PEDMARK Drug Patent Profile
✉ Email this page to a colleague
When do Pedmark patents expire, and when can generic versions of Pedmark launch?
Pedmark is a drug marketed by Fennec Pharms Inc and is included in one NDA. There are seven patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-six patent family members in thirteen countries.
The generic ingredient in PEDMARK is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Pedmark
A generic version of PEDMARK was approved as sodium thiosulfate by HOPE PHARMS on February 14th, 2012.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for PEDMARK?
- What are the global sales for PEDMARK?
- What is Average Wholesale Price for PEDMARK?
Summary for PEDMARK
| International Patents: | 36 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 156 |
| Drug Prices: | Drug price information for PEDMARK |
| What excipients (inactive ingredients) are in PEDMARK? | PEDMARK excipients list |
| DailyMed Link: | PEDMARK at DailyMed |
Paragraph IV (Patent) Challenges for PEDMARK
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PEDMARK | Intravenous Injection | sodium thiosulfate | 12.5 g/100 mL | 212937 | 1 | 2022-10-18 |
| PEDMARK | Intravenous Injection | sodium thiosulfate | 12.5 g/100 mL | 212937 | 1 | 2022-10-07 |
US Patents and Regulatory Information for PEDMARK
PEDMARK is protected by seven US patents and two FDA Regulatory Exclusivities.
Patents protecting PEDMARK
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF REDUCING OTOTOXICITY IN A HUMAN PEDIATRIC PATIENT ABOUT 5 YEARS OF AGE OR UNDER WITH LOCALIZED MEDULLOBLASTOMA COMPRISING ADMINISTERING SODIUM THIOSULFATE ABOUT SIX HOURS AFTER ADMINISTRATION OF CISPLATIN
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Anhydrous sodium thiosulfate and formulations thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A PHARMACEUTICAL COMPOSITION OF ABOUT 0.5M SODIUM THIOSULFATE, ABOUT 0.004M BORIC ACID, AND A PH OF BETWEEN ABOUT 6.5 AND 8.9 FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR THE TREATMENT OF LOCALIZED CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A PHARMACEUTICAL COMPOSITION HAVING ABOUT 0.5M AQUEOUS ANHYDROUS SODIUM THIOSULFATE AND A CONCENTRATION OF BORATE IONS OF LESS THAN 0.05% FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR TREATMENT OF LOCALIZED CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF A PHARMACEUTICAL COMPOSITION HAVING A CONCENTRATION OF ABOUT 0.5M AQUEOUS ANHYDROUS SODIUM THIOSULFATE AND ABOUT 0.004M BORIC ACID FOR REDUCING OTOTOXICITY IN A PEDIATRIC PATIENT RECEIVING CISPLATIN FOR TREATMENT OF LOCALIZED CANCER
FDA Regulatory Exclusivity protecting PEDMARK
NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up
TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | 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 |
EU/EMA Drug Approvals for PEDMARK
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Fennec Pharmaceuticals (EU) Limited | Pedmarqsi | sodium thiosulfate | EMEA/H/C/005130 Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours. |
Authorised | no | no | no | 2023-05-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PEDMARK
See the table below for patents covering PEDMARK around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 279857 | נתרן תיוסולפט אל-מימי ותכשירים שלו (Anhydrous sodium thiosulfate and formulations thereof) | ⤷ Sign Up |
| Mexico | 2020013733 | TIOSULFATO DE SODIO ANHIDRO Y FORMULACIONES DE ESTE. (ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF.) | ⤷ Sign Up |
| Israel | 274645 | שיטה להפחתת אוטוטוקסיות בילדים חולים המקבלים כימותרפיה מבוסס פלטינום (Method for reducing ototoxicity in pediatric patients receiving platinum-based chemotherapy) | ⤷ Sign Up |
| South Korea | 20210027409 | 무수 싸이오황산나트륨 및 이의 제형 | ⤷ Sign Up |
| Mexico | 2020005572 | MÉTODO PARA REDUCIR OTOTOXICIDAD EN PACIENTES PEDIÁTRICOS QUE RECIBEN QUIMIOTERAPIA BASADA EN PLATINO. (METHOD FOR REDUCING OTOTOXICITY IN PEDIATRIC PATIENTS RECEIVING PLATINUM-BASED CHEMOTHERAPY.) | ⤷ Sign Up |
| Russian Federation | 2020122083 | СПОСОБ СНИЖЕНИЯ ОТОТОКСИЧНОСТИ У ПЕДИАТРИЧЕСКИХ ПАЦИЕНТОВ, ПОЛУЧАЮЩИХ ХИМИОТЕРАПИЮ ПРЕПАРАТАМИ ПЛАТИНЫ | ⤷ Sign Up |
| South Korea | 20210027410 | 무수 싸이오황산나트륨의 제형 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PEDMARK
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 1713823 | 92595 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1912999 | 2014/058 | Ireland | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1758590 | LUC00029 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 2822954 | 2018/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 2822954 | 18C1035 | France | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| 0290047 | 97C0108 | Belgium | ⤷ Sign Up | PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
