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. Twelve 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: | 89 |
| Clinical Trials: | 12 |
| Patent Applications: | 4,377 |
| 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 |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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Patent Expiration: ⤷ Sign Up
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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Patent Expiration: ⤷ Sign Up
Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
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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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mobius Therap | MITOSOL | mitomycin | FOR SOLUTION;TOPICAL | 022572-001 | Feb 7, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | 2014097399 | APPARATUS AND METHOD FOR RECONSTITUTING PHARMACEUTICAL AND PREPARING RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION | ⤷ Sign Up |
| Japan | 2009543608 | ⤷ Sign Up | |
| European Patent Office | 3175843 | APPAREIL ET PROCÉDÉ POUR RECONSTITUER UN PRODUIT PHARMACEUTIQUE ET PRÉPARER LE PRODUIT PHARMACEUTIQUE RECONSTITUÉ POUR UNE APPLICATION TRANSITOIRE (APPARATUS AND METHOD FOR RECONSTITUTING A PHARMACEUTICAL AND PREPARING THE RECONSTITUTED PHARMACEUTICAL FOR TRANSIENT APPLICATION) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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 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.
ISSN: 2162-2639
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