Birch triterpenes - Generic Drug Details
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What are the generic drug sources for birch triterpenes and what is the scope of patent protection?
Birch triterpenes
is the generic ingredient in one branded drug marketed by Chiesi and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Birch triterpenes has eighty-three patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for birch triterpenes
| International Patents: | 83 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 2 |
| What excipients (inactive ingredients) are in birch triterpenes? | birch triterpenes excipients list |
| DailyMed Link: | birch triterpenes at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for birch triterpenes
Generic Entry Date for birch triterpenes*:
Constraining patent/regulatory exclusivity:
TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER Dosage:
GEL;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 birch triterpenes
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Minia University | Phase 1 |
| National Center for Complementary and Integrative Health (NCCIH) | Phase 2 |
| Oregon Health and Science University | Phase 2 |
US Patents and Regulatory Information for birch triterpenes
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for birch triterpenes
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20150029031 | USE OF AN OLEOGEL CONTAINING TRITERPENE FOR HEALING WOUNDS | ⤷ Try a Trial |
| Cyprus | 1109066 | ⤷ Try a Trial | |
| New Zealand | 600759 | Use of an oleogel containing triterpene for healing wounds | ⤷ Try a Trial |
| Hungary | E028566 | ⤷ Try a Trial | |
| Canada | 3081624 | EXTRAITS D'ECORCE DE BOULEAU CONTENANT DE LA BETULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION) | ⤷ Try a Trial |
| Mexico | PA06015233 | AGENTE QUE FORMA OLEOGEL QUE CONTIENE TRITERPENO, OLEOGEL QUE CONTIENE TRITERPENO Y METODO PARA PRODUCIR UN OLEOGEL QUE CONTIENE TRITERPENO. (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, TRITERPENE- CONTAINING OLEOGEL AND METHOD FOR PRODUCING A TRITERPENE- CONTAINING OLEOGEL.) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for birch triterpenes
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758555 | 93142 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: BETULINE (EXTRAIT D'ECORCE DE BOULEAU) - EPISALVAN; FIRST REGISTRATION DATE: 20160118 |
| 1758555 | 32/2016 | Austria | ⤷ Try a Trial | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 (MITTEILUNG) 20160118 |
| 1758555 | 300823 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: BERKENSCHORSEXTRACT VAN BETULA PENDULA ROTH, BETULA PUBESCENS EHRH, ALSOOK HYBRIDEN VAN BEIDE SOORTEN MET N-HEPTAAN ALS EXTRACTIEMIDDEL; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114 |
| 1758555 | PA2016023,C1758555 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114 |
| 1758555 | 2016/031 | Ireland | ⤷ Try a Trial | PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REGISTRATION NO/DATE: EU/1/15/1069 20160114 |
| 1758555 | 132016000072478 | Italy | ⤷ Try a Trial | PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
