FDA Orange Book
Is there a generic for Multaq?
Multaq contains dronedarone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Multaq (dronedarone). The Orange Book shows its last listed patent expires June 30, 2031.
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Multaq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 400MG BASE | Marketed (Rx) | None | 0 | None |
NDA 022425, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Multaq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8410167 | April 16, 2029 | Method of use | U-1387 | 022425 |
| 9107900 | April 16, 2029 | Method of use | U-1728 | 022425 |
| 9107900 | April 16, 2029 | Method of use | U-1726 | 022425 |
| 8410167 | April 16, 2029 | Method of use | U-1388 | 022425 |
| 8602215 | June 30, 2031 | Method of use | U-1473 | 022425 |
Multaq NDC codes
Questions
Is there a generic for Multaq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Multaq (dronedarone). The Orange Book shows its last listed patent expires June 30, 2031.
What is the generic name for Multaq?
The active ingredient in Multaq is dronedarone, per the FDA Orange Book.
When does the Multaq patent expire?
The last patent listed for Multaq in the Orange Book expires June 30, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.