~ Buy the FILSUVEZ (birch triterpenes) Drug Profile, 2024 PDF Report in the Report Store ~

FILSUVEZ Drug Patent Profile

✉ Email this page to a colleague

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-six patent family members in thirty-three countries.

The generic ingredient in FILSUVEZ is birch triterpenes. Two suppliers are 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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for FILSUVEZ?
What are the global sales for FILSUVEZ?
What is Average Wholesale Price for FILSUVEZ?

Summary for FILSUVEZ

International Patents:	86
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in FILSUVEZ?	FILSUVEZ excipients list
DailyMed Link:	FILSUVEZ at DailyMed

Drug patent expirations by year for FILSUVEZ

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

Generic Entry Date for FILSUVEZ^: ⤷ 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 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of FILSUVEZ is ⤷ Sign Up.

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

Betulin-containing birch bark extracts and their formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Betulin-containing birch bark extracts and their formulation
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA

Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Use of an oleogel containing triterpene for healing wounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA

FDA Regulatory Exclusivity protecting FILSUVEZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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
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
>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 FILSUVEZ

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

Subscribe to access the full database, or Sign Up
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
Portugal	2504012		⤷ Sign Up
Mexico	PA06015233	AGENTE QUE FORMA OLEOGEL QUE CONTIENE TRITERPENO, OLEOGEL QUE CONTIENE TRITERPENO Y METODO PARA PRODUCIR UN OLEOGEL QUE CONTIENE TRITERPENO. (TRITERPENE-CONTAINING OLEOGEL-FORMING AGENT, TRITERPENE- CONTAINING OLEOGEL AND METHOD FOR PRODUCING A TRITERPENE- CONTAINING OLEOGEL.)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for FILSUVEZ

Subscribe to access the full database, or Sign Up
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
1758555	PA2016023	Lithuania	⤷ Sign Up	PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114
1758555	16C1003	France	⤷ Sign Up	PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description