FDA Orange Book
Is there a generic for Arakoda?
Arakoda contains tafenoquine. 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 Arakoda (tafenoquine). The Orange Book shows its last listed patent expires December 2, 2035.
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Arakoda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
NDA 210607, held by 60 DEGREES PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Arakoda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10342791 | December 2, 2035 | Method of use | U-2582 | 210607 |
| 11744828 | December 2, 2035 | Method of use | U-2582 | 210607 |
| 10888558 | December 2, 2035 | Method of use | U-2582 | 210607 |
| 12616689 | December 2, 2035 | Method of use | U-2582 | 210607 |
Arakoda NDC codes
Questions
Is there a generic for Arakoda?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Arakoda (tafenoquine). The Orange Book shows its last listed patent expires December 2, 2035.
What is the generic name for Arakoda?
The active ingredient in Arakoda is tafenoquine, per the FDA Orange Book.
When does the Arakoda patent expire?
The last patent listed for Arakoda in the Orange Book expires December 2, 2035. 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.