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Serving leading biopharmaceutical companies globally:

Healthtrust
Deloitte
QuintilesIMS
Chinese Patent Office
Dow
Daiichi Sankyo
US Army
Moodys
Queensland Health
Argus Health

Generated: December 13, 2017

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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 Mobius Therap, Accord Hlthcare, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Supergen, Bristol, and Bristol Myers, and is included in ten NDAs. There are five 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.

Pharmacology for MITOMYCIN

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
BristolMUTAMYCINmitomycinINJECTABLE;INJECTION050450-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Accord HlthcareMITOMYCINmitomycinINJECTABLE;INJECTION064144-001Apr 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Mobius TherapMITOSOLmitomycinFOR SOLUTION;TOPICAL022572-001Feb 7, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdMITOMYCINmitomycinINJECTABLE;INJECTION202670-002Oct 13, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdMITOMYCINmitomycinINJECTABLE;INJECTION203386-001Oct 13, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
West-ward Pharms IntMITOMYCINmitomycinINJECTABLE;INJECTION064180-001Dec 23, 1999APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bristol MyersMUTAMYCINmitomycinINJECTABLE;INJECTION062336-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mobius TherapMITOSOLmitomycinFOR SOLUTION;TOPICAL022572-001Feb 7, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Mobius TherapMITOSOLmitomycinFOR SOLUTION;TOPICAL022572-001Feb 7, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Accord HlthcareMITOMYCINmitomycinINJECTABLE;INJECTION064144-003Aug 11, 2009APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: mitomycin

Country Document Number Estimated Expiration
European Patent Office2046653► Subscribe
Japan5670546► Subscribe
World Intellectual Property Organization (WIPO)2008008802► Subscribe
Japan2009543608► Subscribe
Japan2014097399► Subscribe
European Patent Office3175843► Subscribe
Canada2659314► Subscribe
Australia2007272514► Subscribe
Japan5448071► 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 leading biopharmaceutical companies globally:

Cerilliant
McKesson
Express Scripts
Fuji
US Department of Justice
Harvard Business School
McKinsey
Fish and Richardson
Covington
Merck

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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