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. Eleven 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.
Summary for MITOSOL
International Patents: | 9 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 89 |
Clinical Trials: | 12 |
Patent Applications: | 4,598 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in MITOSOL? | MITOSOL excipients list |
DailyMed Link: | MITOSOL at DailyMed |

Recent Clinical Trials for MITOSOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
City of Hope Medical Center | Phase 2 |
ECOG-ACRIN Cancer Research Group | Phase 2 |
Mayo Clinic | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for MITOSOL
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 | 5670546 | ⤷ Try a Trial | |
Japan | 2014097399 | APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Australia | 2007272514 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application | ⤷ Try a Trial |
Japan | 2009543608 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |