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Serving 500+ biopharmaceutical companies globally:

Colorcon
Teva
UBS
Mallinckrodt
Harvard Business School
Covington
Moodys
Healthtrust
Accenture
Boehringer Ingelheim

Generated: July 23, 2017

DrugPatentWatch Database Preview

Mitomycin - Generic Drug Details

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What are the generic drug sources for mitomycin and what is the scope of mitomycin freedom to operate?

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

Mitomycin has nine 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:4
Applicants:7
NDAs:8
Drug Master File Entries: see list7
Suppliers / Packagers: see list3
Bulk Api Vendors: see list52
Clinical Trials: see list175
Patent Applications: see list9,782
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mobius Therap
MITOSOL
mitomycin
FOR SOLUTION;TOPICAL022572-001Feb 7, 2012RXYesYes7,806,265► SubscribeY ► Subscribe
Accord Hlthcare
MITOMYCIN
mitomycin
INJECTABLE;INJECTION064144-001Apr 30, 1998APRXNoYes► Subscribe► Subscribe
Bristol Myers
MUTAMYCIN
mitomycin
INJECTABLE;INJECTION062336-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Bristol Myers
MUTAMYCIN
mitomycin
INJECTABLE;INJECTION062336-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Mobius Therap
MITOSOL
mitomycin
FOR SOLUTION;TOPICAL022572-001Feb 7, 2012RXYesYes8,186,511► SubscribeY ► 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
9,649,428Apparatus 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
Japan2009543608► Subscribe
Japan5448071► Subscribe
European Patent Office3175843► Subscribe
Japan5670546► Subscribe
Australia2007272514► 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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Serving 500+ biopharmaceutical companies globally:

McKinsey
Argus Health
Baxter
Cipla
Farmers Insurance
Fish and Richardson
AstraZeneca
Merck
Harvard Business School
Moodys

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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