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
Oregon Health and Science University	Phase 2
National Center for Complementary and Integrative Health (NCCIH)	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
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
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064-001	Dec 18, 2023		RX	Yes	Yes

International Patents for birch triterpenes

Country	Patent Number	Title	Estimated Expiration
South Korea	20200106487	베툴린 함유 자작나무 껍질 추출물 및 그 제형
Norway	2016012
Russian Federation	2430717	СОДЕРЖАЩИЙ ТРИТЕРПЕН АГЕНТ ОБРАЗОВАНИЯ ОЛЕОГЕЛЯ, СОДЕРЖАЩИЙ ТРИТЕРПЕН ОЛЕОГЕЛЬ, И СПОСОБ ПОЛУЧЕНИЯ СОДЕРЖАЩЕГО ТРИТЕРПЕН ОЛЕОГЕЛЯ (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, TRITERPENE-CONTAINING OLEOGEL AND METHOD FOR PRODUCING TRITERPENE-CONTAINING OLEOGEL)
Brazil	112012012499	uso de um óleo gel contendo triterpeno para cura de feridas
Denmark	1758555
Japan	7358353

Supplementary Protection Certificates for birch triterpenes

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	132016000072478	Italy		PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555	C201630042	Spain		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	CR 2016 00032	Denmark		PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118
1758555	C20160023 00332	Estonia		PRODUCT NAME: BETULIIN;REG NO/DATE: EU/1/15/1069 18.01.2016
1758555	CA 2016 00032	Denmark		PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118
1758555	122016000067	Germany		PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114