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
Louisiana State University Health Sciences Center in New Orleans	N/A
Synedgen, Inc.	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			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

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
Russian Federation	2711662	ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ (PEROXIDE COMPOSITIONS AND METHODS AND APPLICATORS FOR USE THEREOF)
Singapore	11201608775X	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)
Australia	2015249841	Peroxide formulations and methods and applicators for using the same
South Korea	20170029413	과산화물 제제 및 이를 사용하기 위한 방법 및 어플리케이터 (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME)
Brazil	112016024630	composição tópica, uso de uma composição tópica e aplicador
Denmark	3134061

Supplementary Protection Certificates for HYDROGEN PEROXIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3106463	LUC00150	Luxembourg		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SULFATE DE LAROTRECTINIB, Y COMPRIS L'HYDROGENOSULFATE DE LAROTRECTINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1385 20190923
3106463	11/2020	Austria		PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923
3106463	20C1012	France		PRODUCT NAME: LAROTRECTINIB ET/OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER UN SULFATE DE LAROTRECTINIB TEL QUE L'HYDROGENOSULFATE DE LAROTRECTINIB; NAT. REGISTRATION NO/DATE: EU/1/19/1385 20190923; FIRST REGISTRATION: DE - EU/1/19/1385 20190923
1968948	44/2021	Austria		PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH JEGLICHE PHARMAZEUTISCHE AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFATE), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 (MITTEILUNG) 20210619
3106463	2020004	Norway		PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018
2523731	20C1023	France		PRODUCT NAME: OSILODROSTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, Y COMPRIS LE DIHYDROGENOPHOSPHATE D'OSILODROSTAT; REGISTRATION NO/DATE: EU/1/19/1407 20200113
1968948	LUC00234	Luxembourg		PRODUCT NAME: SELUMETINIB (INCLUANT TOUS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER LE SULFATE D'HYDROGENE), SES ESTERS, SOLVATES ET ENANTIOMERES); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619