Birch triterpenes - Generic Drug Details

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What are the generic 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^: ⤷ Sign Up* 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

See all birch triterpenes clinical trials

US Patents and Regulatory Information for birch triterpenes

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Glossary

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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	Y			⤷ 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	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

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Country	Patent Number	Title	Estimated Expiration
Denmark	1758555		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011064271		⤷ Sign Up
Luxembourg	93142		⤷ Sign Up
France	16C1003		⤷ Sign Up
European Patent Office	4249057	EXTRAITS D'ÉCORCE DE BOULEAU CONTENANT DE LA BÉTULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION)	⤷ Sign Up
Japan	6017959		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for birch triterpenes

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	32/2016	Austria	⤷ Sign Up	PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 (MITTEILUNG) 20160118
1758555	CA 2016 00032	Denmark	⤷ Sign Up	PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 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	132016000072478	Italy	⤷ Sign Up	PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555	SPC/GB16/040	United Kingdom	⤷ Sign Up	PRODUCT NAME: BETULIN; REGISTERED: UK EU/1/15/1069/001 20160118
1758555	CR 2016 00032	Denmark	⤷ Sign Up	PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118
>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.

Summary for birch triterpenes

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for birch triterpenes

Recent Clinical Trials for birch triterpenes

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for birch triterpenes