Prescription medicine

Birch triterpenes Brand names: Filsuvez

Birch triterpenes (Filsuvez) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the birch triterpenes FDA label on DailyMed (effective July 24, 2026, Chiesi USA, Inc.); the NDA 215064 record on Drugs@FDA; every birch triterpenes label on DailyMed.

Highlights of the record

FDA label of July 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Forms and strengths

100 mg/g

Gel.

On the market

Earliest approval on file: December 18, 2023 Filsuvez, Chiesi; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Last listed patent: January 4, 2039 Filsuvez gel; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 209 through July 30, 2026

What is birch triterpenes used for?

From the label: indications and usage
FILSUVEZ is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older. FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.

Source: FDA drug label (FILSUVEZ), Chiesi USA, Inc., effective July 24, 2026 (SPL set 32ba9194-734c-47d4-84e1-b21e28a85ec5), via openFDA; the full label on DailyMed

Is there a generic for birch triterpenes (Filsuvez)?

No generic birch triterpenes is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 6 patents for Filsuvez gel, the last expiring on January 4, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2023 earliest approval on file
2039 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for birch triterpenes?

The FDA Adverse Event Reporting System holds 209 reports that list birch triterpenes among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 25 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Wound Complication34
Wound (a use or a product term, not a reaction)24
Drug Ineffective (a use or a product term, not a reaction)20
Product Dose Omission Issue (a use or a product term, not a reaction)20
Product Use Issue (a use or a product term, not a reaction)19
Wrong Technique In Product Usage Process (a use or a product term, not a reaction)16
Blister13
Off Label Use (a use or a product term, not a reaction)13

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Birch triterpenes side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other