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 six patents protecting this drug.
This drug has eighty-eight 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
AI Deep Research
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: | 88 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Clinical Trials: | 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.
Recent Clinical Trials for FILSUVEZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiesi Farmaceutici S.p.A. | PHASE3 |
US Patents and Regulatory Information for FILSUVEZ
FILSUVEZ is protected by six US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FILSUVEZ is ⤷ Start 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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for FILSUVEZ
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Chiesi | FILSUVEZ | birch triterpenes | GEL;TOPICAL | 215064-001 | Dec 18, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for FILSUVEZ
See the table below for patents covering FILSUVEZ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2019205091 | ⤷ Start Trial | |
| Brazil | 112020009867 | composição formadora de cremosidade | ⤷ Start Trial |
| Canada | 3081624 | EXTRAITS D'ECORCE DE BOULEAU CONTENANT DE LA BETULINE ET LEUR FORMULATION (BETULIN-CONTAINING BIRCH BARK EXTRACTS AND THEIR FORMULATION) | ⤷ Start 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) | ⤷ Start Trial |
| Colombia | 2020006242 | Extractos de corteza de abedul que contienen betulina y su formulación | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FILSUVEZ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758555 | PA2016023 | Lithuania | ⤷ Start Trial | PRODUCT NAME: BERZO ZIEVES EKSTRAKTAS; REGISTRATION NO/DATE: EU/1/15/1069/001 20160114 |
| 1758555 | 300823 | Netherlands | ⤷ Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY |
| 1758555 | 93142 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: BETULINE (EXTRAIT D'ECORCE DE BOULEAU) - EPISALVAN; FIRST REGISTRATION DATE: 20160118 |
| 1758555 | 122016000067 | Germany | ⤷ Start Trial | PRODUCT NAME: BETULIN; REGISTRATION NO/DATE: EU/1/15/1069 20160114 |
| 1758555 | CA 2016 00032 | Denmark | ⤷ Start Trial | PRODUCT NAME: BETULIN (BIRCH BARK EXTRACT); REG. NO/DATE: EU/1/15/1069/001 20160118 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for FILSUVEZ
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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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