PEDMARK Drug Patent Profile

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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 five patents protecting this drug and one Paragraph IV challenge.

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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	156
Formulation / Manufacturing:	see details
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	2022-10-07

US Patents and Regulatory Information for PEDMARK

PEDMARK is protected by five 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

FDA Regulatory Exclusivity protecting PEDMARK

NEW PRODUCT
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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
Exclusivity Expiration: ⤷ Sign Up

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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				⤷ 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

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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
Brazil	112020010726	método para reduzir ototoxicidade em pacientes pediátricos recebendo quimioterapia à base de platina	⤷ Sign Up
Morocco	53101	THIOSULFATE DE SODIUM ANHYDRE ET FORMULATIONS DE CELUI-CI	⤷ Sign Up
South Korea	20210027410	무수 싸이오황산나트륨의 제형	⤷ 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
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
0788511	SPC/GB08/036	United Kingdom	⤷ Sign Up	PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description