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 |
| 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
*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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2015164427 | ⤷ Sign Up | |
| Brazil | 112016024630 | composição tópica, uso de uma composição tópica e aplicador | ⤷ Sign Up |
| Israel | 248462 | פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same) | ⤷ Sign Up |
| Mexico | 2016013826 | FORMULACIONES DE PEROXIDO Y METODOS Y APLICACIONES PARA UTILIZARLAS. (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME.) | ⤷ Sign Up |
| Russian Federation | 2711662 | ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ (PEROXIDE COMPOSITIONS AND METHODS AND APPLICATORS FOR USE THEREOF) | ⤷ 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 |
|---|---|---|---|---|
| 2523731 | 2020012 | Norway | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV, INKLUDERT OSILODROSTAT DIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200203 |
| 3106463 | 2020004 | Norway | ⤷ Sign Up | PRODUCT NAME: LAROTREKTINIB OG/ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV, SAERLIG LAROTREKTINIBSULFAT INKLUDERT LAROTREKTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20191018 |
| 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 |
| 0281459 | SPC/GB99/001 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715 |
| 2523731 | CA 2020 00025 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
