Hydrogen peroxide - Generic Drug Details

What are the generic 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

Anatomical Therapeutic Chemical (ATC) Classes for hydrogen peroxide

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D08AX	Other antiseptics and disinfectants
D08A	ANTISEPTICS AND DISINFECTANTS
D08	ANTISEPTICS AND DISINFECTANTS
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

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
Denmark	3134061
Canada	2946568	FORMULES DE PEROXYDE ET PROCEDES ET APPLICATEURS POUR LEUR UTILISATION (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
Russian Federation	2016145236	ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ, И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ
Singapore	11201608775X	PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME
Spain	2828711
China	106659643	过氧化物制剂及使用过氧化物制剂的方法和施加器 (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
3106463	CA 2020 00013	Denmark		PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923
0605697	SPC/GB01/008	United Kingdom		PRODUCT NAME: 1-(((3-(2-(DIMETHYLAMINO)ETHYL)INDOL-5-YL)METHYL)SULFONYL)PYRROLIDINE GENERIC NAME ALMOTRIPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY AS ALMOTRIPTAN D,L - HYDROGEN MALATE; REGISTERED: ES 62.877 19991223; UK PL 16973/0005 20001026
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
1968948	122021000074	Germany		PRODUCT NAME: SELUMETINIB (EINSCHLIESSLICH PHARMAZEUTISCH AKZEPTABLER SALZE (INSBESONDERE HYDROGENSULFAT), ESTER, SOLVATE ODER ENANTIOMERE DAVON); REGISTRATION NO/DATE: EU/1/21/1552 20210617
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
1968948	CA 2021 00044	Denmark		PRODUCT NAME: SELUMETINIB, INKLUSIV FARMACEUTISK ACCEPTABLE SALTE (ISAER HYDROGENSULFAT), ESTRE, SOLVATER OG ENANTIOMERE DERAF; REG. NO/DATE: EU/1/21/1552 20210619
2787345	CR 2016 00055	Denmark		PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531