Details for New Drug Application (NDA): 212937
✉ Email this page to a colleague
NDA 212937 describes PEDMARK, which is a drug marketed by Fennec Pharms Inc and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the PEDMARK profile page.
The generic ingredient in PEDMARK is sodium thiosulfate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.
The generic ingredient in PEDMARK is sodium thiosulfate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.
Summary for 212937
| Tradename: | PEDMARK |
| Applicant: | Fennec Pharms Inc |
| Ingredient: | sodium thiosulfate |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212937
Generic Entry Date for 212937*:
Constraining patent/regulatory exclusivity:
TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 212937
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937 | NDA | Fennec Pharmaceuticals Inc. | 73077-010 | 73077-010-01 | 1 VIAL, SINGLE-DOSE in 1 BOX, UNIT-DOSE (73077-010-01) / 100 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 12.5GM/100ML (125MG/ML) | ||||
| Approval Date: | Sep 20, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS | ||||||||
| Patent: | 10,596,190 | Patent Expiration: | Jan 5, 2038 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| 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: | 11,291,728 | Patent Expiration: | Jul 1, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
