Prescription medicine
Navepegritide Brand names: Yuviwel
Navepegritide (Yuviwel) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the navepegritide FDA label on DailyMed (effective March 25, 2026, Ascendis Pharma Endocrinology, Inc.); the NDA 219164 record on Drugs@FDA; every navepegritide label on DailyMed.
Highlights of the record
FDA label of March 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageYUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- February 27, 2026 Yuviwel, Ascendis; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 12, 2042 Yuviwel 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
- 2 through July 30, 2026
What is navepegritide used for?
From the label: indications and usageYUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older 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). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. […]
Source: FDA drug label (Yuviwel), Ascendis Pharma Endocrinology, Inc., effective March 25, 2026 (SPL set e01c1197-338f-414c-b804-808e129ebc8c), via openFDA; the full label on DailyMed
Is there a generic for navepegritide (Yuviwel)?
No generic navepegritide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 12 patents for Yuviwel injection: the compound patent runs to January 5, 2037, and the last listed entry to November 12, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 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 navepegritide?
The FDA Adverse Event Reporting System holds 2 reports that list navepegritide 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?
- Navepegritide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other