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SODIUM THIOSULFATE | N212937 | FENNEC PHARMACEUTICALS INC

1 strength7 unique patents1 unique exclusivity

Patent Timeline

7 unique patents (1 delisted), 1 exclusivity by expiration date

Active (7)TodayExclusivityIPRPTAB ChallengeDelisted

1 patent delisted from Orange Book — may indicate settlement, invalidation, or voluntary withdrawal

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Jan. 5, 2038DelistedIPR

ODE-384

Sep. 20, 2029

PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2022-00123	10596190	IPR	Hope Medical Enterprises, Inc.	Final Written Decision	2021-10-29	2023-04-18

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

96/000,390Ex ParteTerminated

Patent: 10596190Filed: 2022-01-11

METHOD FOR REDUCING OTOTOXICITY IN PEDIATRIC PATIENTS RECEIVING PLATINUM-BASED CHEMOTHERAPY

Recent Events

2022-01-21RXLITSRLitigation Search Conducted

2022-01-21RXRLFLitigation Found

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
FENNEC PHARMACEUTICALS, INC. v. CIPLA LIMITED et al 2:2025cv05709 3 patentsANDA 218028sodium thiosulfate	D.N.J.	2025-05-27	Terminated 2025-07-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSODIUM THIOSULFATE

DMF 355132020

CIPLA LTDSODIUM THIOSULFATE USP

DMF 362452021

INTAS PHARMACEUTICALS LTDSODIUM THIOSULFATE

DMF 367822022

LUITPOLD PHARMACEUTICALS INCInactiveSODIUM THIOSULFATE INJECTION, USP 25% ML VIAL

DMF 207152007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 21, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 12.5GM/100ML (125MG/ML)

RLD

7 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Sep 20, 2022

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10596190	Jan 5, 2038	—	—	—		Delisted
11291728	Jul 1, 2039	—	—	Yes	—	—
11510984	Jul 1, 2039	—	—	Yes	—	—
11617793	Jul 1, 2039	—	—	Yes	—	—
11964018	Jul 1, 2039	—	—	—		—
11992530	Jul 1, 2039	—	—	—		—
11998604	Jul 1, 2039	—	—	—		—

Exclusivities (1)

Code	Date	Status
ODE-384	Sep 20, 2029	Active