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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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.Hydrogen peroxide has thirty patent family members in seventeen countries.
There are fifty-three drug master file entries for hydrogen peroxide.
Summary for HYDROGEN PEROXIDE
| International Patents: | 30 |
| US Patents: | 6 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 53 |
| Bulk Api Vendors: | 133 |
| Clinical Trials: | 83 |
| Patent Applications: | 5,330 |
| 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 |
Recent Clinical Trials for HYDROGEN PEROXIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pontificia Universidad Javeriana | Phase 2/Phase 3 |
| Hospital Universitario San Ignacio | Phase 2/Phase 3 |
| The University of Texas Health Science Center, Houston | Phase 4 |
Medical Subject Heading (MeSH) Categories 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 | Start Trial | Start Trial | Start Trial | ||||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Aclaris | ESKATA | hydrogen peroxide | SOLUTION;TOPICAL | 209305-001 | Dec 14, 2017 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for HYDROGEN PEROXIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 1365781 | Start Trial |
| New Zealand | 527673 | Start Trial |
| Austria | 397452 | Start Trial |
| Canada | 2946568 | Start Trial |
| World Intellectual Property Organization (WIPO) | 02064151 | Start Trial |
| China | 100508990 | Start Trial |
| Denmark | 3134061 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HYDROGEN PEROXIDE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2523731 | 24/2020 | Austria | Start Trial | PRODUCT NAME: OSILODROSTAT ODER PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, EINSCHLIESSLICH OSILODROSTATDIHYDROGENPHOSPHAT; REGISTRATION NO/DATE: EU/1/19/1407 (MITTEILUNG) 20200113 |
| 3106463 | CR 2020 00013 | Denmark | Start Trial | PRODUCT NAME: LAROTRECTINIB OG/ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT LAROTRECTINIBSULFAT, INKLUSIV LAROTRECTINIBHYDROGENSULFAT; REG. NO/DATE: EU/1/19/1385 20190923 |
| 0281459 | 98C0036 | France | Start Trial | 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 | 35/1998 | Austria | Start Trial | PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715 |
| 3106463 | 122020000012 | Germany | Start Trial | PRODUCT NAME: LAROTRECTINIB UND/ODER ANDERE PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE LAROTRECTINIBSULFATE UMFASSEND LAROTRECTINIBHYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/19/1385 20190919 |
| 0605697 | SPC/GB01/008 | United Kingdom | Start Trial | 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 |
| 2787345 | CR 2016 00055 | Denmark | Start 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 |
