Mitomycin Patent Expiration

Mitomycin was first introduced by Bristol Laboratories Inc Div Bristol Myers Co in its drug Mutamycin on Approved Prior to Jan 1, 1982. Other drugs containing Mitomycin are Mitosol, Mitozytrex, Zusduri, Jelmyto. 13 different companies have introduced drugs containing Mitomycin.


Mitomycin Patents

Given below is the list of patents protecting Mitomycin, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Jelmyto US12268745 Material and method for treating internal cavities Jan 20, 2031 Urogen Pharma
Jelmyto US9040074 Material and method for treating internal cavities Jan 20, 2031 Urogen Pharma
Jelmyto US9950069 Material and method for treating internal cavities Jan 20, 2031 Urogen Pharma
Zusduri US10039832 Material And Method For Treating Internal Cavities Jan 20, 2031 Urogen Pharma
Zusduri US12440568 Material And Method For Treating Internal Cavities Jan 20, 2031 Urogen Pharma
Zusduri US9040074 Material and method for treating internal cavities Jan 20, 2031 Urogen Pharma
Zusduri US9950069 Material and method for treating internal cavities Jan 20, 2031 Urogen Pharma
Mitosol US9649428 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application May 21, 2029 Glaukos
Mitosol US7806265 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Feb 01, 2029 Glaukos
Mitosol US9539241 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Jan 02, 2028 Glaukos
Mitosol US8186511 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Jul 19, 2026

(Expired)

Glaukos
Mitosol US9205075 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Jul 19, 2026

(Expired)

Glaukos



Mitomycin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Mitomycin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel National Cancer Institute (NCI) NA RECRUITING
(Sep 10, 2026)
PHASE2
A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer UroGen Pharma Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE3
Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive/-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study First Affiliated Hospital of Wenzhou Medical University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer Hamlet Pharma AB NA RECRUITING
(Sep 1, 2026)
PHASE3
Gemcitabine Versus Water Irrigation in Upper Tract Urothelial Carcinoma University of Texas Southwestern Medical Center NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE3
Disitamab Vedotin Plus Intravesical Mitomycin C in HER2-Expressing Intermediate- to High-Risk Non-Muscle-Invasive Bladder Cancer Shanxi Province Cancer Hospital NA RECRUITING
(Jun 1, 2026)
PHASE2
Enfortumab Vedotin + Pembrolizumab Induction to Spare the Bladder in MIBC The Netherlands Cancer Institute NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Therapeutic Instillation of Mistletoe Abnoba Gmbh NA TERMINATED
(May 1, 2026)
PHASE3
SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma Rutgers, The State University of New Jersey NA RECRUITING
(May 1, 2026)
PHASE2
Combination Nilotinib and Paclitaxel in Adults With Relapsed Solid Tumors National Cancer Institute (NCI) NA COMPLETED
(Apr 17, 2026)
PHASE1
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer UroGen Pharma Ltd. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE3
Flat Dose vs. Weight-based IP Chemotherapy for CRS/HIPEC Prakash Pandalai NA RECRUITING
(Mar 1, 2026)
PHASE2


Mitomycin Generic API Manufacturers

Several generic applications have been filed for Mitomycin. The first generic version for Mitomycin was by Bristol Myers Co and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Fresenius Kabi Usa Llc and was approved on Apr 5, 2024.

Given below is the list of companies who have filed for Mitomycin generic, along with the locations of their manufacturing plants worldwide.