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| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5702 | None |
| Molecule | Description |
|---|---|
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Synonyms:
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A dry extract from two species of birch bark consisting of naturally occurring substances known as triterpenes, including betulin, betulinic acid, erythrodiol, lupeol and oleanolic acid. It is used in adults and children aged 6 months or older with epidermolysis bullosa but the precise mechanism of action in wound healing is not known.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 21, 2022 | EMA | AMRYT PHARMACEUTICALS DAC | |
| Dec. 18, 2023 | FDA | AMRYT |
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| Source | Code | Description |
|---|---|---|
| MeSH PA | D003879 | Dermatologic Agents |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Epidermolysis bullosa | indication | 61003004 | DOID:2730 |
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| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | 9352041 | Nov. 24, 2030 | USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA |
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | 9827214 | Nov. 24, 2030 | USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA |
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | 11266660 | Jan. 4, 2039 | USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA |
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | 12268695 | Jan. 4, 2039 | USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA |
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | Dec. 18, 2028 | NEW CHEMICAL ENTITY |
| 10% | FILSUVEZ | CHIESI | N215064 | Dec. 18, 2023 | RX | GEL | TOPICAL | Dec. 18, 2030 | TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER |
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| ID | Source |
|---|---|
| DB16536 | DRUGBANK_ID |
| 4044314 | VANDF |
| C3486613 | UMLSCUI |
| CHEBI:758152 | CHEBI |
| CHEMBL4650246 | ChEMBL_ID |
| 369958 | MMSL |
| 42451 | MMSL |
| 019322 | NDDF |
| 1309815 | RXNORM |
| C000731943 | MESH_SUPPLEMENTAL_RECORD_UI |
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