Mitosol is a drug owned by Mobius Therapeutics Llc. It is protected by 5 US drug patents filed from 2013 to 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 21, 2029. Details of Mitosol's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US9539241 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
Jan, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8186511 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
Jul, 2026
(1 year, 11 months from now) | Active |
| US9205075 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
Jul, 2026
(1 year, 11 months from now) | Active |
| US7806265 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
Feb, 2029
(4 years from now) | Active |
| US9649428 | Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application |
May, 2029
(4 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Mitosol's patents.
Latest Legal Activities on Mitosol's Patents
Given below is the list of recent legal activities going on the following patents of Mitosol.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 10 Jul, 2024 | US9539241 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 23 Oct, 2023 | US8186511 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 08 Jun, 2023 | US9205075 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 05 Apr, 2022 | US7806265 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 16 Nov, 2020 | US9649428 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 10 Jul, 2020 | US9539241 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 23 Oct, 2019 | US8186511 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 10 Jun, 2019 | US9205075 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 05 Apr, 2018 | US7806265 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 30 Mar, 2018 | US9205075 |
FDA has granted several exclusivities to Mitosol. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Mitosol, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Mitosol.
Exclusivity Information
Mitosol holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Mitosol's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-21) | Feb 07, 2019 |
| Orphan Drug Exclusivity(ODE) | Feb 07, 2019 |
US patents provide insights into the exclusivity only within the United States, but Mitosol is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Mitosol's family patents as well as insights into ongoing legal events on those patents.
Mitosol's family patents
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Generic Launch
Generic Release Date:
Mitosol's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 21, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Mitosol Generics:
Mitomycin is the generic name for the brand Mitosol. 9 different companies have already filed for the generic of Mitosol, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Mitosol's generic
About Mitosol
Mitosol is a drug owned by Mobius Therapeutics Llc. It is used for reducing scarring and improving surgical outcomes in glaucoma filtration surgery. Mitosol uses Mitomycin as an active ingredient. Mitosol was launched by Mobius Therap in 2012.
Can you believe Mitosol received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Mitosol was approved by FDA for market use on 07 February, 2012.
Active Ingredient:
Mitosol uses Mitomycin as the active ingredient. Check out other Drugs and Companies using Mitomycin ingredient
Treatment:
Mitosol is used for reducing scarring and improving surgical outcomes in glaucoma filtration surgery.
Dosage:
Mitosol is available in for solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2MG/VIAL | FOR SOLUTION | Prescription | TOPICAL |