Pedmark Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11617793 Anhydrous sodium thiosulfate and formulations thereof
Jul, 2039

(14 years from now)

Active
US11964018 Therapeutic uses for sodium thiosulfate formulations
Jul, 2039

(14 years from now)

Active
US11992530 Therapeutic uses for sodium thiosulfate and 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
US10596190 Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy
Jan, 2038

(13 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.

Given below is the list of recent legal activities going on the following patents of Pedmark.

Activity Date Patent Number
Patent litigations
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 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 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.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US10596190 October, 2021 Final Written Decision
(18 Apr, 2023)
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

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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

Pedmark has patent protection in a total of 13 countries. It's US patent count contributes only to 35.3% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Pedmark.

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

Alternative Brands for Pedmark

Pedmark which is used for reducing ototoxicity in pediatric patients with localized medulloblastoma following cisplatin administration., has several other brand drugs using the same active ingredient (Sodium Thiosulfate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Hope Pharms
Nithiodote
Sodium Thiosulfate






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.

Approval 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