FILSUVEZ Drug Patent Profile
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Which patents cover Filsuvez, and when can generic versions of Filsuvez launch?
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
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for FILSUVEZ
*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
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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 2020006995 | EXTRACTOS DE CORTEZA DE ABEDUL QUE CONTIENEN BETULINA Y SU FORMULACION. (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION.) | ⤷ Sign Up |
| 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 |
| Lithuania | 2504012 | ⤷ Sign Up | |
| Eurasian Patent Organization | 023983 | ПРИМЕНЕНИЕ СОДЕРЖАЩЕГО ТРИТЕРПЕНЫ ОЛЕОГЕЛЯ ДЛЯ ЗАЖИВЛЕНИЯ РАН (USE OF AN OLEOGEL CONTAINING TRITERPENE FOR HEALING WOUNDS) | ⤷ Sign Up |
| Australia | 2010323158 | Use of an oleo gel containing triterpene for healing wounds | ⤷ Sign Up |
| Mexico | 2023009676 | EXTRACTOS DE CORTEZA DE ABEDUL QUE CONTIENEN BETULINA Y SU FORMULACION. (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION.) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FILSUVEZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758555 | 353 5017-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069/001 20160118 |
| 1758555 | SPC/GB16/040 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BETULIN; REGISTERED: UK EU/1/15/1069/001 20160118 |
| 1758555 | 122016000067 | Germany | ⤷ Sign Up | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114 |
| 1758555 | 16C1003 | France | ⤷ Sign Up | PRODUCT NAME: BETULINE; REGISTRATION NO/DATE: EU/1/15/1069 20160118 |
| 1758555 | CR 2016 00032 | Denmark | ⤷ Sign Up | PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118 |
| 1758555 | PA2016023 | Lithuania | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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