Jelmyto is a drug owned by Urogen Pharma Ltd. It is protected by 2 US drug patents filed in 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 20, 2031. Details of Jelmyto's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9950069 | Material and method for treating internal cavities |
Jan, 2031
(6 years from now) | Active |
| US9040074 | Material and method for treating internal cavities |
Jan, 2031
(6 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 Jelmyto's patents.
Latest Legal Activities on Jelmyto's Patents
Given below is the list of recent legal activities going on the following patents of Jelmyto.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 17 Nov, 2022 | US9040074 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Oct, 2021 | US9950069 |
| Post Issue Communication - Certificate of Correction | 24 Jun, 2019 | US9040074 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 19 Nov, 2018 | US9040074 |
| Recordation of Patent Grant Mailed | 24 Apr, 2018 | US9950069 |
| Patent Issue Date Used in PTA Calculation | 24 Apr, 2018 | US9950069 |
| Email Notification | 05 Apr, 2018 | US9950069 |
| Issue Notification Mailed | 04 Apr, 2018 | US9950069 |
| Application Is Considered Ready for Issue | 19 Mar, 2018 | US9950069 |
| Dispatch to FDC | 19 Mar, 2018 | US9950069 |
FDA has granted several exclusivities to Jelmyto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jelmyto, 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 Jelmyto.
Exclusivity Information
Jelmyto holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Jelmyto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 15, 2023 |
| Orphan Drug Exclusivity(ODE-289) | Apr 15, 2027 |
US patents provide insights into the exclusivity only within the United States, but Jelmyto 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 Jelmyto's family patents as well as insights into ongoing legal events on those patents.
Jelmyto's family patents
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Generic Launch
Generic Release Date:
Jelmyto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 20, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jelmyto Generics:
Mitomycin is the generic name for the brand Jelmyto. 9 different companies have already filed for the generic of Jelmyto, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jelmyto's generic
About Jelmyto
Jelmyto is a drug owned by Urogen Pharma Ltd. Jelmyto uses Mitomycin as an active ingredient. Jelmyto was launched by Urogen Pharma in 2020.
Market Authorisation Date:
Jelmyto was approved by FDA for market use on 15 April, 2020.
Active Ingredient:
Jelmyto uses Mitomycin as the active ingredient. Check out other Drugs and Companies using Mitomycin ingredient
Dosage:
Jelmyto is available in powder form for pyelocalyceal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/VIAL | POWDER | Prescription | PYELOCALYCEAL |