Orange Book product · Brand (NDA)
SAVAYSA
EDOXABAN TOSYLATE
At a glance
Jan 08, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 08, 2015
11 yr 7 mo ago
Today
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Oct 18, 2026
in 4 mo
Patent 7365205 expires
Listed drug substance patent expiration.
Apr 18, 2027
in 10 mo
Patent 9149532 expires
Listed drug product patent expiration.
Mar 28, 2028
in 1 yr 10 mo
Pharmaceutical detail
Active ingredient
EDOXABAN TOSYLATE
Strength
EQ 15MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 206316
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-14New use / labeling-change exclusivity (3 years)
Oct 18, 2026
in 4 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7365205 | Apr 18, 2027 | in 10 mo | Substance |
| 9149532 | Mar 28, 2028 | in 1 yr 10 mo | Product |
