Orange Book product · Brand (NDA)
DAWNZERA (AUTOINJECTOR)
DONIDALORSEN SODIUM
At a glance
Aug 21, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 21, 2025
10 mo ago
Today
Exclusivity ends · ODE-550
Orphan-drug exclusivity (7 years)
Aug 21, 2032
in 6 yr 3 mo
Patent 9315811 expires
Listed method-of-use patent (U-3010) expiration.
Oct 21, 2032
in 6 yr 5 mo
Patent 9127276 expires
Listed drug substance patent expiration.
May 01, 2034
in 8 yr
Patent 9181549 expires
Listed drug substance patent expiration.
May 01, 2034
in 8 yr
Patent 9670492 expires
Listed drug substance patent expiration.
Aug 28, 2034
in 8 yr 4 mo
Patent 10294477 expires
Listed drug substance patent expiration.
May 01, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
DONIDALORSEN SODIUM
Strength
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 219407
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 (1)
- ODE-550Orphan-drug exclusivity (7 years)
Aug 21, 2032
in 6 yr 3 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9315811 | Oct 21, 2032 | in 6 yr 5 mo | U-3010 |
| 9127276 | May 01, 2034 | in 8 yr | Substance |
| 9181549 | May 01, 2034 | in 8 yr | Substance |
| 9670492 | Aug 28, 2034 | in 8 yr 4 mo | Substance |
| 10294477 | May 01, 2035 | in 9 yr | SubstanceProductU-3010 |
