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-six patent family members in thirty-three countries.
Two suppliers are listed for this compound.
Summary for birch triterpenes
| International Patents: | 86 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| 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 |
| Oregon Health and Science University | Phase 2 |
| National Center for Complementary and Integrative Health (NCCIH) | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|
| Portugal | 2504012 | ⤷ Sign Up | |
| Mexico | 2020006995 | EXTRACTOS DE CORTEZA DE ABEDUL QUE CONTIENEN BETULINA Y SU FORMULACION. (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION.) | ⤷ Sign Up |
| Russian Federation | 2020125679 | БЕТУЛИН-СОДЕРЖАЩИЕ ЭКСТРАКТЫ ИЗ БЕРЕЗОВОЙ КОРЫ И СОСТАВ НА ИХ ОСНОВЕ | ⤷ Sign Up |
| Austria | E423546 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for birch triterpenes
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758555 | 353 5017-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069/001 20160118 |
| 1758555 | 641 | Finland | ⤷ Sign Up | |
| 1758555 | 1690031-8 | Sweden | ⤷ Sign Up | PRODUCT NAME: BETULIN; REG. NO/DATE: EU/1/15/1069 20160118 |
| 1758555 | 16C1003 | France | ⤷ Sign Up | PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
