Prescription medicine
Elamipretide Brand names: Forzinity
Elamipretide (Forzinity) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the elamipretide FDA label on DailyMed (effective December 10, 2025, Stealth Biotherapeutics Inc.); the NDA 215244 record on Drugs@FDA; every elamipretide label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg.
Forms and strengths
- 280 mg/3.5ml
Injection.
On the market
- Earliest approval on file
- September 19, 2025 Forzinity, Stealth Biotheraps; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- February 28, 2034 Forzinity 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
What is elamipretide used for?
From the label: indications and usageFORZINITY is indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. This indication is approved under accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. FORZINITY™ is a mitochondrial cardiolipin binder indicated to improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30 kg. […]
Source: FDA drug label (FORZINITY), Stealth Biotherapeutics Inc., effective December 10, 2025 (SPL set 146bf34c-76f2-48db-ac07-fb29cce2cd75), via openFDA; the full label on DailyMed
Is there a generic for elamipretide (Forzinity)?
No generic elamipretide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Forzinity injection: the compound patent runs to January 20, 2027, and the last listed entry to February 28, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2034 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the elamipretide label say about other medicines?
The elamipretide label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings and precautions | If a serious hypersensitivity reaction occurs, do not administer further doses of FORZINITY and institute appropriate emergency treatment, including epinephrine, antihistamines, and corticosteroids as clinically indicated. |
Source: FDA drug label (FORZINITY), Stealth Biotherapeutics Inc., effective December 10, 2025 (SPL set 146bf34c-76f2-48db-ac07-fb29cce2cd75), via openFDA; the full label on DailyMed
What next?
- Check an interaction
- what two or more labels say about each other