Filsuvez is a drug owned by Chiesi Farmaceutici Spa. It is protected by 6 US drug patents filed from 2024 to 2025 out of which none have expired yet. Filsuvez's patents will be open to challenges from 19 December, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 04, 2039. Details of Filsuvez's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11266660 | Betulin-containing birch bark extracts and their formulation |
Jan, 2039
(12 years from now) | Active |
| US12268695 | Betulin-containing birch bark extracts and their formulation |
Jan, 2039
(12 years from now) | Active |
| US11083733 | Betulin-containing birch bark extracts and their formulation |
Jan, 2039
(12 years from now) | Active |
| US9827214 | Use of an oleogel containing triterpene for healing wounds |
Nov, 2030
(4 years from now) | Active |
| US9352041 | Use of an oleogel containing triterpene for healing wounds |
Nov, 2030
(4 years from now) | Active |
| US8828444 | Triterpene-containing oleogel-forming agent, triterpene-containing oleogel and method for producing a triterpene-containing oleogel |
Jun, 2026
(2 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Filsuvez's patents.
Latest Legal Activities on Filsuvez's Patents
Given below is the list of recent legal activities going on the following patents of Filsuvez.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Sep, 2025 | US11266660 |
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US9352041 |
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US9827214 |
| transaction for FDA Determination of Regulatory Review Period | 26 Aug, 2025 | US8828444 |
| Second letter to regulating agency to determine regulatory review period | 10 Jul, 2025 | US9352041 |
| Second letter to regulating agency to determine regulatory review period | 10 Jul, 2025 | US9827214 |
| Second letter to regulating agency to determine regulatory review period | 10 Jul, 2025 | US8828444 |
| Letter from FDA or Dept of Agriculture re PTE application | 27 Jun, 2025 | US8828444 |
| Letter from FDA or Dept of Agriculture re PTE application | 27 Jun, 2025 | US9827214 |
| Information Disclosure Statement (IDS) Filed | 27 Jun, 2025 | US9352041 |
FDA has granted several exclusivities to Filsuvez. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Filsuvez, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Filsuvez.
Exclusivity Information
Filsuvez holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Filsuvez's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2028 |
| Orphan Drug Exclusivity(ODE-460) | Dec 18, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Filsuvez is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Filsuvez's family patents as well as insights into
ongoing legal events
on those patents.
Filsuvez's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Filsuvez's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 04, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Filsuvez Generics:
There are no approved generic versions for Filsuvez as of now.
About Filsuvez
Filsuvez is a drug owned by Chiesi Farmaceutici Spa. It is used for treating wounds associated with dystrophic and junctional epidermolysis bullosa. Filsuvez uses Birch Triterpenes as an active ingredient. Filsuvez was launched by Chiesi in 2023.
Approval Date:
Filsuvez was approved by FDA for market use on 18 December, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Filsuvez is 18 December, 2023, its NCE-1 date is estimated to be 19 December, 2027.
Active Ingredient:
Filsuvez uses Birch Triterpenes as the active ingredient. Check out other Drugs and Companies using Birch Triterpenes ingredient
Treatment:
Filsuvez is used for treating wounds associated with dystrophic and junctional epidermolysis bullosa.
Dosage:
Filsuvez is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10% | GEL | Prescription | TOPICAL |