137831998

MICROBIOPHARM JAPAN CO LTDInactiveMITOMYCIN

DMF 137851998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 27, 2021	SUPPL -9	View Letter (PDF)
Dec 27, 2017	SUPPL -5	View Letter (PDF)
Jan 21, 2016	SUPPL -4	View Letter (PDF)
Sep 29, 2014	SUPPL -3	View Letter (PDF)
Feb 14, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2MG/VIAL

RLD

5 patents0 exclusivities▴

FOR SOLUTION;TOPICAL | Approved: Feb 7, 2012

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7806265	Feb 1, 2029	—	—	Yes	—	—
8186511	Jul 19, 2026	—	—	Yes	—	—
9205075	Jul 19, 2026	—	—	Yes	—	—
9539241	Jan 2, 2028	—	Yes	Yes		—
9649428	May 21, 2029	—	—	—		—