Pedmark is a drug owned by Fennec Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 01, 2039. Details of Pedmark'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). | |||
| US10596190 | Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy |
Jan, 2038
(13 years from now) | Active |
| US11992530 | Therapeutic uses for sodium thiosulfate and formulations |
Jul, 2039
(14 years from now) | Active |
| US11964018 | Therapeutic uses for sodium thiosulfate formulations |
Jul, 2039
(14 years from now) | Active |
| US11998604 | Therapeutic uses for sodium thiosulfate formulations |
Jul, 2039
(14 years from now) | Active |
| US11510984 | Anhydrous sodium thiosulfate and formulations thereof |
Jul, 2039
(14 years from now) | Active |
| US11291728 | Anhydrous sodium thiosulfate and formulations thereof |
Jul, 2039
(14 years from now) | Active |
| US11617793 | Anhydrous sodium thiosulfate and formulations thereof |
Jul, 2039
(14 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 Pedmark's patents.
Latest Legal Activities on Pedmark's Patents
Given below is the list of recent legal activities going on the following patents of Pedmark.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent eCofC Notification | 16 Jul, 2024 | US11617793 |
| Email Notification | 16 Jul, 2024 | US11617793 |
| Recordation of Patent eCertificate of Correction | 16 Jul, 2024 | US11617793 |
| Mail Patent eCofC Notification | 16 Jul, 2024 | US11617793 |
| Mail Certificate of Correction Memo | 30 May, 2024 | US11291728 |
| Certificate of Correction Memo | 29 May, 2024 | US11291728 |
| Patent eGrant Notification | 23 Apr, 2024 | US11964018 |
| Email Notification | 23 Apr, 2024 | US11964018 |
| Mail Patent eGrant Notification | 23 Apr, 2024 | US11964018 |
| Patent Issue Date Used in PTA Calculation | 23 Apr, 2024 | US11964018 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Pedmark and ongoing litigations to help you estimate the early arrival of Pedmark generic.
Pedmark's Litigations
Pedmark has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 29, 2021, against patent number US10596190. The petitioner Hope Medical Enterprises, Inc., challenged the validity or infringement of this patent, with Oregon Health & Science University et al. as the respondent. Click below to track the latest information on how companies are challenging Pedmark's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10596190 | October, 2021 | Final Written Decision | Oregon Health & Science University et al. | Hope Medical Enterprises, Inc. |
FDA has granted some exclusivities to Pedmark. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Pedmark, 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 Pedmark.
Exclusivity Information
Pedmark holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Pedmark's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 20, 2025 |
| Orphan Drug Exclusivity(ODE-384) | Sep 20, 2029 |
US patents provide insights into the exclusivity only within the United States, but Pedmark 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 Pedmark's family patents as well as insights into ongoing legal events on those patents.
Pedmark's family patents
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Generic Launch
Generic Release Date:
Pedmark's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 01, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Pedmark Generics:
There are no approved generic versions for Pedmark as of now.
How can I launch a generic of Pedmark before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Pedmark's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Pedmark's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Pedmark -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 g/100 mL | 07 Oct, 2022 | 1 | 01 Jul, 2039 |
About Pedmark
Pedmark is a drug owned by Fennec Pharmaceuticals Inc. It is used for reducing ototoxicity in pediatric patients with localized medulloblastoma following cisplatin administration. Pedmark uses Sodium Thiosulfate as an active ingredient. Pedmark was launched by Fennec Pharms Inc in 2022.
Market Authorisation Date:
Pedmark was approved by FDA for market use on 20 September, 2022.
Active Ingredient:
Pedmark uses Sodium Thiosulfate as the active ingredient. Check out other Drugs and Companies using Sodium Thiosulfate ingredient
Treatment:
Pedmark is used for reducing ototoxicity in pediatric patients with localized medulloblastoma following cisplatin administration.
Dosage:
Pedmark is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 12.5GM/100ML (125MG/ML) | SOLUTION | Prescription | INTRAVENOUS |