Hydrogen peroxide - Generic Drug Details
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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: | 99 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for hydrogen peroxide
Generic Entry Date for hydrogen peroxide*:
Constraining patent/regulatory exclusivity:
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 |
---|---|
Universidade Federal do Para | Phase 3 |
Synedgen, Inc. | N/A |
Louisiana State University Health Sciences Center in New Orleans | N/A |
Medical Subject Heading (MeSH) Categories for hydrogen peroxide
Anatomical Therapeutic Chemical (ATC) Classes for hydrogen peroxide
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for hydrogen peroxide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | 2016013826 | FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.) | ⤷ Sign Up |
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) | ⤷ Sign Up |
Canada | 2946568 | FORMULES DE PEROXYDE ET PROCEDES ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME) | ⤷ Sign Up |
Poland | 3134061 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 2015164427 | ⤷ Sign Up | |
Australia | 2015249841 | Peroxide formulations and methods and applicators for using the same | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for hydrogen peroxide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0281459 | 98C0036 | France | ⤷ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 |
2523731 | CR 2020 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113 |
1968948 | CR 2021 00044 | Denmark | ⤷ Sign Up | PRODUCT NAME: SELUMETINIB HYDROGENSULFAT OG SOLVATER OG ANHYDRID FORMER DERAF; REG. NO/DATE: EU/1/21/1552 20210619 |
3106463 | LUC00150 | Luxembourg | ⤷ Sign Up | 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 | 2020/009 | Ireland | ⤷ Sign Up | PRODUCT NAME: LAROTRECTINIB AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, PARTICULARLY LAROTRECTINIB SULFATE INCLUDING LAROTRECTINIB HYDROGEN SULFATE; REGISTRATION NO/DATE: EU/1/19/1385 20190923 |
2787345 | CA 2016 00055 | Denmark | ⤷ Sign Up | PRODUCT NAME: MIGALASTAT ELLER ET SALT HERAF, HERUNDER HYDROGENKLORIDSALTET; REG. NO/DATE: EU/1/15/1082 20160531 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |