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Last Updated: September 25, 2022

MITOSOL Drug Patent Profile


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Which patents cover Mitosol, and what generic alternatives are available?

Mitosol is a drug marketed by Mobius Therap and is included in one NDA. There are five patents protecting this drug.

This drug has nine patent family members in five countries.

The generic ingredient in MITOSOL is mitomycin. There are seven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mitomycin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Mitosol

A generic version of MITOSOL was approved as mitomycin by HIKMA on April 19th, 1995.

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Summary for MITOSOL
International Patents:9
US Patents:5
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 84
Clinical Trials: 11
Patent Applications: 4,543
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in MITOSOL?MITOSOL excipients list
DailyMed Link:MITOSOL at DailyMed
Drug patent expirations by year for MITOSOL
Recent Clinical Trials for MITOSOL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ECOG-ACRIN Cancer Research GroupPhase 2
Mayo ClinicPhase 2
National Cancer Institute (NCI)Phase 2

See all MITOSOL clinical trials

US Patents and Regulatory Information for MITOSOL

MITOSOL is protected by five US patents.

Patents protecting MITOSOL

Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY

Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY

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;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mobius Therap MITOSOL mitomycin FOR SOLUTION;TOPICAL 022572-001 Feb 7, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for MITOSOL

See the table below for patents covering MITOSOL around the world.

Country Patent Number Title Estimated Expiration
Japan 2009543608 See Plans and Pricing
Japan 5670546 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2008008802 See Plans and Pricing
Japan 2014097399 APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION See Plans and Pricing
Japan 5448071 See Plans and Pricing
European Patent Office 2046653 DISPOSITIF ET PROCÉDÉ DE RECONSTITUTION D'UN PRODUIT PHARMACEUTIQUE ET PRÉPARATION DU PRODUIT PHARMACEUTIQUE EN VUE D'UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Express Scripts
Harvard Business School
Moodys
Dow

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 verification 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.