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Last Updated: November 24, 2024

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

SponsorPhase
Minia UniversityPhase 1
National Center for Complementary and Integrative Health (NCCIH)Phase 2
Oregon Health and Science UniversityPhase 2

See all birch triterpenes clinical trials

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 Y ⤷  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
European Patent Office 2504012 UTILISATION D'UN OLÉOGEL CONTENANT DU TRITERPÈNE POUR LA CICATRISATION DE PLAIES (USE OF AN OLEO GEL CONTAINING TRITERPENE FOR HEALING WOUNDS) ⤷  Sign Up
Poland 2504012 ⤷  Sign Up
Lithuania 2504012 ⤷  Sign Up
Japan 2016185996 表皮水泡症の創傷治癒剤 (AGENT FOR HEALING WOUNDS OF EPIDERMOLYSIS BULLOSA) ⤷  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 132016000072478 Italy ⤷  Sign Up PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555 C201630042 Spain ⤷  Sign Up 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 SPC/GB16/040 United Kingdom ⤷  Sign Up PRODUCT NAME: BETULIN; REGISTERED: UK EU/1/15/1069/001 20160118
1758555 641 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.