FDA Orange Book · active-ingredient family
Dronedarone hydrochloride
Dronedarone hydrochloride: 1 brand, 1 generic; first approved Jul 01, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
3
Next patent expiry
Apr 16, 2029
in 2 yr 6 mo
Brand (NDA) products
Originator applications
- SANOFI AVENTIS USNDA 0224252009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx -
Generic (ANDA) products (1)
Abbreviated applications
- DRONEDARONE HYDROCHLORIDELUPINANDA 2059042024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8410167 | in 2 yr 6 mo | U-1387 | |
| 9107900 | in 2 yr 6 mo | U-1728 | |
| 8602215 | in 4 yr 9 mo | U-1473 |
Approval history
FDA approval span
First approval
17 yr 7 mo ago
Most recent approval
2 yr 9 mo ago
Approvals span 2009–2024 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Dronedarone hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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