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Mitomycin - Generic Drug Details

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Mitomycin is the generic ingredient in four branded drugs marketed by Hospira, Eurohlth Intl Sarl, Bristol Myers, Accord Hlthcare, Bristol, Supergen, and Mobius Therap, and is included in eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eight patent family members in five countries.

There are seven drug master file entries for mitomycin. Three suppliers are listed for this compound.

Summary for Generic Name: mitomycin

Tradenames:4
Patents:3
Applicants:7
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Bulk Api Vendors: see list52
Clinical Trials: see list68
Patent Applications: see list36,062
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mitomycin at DailyMed

Pharmacology for Ingredient: mitomycin

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
MITOMYCIN
mitomycin
INJECTABLE;INJECTION064144-001Apr 30, 1998RXYes► subscribe► subscribe
Bristol Myers
MUTAMYCIN
mitomycin
INJECTABLE;INJECTION062336-003Mar 10, 1988DISCNNo► subscribe► subscribe
Supergen
MITOZYTREX
mitomycin
INJECTABLE;INJECTION050763-001Nov 14, 2002DISCNNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: mitomycin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,539,241Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: mitomycin

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2008008802► subscribe
European Patent Office2046653► subscribe
Japan2014097399► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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