FDA Orange Book · active-ingredient family
Dronedarone hydrochloride
Dronedarone hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MULTAQ · NDA 022425
1
Brand (NDA)
1
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MULTAQRLD | SANOFI AVENTIS US | NDA 022425 | — | Jul 01, 2009 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DRONEDARONE HYDROCHLORIDE | LUPIN | ANDA 205904 | — | Jan 31, 2024 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8410167 | Apr 16, 2029 | in 2 yr 10 mo | U-1387 |
| 9107900 | Apr 16, 2029 | in 2 yr 10 mo | U-1728 |
| 8602215 | Jun 30, 2031 | in 5 yr 1 mo | U-1473 |
Dronedarone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
