Orange Book product · Brand (NDA)
ZEGALOGUE
DASIGLUCAGON HYDROCHLORIDE
At a glance
Mar 22, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2021
5 yr 4 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 22, 2026
3 mo ago
Today
Patent 11795204 expires
Listed method-of-use patent (U-3752) expiration.
Jan 06, 2034
in 7 yr 8 mo
Patent 10442847 expires
Listed drug substance patent expiration.
Mar 22, 2035
in 8 yr 11 mo
Pharmaceutical detail
Active ingredient
DASIGLUCAGON HYDROCHLORIDE
Strength
EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 214231
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NCENew chemical entity exclusivity (5 years)
Mar 22, 2026
3 mo ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11795204 | Jan 06, 2034 | in 7 yr 8 mo | U-3752 |
| 10442847 | Mar 22, 2035 | in 8 yr 11 mo | SubstanceProduct |
