PEDMARK Drug Patent Profile

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Which patents cover Pedmark, 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 14^th, 2012.

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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

Drug patent expirations by year for PEDMARK

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

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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

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Anhydrous sodium thiosulfate and formulations thereof
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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

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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

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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

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TO REDUCE THE RISK OF OTOTOXICITY ASSOCIATED WITH CISPLATIN IN PEDIATRIC PATIENTS 1 MONTH OF AGE AND OLDER WITH LOCALIZED, NON-METASTATIC SOLID TUMORS
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Glossary

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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
>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

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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.

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Country	Patent Number	Title	Estimated Expiration
Morocco	53101	THIOSULFATE DE SODIUM ANHYDRE ET FORMULATIONS DE CELUI-CI	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2019108592		⤷ Sign Up
European Patent Office	3817751	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2020009954		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PEDMARK

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	SPC/GB13/034	United Kingdom	⤷ Sign Up	PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
3141251	301099	Netherlands	⤷ Sign Up	PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016
2203431	15C0013	France	⤷ Sign Up	PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
2380576	2020/043	Ireland	⤷ Sign Up	PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description