mitomycin

It is formulated by 7 pharmaceutical companies such as MOBIUS THERAP, RK PHARMA, UROGEN PHARMA and others. It is marketed under 4 brand names, including MITOSOL, MITOMYCIN, JELMYTO and others. Available in 4 different strengths, such as 0.2MG/VIAL, 5MG/VIAL, 40MG/VIAL and others, and administered through 4 routes including FOR SOLUTION;TOPICAL, INJECTABLE;INJECTION, POWDER;PYELOCALYCEAL and others.

Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

Strategic Dashboard

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Sourcing & Feasibility

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groups Licensing: 7 potential partners

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timeline Key Patent Barrier & Expiry Timeline

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factoryGeneric Manufacturer Snapshot

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Legal Status

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Expiry From

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Expiry To

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength	Route of Administration	Companies	Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

	Patent Number	Publication Date	Legal Status	Patent Expiry Date
{"application_id":"57420","ingredient":"MITOMYCIN","trade_name":"MITOSOL","family_id":"59de53d52a9c490bb9f1","publication_number":"US8186511B2","cleaned_patent_number":"8186511","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-19","publication_date":"2012-05-29","legal_status":"Granted"}	US8186511B2 Formulation	29 May, 2012	Granted	19 Jul, 2026
{"application_id":"57421","ingredient":"MITOMYCIN","trade_name":"MITOSOL","family_id":"59de53d52a9c490bb9f1","publication_number":"US9205075B2","cleaned_patent_number":"9205075","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-19","publication_date":"2015-12-08","legal_status":"Granted"}	US9205075B2 Formulation	08 Dec, 2015	Granted	19 Jul, 2026
{"application_id":"57422","ingredient":"MITOMYCIN","trade_name":"MITOSOL","family_id":"59de53d52a9c490bb9f1","publication_number":"US9539241B2","cleaned_patent_number":"9539241","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-02","publication_date":"2017-01-10","legal_status":"Patented case"}	US9539241B2 Molecular Formulation	10 Jan, 2017	Patented case	02 Jan, 2028
{"application_id":"57419","ingredient":"MITOMYCIN","trade_name":"MITOSOL","family_id":"59de53d52a9c490bb9f1","publication_number":"US7806265B2","cleaned_patent_number":"7806265","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-01","publication_date":"2010-10-05","legal_status":"Patented case"}	US7806265B2 Formulation	05 Oct, 2010	Patented case	01 Feb, 2029
{"application_id":"57412","ingredient":"MITOMYCIN","trade_name":"MITOSOL","family_id":"59de53d52a9c490bb9f1","publication_number":"US9649428B2","cleaned_patent_number":"9649428","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-21","publication_date":"2017-05-16","legal_status":"Patented case"}	US9649428B2	16 May, 2017	Patented case	21 May, 2029
{"application_id":"69559","ingredient":"MITOMYCIN","trade_name":"JELMYTO","family_id":"3a3e3e5ed5d34b099dc9","publication_number":"US9950069B2","cleaned_patent_number":"9950069","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-20","publication_date":"2018-04-24","legal_status":"Patented case"}	US9950069B2 Formulation	24 Apr, 2018	Patented case	20 Jan, 2031
{"application_id":"69551","ingredient":"MITOMYCIN","trade_name":"JELMYTO","family_id":"3a3e3e5ed5d34b099dc9","publication_number":"US9040074B2","cleaned_patent_number":"9040074","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-20","publication_date":"2015-05-26","legal_status":"Granted"}	US9040074B2 Formulation	26 May, 2015	Granted	20 Jan, 2031
{"application_id":"164427","ingredient":"MITOMYCIN","trade_name":"JELMYTO","family_id":"","publication_number":"US12268745B2","cleaned_patent_number":"12268745","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-20","publication_date":"2025-04-08","legal_status":"Granted"}	US12268745B2	08 Apr, 2025	Granted	20 Jan, 2031

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID	Title	Status	Phase	Conditions	Start Date	Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

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ACCORD HLTHCARE Total Dosages: 3

BRISTOL MYERS Total Dosages: 3 Manufacturing Locations: 4

EUGIA PHARMA Total Dosages: 3 Manufacturing Locations: 3

FRESENIUS KABI USA Total Dosages: 3 Manufacturing Locations: 8

GLAND Total Dosages: 3 Manufacturing Locations: 29

HIKMA Total Dosages: 5 Manufacturing Locations: 6

HOSPIRA Total Dosages: 1 Manufacturing Locations: 8

MEITHEAL Total Dosages: 3

RK PHARMA Total Dosages: 3 Manufacturing Locations: 16

Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.