Hydrogen peroxide - Generic Drug Details

What are the generic drug sources for hydrogen peroxide and what is the scope of patent protection?

Hydrogen peroxide is the generic ingredient in one branded drug marketed by Aclaris and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Hydrogen peroxide has eighteen patent family members in sixteen countries.

There are four drug master file entries for hydrogen peroxide.

Summary for hydrogen peroxide

International Patents:	18
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Raw Ingredient (Bulk) Api Vendors:	155
Clinical Trials:	98
Patent Applications:	5,670
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for hydrogen peroxide
What excipients (inactive ingredients) are in hydrogen peroxide?	hydrogen peroxide excipients list
DailyMed Link:	hydrogen peroxide at DailyMed

See drug prices for hydrogen peroxide

See drug sales revenues for hydrogen peroxide

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for hydrogen peroxide

Dosage:

SOLUTION;TOPICAL

^*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.

Recent Clinical Trials for hydrogen peroxide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Synedgen, Inc.	N/A
Louisiana State University Health Sciences Center in New Orleans	N/A
University of Baghdad	Phase 3

See all hydrogen peroxide clinical trials

Medical Subject Heading (MeSH) Categories for hydrogen peroxide

Anti-Infective Agents, Local

Oxidants

US Patents and Regulatory Information for hydrogen peroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017		DISCN	Yes	No			Y

Expired US Patents for hydrogen peroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aclaris	ESKATA	hydrogen peroxide	SOLUTION;TOPICAL	209305-001	Dec 14, 2017

International Patents for hydrogen peroxide

Country	Patent Number	Title	Estimated Expiration
Australia	2015249841	Peroxide formulations and methods and applicators for using the same
Portugal	3134061
Israel	248462	פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same)
Japan	2017513907	過酸化物製剤ならびにその使用のための方法および塗布器
World Intellectual Property Organization (WIPO)	2015164427
Mexico	2016013826	FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.)
Canada	2946568	FORMULES DE PEROXYDE ET PROCEDES ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)

Supplementary Protection Certificates for hydrogen peroxide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1968948	2021C/549	Belgium		PRODUCT NAME: SELUMETINIB (Y COMPRIS TOUS SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER HYDROGENOSULFATE), ESTERS, SOLVATES OU ENANTIOMERES DE CEUX-CI); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619
1419152	CR 2012 00019	Denmark		PRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
3106463	2020C/507	Belgium		PRODUCT NAME: VITRAKVI - LAROTRECTINIB ET/OU SES SELS ACCEPTABLES EN PHARMACIE, EN PARTICULIER L'HYDROGENO SULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
2523731	2090024-7	Sweden		PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113
2523731	CA 2020 00025	Denmark		PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113
3106463	2090009-8	Sweden		PRODUCT NAME: LAROTRECTINIB,OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REG. NO/DATE: EU/1/19/1385 20190923
2523731	2020012	Norway		PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203