Orange Book product · Brand (NDA)
VYNDAMAX
TAFAMIDIS
At a glance
May 03, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 03, 2019
7 yr 3 mo ago
Exclusivity ends · ODE-237
Orphan-drug exclusivity (7 years)
May 03, 2026
2 mo ago
Today
Patent 7214695 expires
Listed drug substance patent expiration.
Dec 19, 2026
in 6 mo
Patent 7214696 expires
Listed method-of-use patent (U-2524) expiration.
Dec 19, 2026
in 6 mo
Patent 9770441 expires
Listed drug substance patent expiration.
Aug 31, 2035
in 9 yr 4 mo
Pharmaceutical detail
Active ingredient
TAFAMIDIS
Strength
61MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212161
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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)
- ODE-237Orphan-drug exclusivity (7 years)
May 03, 2026
2 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7214695 | Dec 19, 2026 | in 6 mo | SubstanceProduct |
| 7214696 | Dec 19, 2026 | in 6 mo | U-2524 |
| 9770441 | Aug 31, 2035 | in 9 yr 4 mo | SubstanceProductU-2524 |
