Prescription medicine
Vosoritide Brand names: Voxzogo
Vosoritide (Voxzogo) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the vosoritide FDA label on DailyMed (effective November 25, 2025, BioMarin Pharmaceutical Inc.); the NDA 214938 record on Drugs@FDA; every vosoritide label on DailyMed.
Highlights of the record
FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- November 19, 2021 Voxzogo, Biomarin Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 11, 2042 Voxzogo injection; 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
- 1 through July 30, 2026
What is vosoritide used for?
From the label: indications and usageVOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). VOXZOGO is a C type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. […]
Source: FDA drug label (VOXZOGO 0.4mg), BioMarin Pharmaceutical Inc., effective November 25, 2025 (SPL set 228e8560-04a4-4bb1-a81f-29531a9e4d27), via openFDA; the full label on DailyMed
Is there a generic for vosoritide (Voxzogo)?
No generic vosoritide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Voxzogo injection: the compound patent runs to June 11, 2035, and the last listed entry to July 11, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2042 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 vosoritide?
The FDA Adverse Event Reporting System holds 1 report that list vosoritide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Vosoritide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other