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FILSUVEZ Drug Patent Profile

Which patents cover Filsuvez, and what generic alternatives are available?

Filsuvez is a drug marketed by Chiesi and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-three patent family members in thirty-two countries.

The generic ingredient in FILSUVEZ is birch triterpenes. One supplier is listed for this compound. Additional details are available on the birch triterpenes profile page.

DrugPatentWatch^® Generic Entry Outlook for Filsuvez

Filsuvez will be eligible for patent challenges on December 18, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 18, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for FILSUVEZ

International Patents:	83
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in FILSUVEZ?	FILSUVEZ excipients list
DailyMed Link:	FILSUVEZ at DailyMed

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

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

NDA:

215064

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.

US Patents and Regulatory Information for FILSUVEZ

FILSUVEZ is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting FILSUVEZ

FDA Regulatory Exclusivity protecting FILSUVEZ

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

International Patents for FILSUVEZ

See the table below for patents covering FILSUVEZ around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	88308	АГЕНТ ОБРАЗОВАНИЯ ОЛЕОГЕЛЯ, КОТОРЫЙ СОДЕРЖИТ ТРИТЕРПЕН, ОЛЕОГЕЛЬ И СПОСОБ ЕГО ПОЛУЧЕНИЯ;АГЕНТ УТВОРЕННЯ ОЛЕОГЕЛЮ, ЯКИЙ МІСТИТЬ ТРИТЕРПЕН, ОЛЕОГЕЛЬ І СПОСІБ ЙОГО ОТРИМАННЯ (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, OLEOGEL AND METHOD FOR PRODUCING THEREOF)
South Korea	101162991
Serbia	55089	KORIŠĆENJE ULJNIH GELOVA SA TRITERPENIMA ZA ZARASTANJE RANA (USE OF AN OLEO GEL CONTAINING TRITERPENE FOR HEALING WOUNDS)
Poland	1758555
Japan	4468987
European Patent Office	4249057	EXTRAITS D'ÉCORCE DE BOULEAU CONTENANT DE LA BÉTULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION)
Japan	2008503530

Supplementary Protection Certificates for FILSUVEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1758555	32/2016	Austria		PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 (MITTEILUNG) 20160118
1758555	132016000072478	Italy		PRODUCT NAME: ESTRATTO DI CORTECCIA DI BETULLA.(EPISALVAN); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1069, 20160118
1758555	16C1003	France		PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118
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
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	PA2016023	Lithuania		PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114
1758555	1690031-8	Sweden		PRODUCT NAME: BETULIN; REG. NO/DATE: EU/1/15/1069 20160118