Birch triterpenes - Generic Drug Details

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

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

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
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes			Y
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes			Y

International Patents for birch triterpenes

Country	Patent Number	Title	Estimated Expiration
Japan	6017959
Canada	3081624	EXTRAITS D'ECORCE DE BOULEAU CONTENANT DE LA BETULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION)
Denmark	1758555

Supplementary Protection Certificates for birch triterpenes

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	93142	Luxembourg		PRODUCT NAME: BETULINE (EXTRAIT D'ECORCE DE BOULEAU) - EPISALVAN; FIRST REGISTRATION DATE: 20160118
1758555	122016000067	Germany		PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114
1758555	C 2016 025	Romania		PRODUCT NAME: BETULINA(EXTRACT DIN SCOARTA DE MESTEACAN); NATIONAL AUTHORISATION NUMBER: EU/1/15/1069/001; DATE OF NATIONAL AUTHORISATION: 20160114; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1069/001; DATE OF FIRST AUTHORISATION IN EEA: 20160114