Hydrogen peroxide - Generic Drug Details
✉ Email this page to a colleague
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 |
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 |
|---|---|
| Synedgen, Inc. | N/A |
| Louisiana State University Health Sciences Center in New Orleans | N/A |
| University of Baghdad | Phase 3 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for hydrogen peroxide
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Portugal | 3134061 | ⤷ Try a Trial | |
| European Patent Office | 3134061 | FORMULES DE PEROXYDE ET PROCÉDÉS ET APPLICATEURS POUR LEUR UTILISATION (PEROXIDE FORMULATIONS AND METHODS AND APPLICATORS FOR USING THE SAME) | ⤷ Try a Trial |
| Israel | 248462 | פורמולציות פראוקסיד ושיטות ויישומים לשימוש בהן (Peroxide formulations and methods and applicators for using the same) | ⤷ Try a Trial |
| Spain | 2828711 | ⤷ Try a Trial | |
| Denmark | 3134061 | ⤷ Try a Trial | |
| Russian Federation | 2016145236 | ПЕРОКСИДНЫЕ КОМПОЗИЦИИ И СПОСОБЫ, И АППЛИКАТОРЫ ДЛЯ ИХ ПРИМЕНЕНИЯ | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for hydrogen peroxide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3106463 | 11/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB UND/ODER PHARMAZEUTISCH AKZEPTABLE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFAT, EINSCHLIESSLICH LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190923 |
| 2523731 | 2090024-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: OSILODROSTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING OSILODROSTAT DIHYDROGEN PHOSPHATE; REG. NO/DATE: EU/1/19/1407 20200113 |
| 3106463 | 122020000012 | Germany | ⤷ Try a Trial | PRODUCT NAME: LAROTRECTINIB ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, EINSCHLIESSLICH LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
| 2523731 | CR 2020 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113 |
| 2523731 | CA 2020 00025 | Denmark | ⤷ Try a Trial | PRODUCT NAME: OSILODROSTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER OSILODROSTATDIHYDROGENFOSFAT; REG. NO/DATE: EU/1/19/1407 20200113 |
| 2787345 | CR 2016 00055 | Denmark | ⤷ Try a Trial | 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 |
