Orange Book product · Brand (NDA)
FORZINITY
ELAMIPRETIDE HYDROCHLORIDE
At a glance
Sep 19, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2025
9 mo ago
Today
Patent 7576061 expires
Listed drug substance patent expiration.
Jan 20, 2027
in 7 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 19, 2030
in 4 yr 4 mo
Exclusivity ends · ODE-551
Orphan-drug exclusivity (7 years)
Sep 19, 2032
in 6 yr 4 mo
Patent 11083771 expires
Listed method-of-use patent (U-4277) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 11083772 expires
Listed method-of-use patent (U-4277) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 11771734 expires
Listed method-of-use patent (U-4277) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 12268724 expires
Listed method-of-use patent (U-4277) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 9687519 expires
Listed method-of-use patent (U-4277) expiration.
Feb 28, 2034
in 7 yr 10 mo
Pharmaceutical detail
Active ingredient
ELAMIPRETIDE HYDROCHLORIDE
Strength
EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 215244
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Sep 19, 2030
in 4 yr 4 mo
- ODE-551Orphan-drug exclusivity (7 years)
Sep 19, 2032
in 6 yr 4 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7576061 | Jan 20, 2027 | in 7 mo | SubstanceProduct |
| 11083771 | Feb 28, 2034 | in 7 yr 10 mo | U-4277 |
| 11083772 | Feb 28, 2034 | in 7 yr 10 mo | U-4277 |
| 11771734 | Feb 28, 2034 | in 7 yr 10 mo | U-4277 |
| 12268724 | Feb 28, 2034 | in 7 yr 10 mo | U-4277 |
| 9687519 | Feb 28, 2034 | in 7 yr 10 mo | U-4277 |

