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 | 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 | ⤷ 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 | ||||
| >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 |
|---|---|---|---|
| Serbia | 55089 | KORIŠĆENJE ULJNIH GELOVA SA TRITERPENIMA ZA ZARASTANJE RANA (USE OF AN OLEO GEL CONTAINING TRITERPENE FOR HEALING WOUNDS) | ⤷ Try a Trial |
| Ukraine | 88308 | АГЕНТ ОБРАЗОВАНИЯ ОЛЕОГЕЛЯ, КОТОРЫЙ СОДЕРЖИТ ТРИТЕРПЕН, ОЛЕОГЕЛЬ И СПОСОБ ЕГО ПОЛУЧЕНИЯ;АГЕНТ УТВОРЕННЯ ОЛЕОГЕЛЮ, ЯКИЙ МІСТИТЬ ТРИТЕРПЕН, ОЛЕОГЕЛЬ І СПОСІБ ЙОГО ОТРИМАННЯ (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, OLEOGEL AND METHOD FOR PRODUCING THEREOF) | ⤷ Try a Trial |
| Slovenia | 2504012 | ⤷ Try a Trial | |
| New Zealand | 552280 | Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel | ⤷ Try a Trial |
| Mexico | 2012005769 | USO DE UN OLEOGEL QUE CONTIENE TRITERPENO PARA CAURAR HERIDAS. (USE OF AN OLEO GEL CONTAINING TRITERPENE FOR HEALING WOUNDS.) | ⤷ 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 |
| >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 | 353 5017-2016 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069/001 20160118 |
| 1758555 | PA2016023 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114 |
| 1758555 | 122016000067 | Germany | ⤷ Try a Trial | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114 |
| 1758555 | C201630042 | Spain | ⤷ Try a Trial | PRODUCT NAME: BETULINA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1069; DATE OF AUTHORISATION: 20160114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1069; DATE OF FIRST AUTHORISATION IN EEA: 20160114 |
| 1758555 | C20160023 00332 | Estonia | ⤷ Try a Trial | PRODUCT NAME: BETULIIN;REG NO/DATE: EU/1/15/1069 18.01.2016 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
