Orange Book product · Brand (NDA)
WIDAPLIK
AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
At a glance
Jun 05, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 05, 2025
1 yr 1 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Jun 05, 2028
in 2 yr
Patent 10322117 expires
Listed drug product patent expiration.
Jan 23, 2038
in 11 yr 9 mo
Patent 12465599 expires
Listed drug product patent expiration.
Jan 23, 2038
in 11 yr 9 mo
Pharmaceutical detail
Active ingredient
AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN
Strength
EQ 1.25MG BASE;0.625MG;10MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 219423
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)
- NPNew product exclusivity (3 years)
Jun 05, 2028
in 2 yr
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10322117 | Jan 23, 2038 | in 11 yr 9 mo | Product |
| 12465599 | Jan 23, 2038 | in 11 yr 9 mo | Product |
