Prescription medicine
Etranacogene dezaparvovec Brand names: Hemgenix
Etranacogene dezaparvovec (Hemgenix) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the etranacogene dezaparvovec FDA label on DailyMed (effective May 1, 2026); every etranacogene dezaparvovec label on DailyMed.
Highlights of the record
FDA label of May 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageHEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
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
- 59 through July 30, 2026
What is etranacogene dezaparvovec used for?
From the label: indications and usageHEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes. HEMGENIX is an adeno-associated virus vector-based gene therapy indicated for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: Currently use Factor IX prophylaxis therapy, or Have current or historical life-threatening hemorrhage, or Have repeated, serious spontaneous bleeding episodes.
Source: FDA drug label (HEMGENIX), CSL Behring, effective May 1, 2026 (SPL set 35b2db65-4c6c-4173-ab56-b2bca69193bd), via openFDA; the full label on DailyMed
Is there a generic for etranacogene dezaparvovec (Hemgenix)?
No generic etranacogene dezaparvovec is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for etranacogene dezaparvovec?
The FDA Adverse Event Reporting System holds 59 reports that list etranacogene dezaparvovec 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 8 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?
- Etranacogene dezaparvovec side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other