Orange Book product · Brand (NDA)
VYNDAQEL
TAFAMIDIS MEGLUMINE
At a glance
May 03, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
2
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
Pharmaceutical detail
Active ingredient
TAFAMIDIS MEGLUMINE
Strength
20MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 211996
Product number
001
Marketing status
DISCN
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)
- ODE-237Orphan-drug exclusivity (7 years)
May 03, 2026
2 mo ago
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7214695 | Dec 19, 2026 | in 6 mo | SubstanceProduct |
| 7214696 | Dec 19, 2026 | in 6 mo | U-2524 |
