FILSUVEZ Drug Patent Profile
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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
Generic Entry 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:
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Betulin-containing birch bark extracts and their formulation
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Use of an oleogel containing triterpene for healing wounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF BIRCH TRITERPENES FOR THE TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA
Use of an oleogel containing triterpene for healing wounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
TREATMENT OF WOUNDS ASSOCIATED WITH DYSTROPHIC AND JUNCTIONAL EPIDERMOLYSIS BULLOSA (EB) IN ADULT AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 6017959 | ⤷ Try a Trial | |
Canada | 3081624 | EXTRAITS D'ECORCE DE BOULEAU CONTENANT DE LA BETULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION) | ⤷ Try a Trial |
Denmark | 1758555 | ⤷ Try a Trial | |
China | 111356479 | 含有白桦脂醇的桦树皮提取物及其制剂 (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION) | ⤷ Try a Trial |
Russian Federation | 2007102084 | СОДЕРЖАЩИЙ ТРИТЕРПЕН АГЕНТ ОБРАЗОВАНИЯ ОЛЕОГЕЛЯ, СОДЕРЖАЩИЙ ТРИТЕРПЕН ОЛЕОГЕЛЬ И СПОСОБ ПОЛУЧЕНИЯ СОДЕРЖАЩЕГО ТРИТЕРПЕН ОЛЕОГЕЛЯ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FILSUVEZ
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1758555 | 93142 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: BETULINE (EXTRAIT D'ECORCE DE BOULEAU) - EPISALVAN; FIRST REGISTRATION DATE: 20160118 |
1758555 | 122016000067 | Germany | ⤷ Try a Trial | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114 |
1758555 | C 2016 025 | Romania | ⤷ Try a Trial | 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 | CA 2016 00032 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118 |
1758555 | PA2016023 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |