Orange Book product · Brand (NDA)
MULTAQ
DRONEDARONE HYDROCHLORIDE
At a glance
Jul 01, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 01, 2009
17 yr 3 mo ago
Today
Patent 8410167 expires
Listed method-of-use patent (U-1387) expiration.
Apr 16, 2029
in 2 yr 10 mo
Patent 8410167 expires
Listed method-of-use patent (U-1388) expiration.
Apr 16, 2029
in 2 yr 10 mo
Patent 9107900 expires
Listed method-of-use patent (U-1728) expiration.
Apr 16, 2029
in 2 yr 10 mo
Patent 9107900 expires
Listed method-of-use patent (U-1726) expiration.
Apr 16, 2029
in 2 yr 10 mo
Patent 8602215 expires
Listed method-of-use patent (U-1473) expiration.
Jun 30, 2031
in 5 yr 1 mo
Pharmaceutical detail
Active ingredient
DRONEDARONE HYDROCHLORIDE
Strength
EQ 400MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022425
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8410167 | Apr 16, 2029 | in 2 yr 10 mo | U-1387 |
| 8410167 | Apr 16, 2029 | in 2 yr 10 mo | U-1388 |
| 9107900 | Apr 16, 2029 | in 2 yr 10 mo | U-1728 |
| 9107900 | Apr 16, 2029 | in 2 yr 10 mo | U-1726 |
| 8602215 | Jun 30, 2031 | in 5 yr 1 mo | U-1473 |
