FDA Orange Book
Is there a generic for Savaysa?
Savaysa contains edoxaban. 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 Savaysa (edoxaban). The Orange Book shows its last listed patent expires March 28, 2028 and its last listed exclusivity ends October 18, 2026.
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Savaysa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 15MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 60MG BASE | Marketed (Rx) | None | 0 | None |
NDA 206316, held by DAIICHI SANKYO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Savaysa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7365205 | April 18, 2027 | Drug substance | None | 206316 |
| 9149532 | March 28, 2028 | Drug product | None | 206316 |
Savaysa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-14 | Miscellaneous | October 18, 2026 | 206316 |
Savaysa NDC codes
Questions
Is there a generic for Savaysa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Savaysa (edoxaban). The Orange Book shows its last listed patent expires March 28, 2028 and its last listed exclusivity ends October 18, 2026.
What is the generic name for Savaysa?
The active ingredient in Savaysa is edoxaban, per the FDA Orange Book.
When does the Savaysa patent expire?
The last patent listed for Savaysa in the Orange Book expires March 28, 2028. 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.