Orange Book product · Brand (NDA)
TEKTURNA
ALISKIREN HEMIFUMARATE
Brand (NDA)NDA 021985TE ABRX LXO IRELAND
At a glance
Mar 05, 2007
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 05, 2007
19 yr 7 mo ago
Patent 8617595 expires
Listed drug product patent expiration.
Feb 19, 2026
4 mo ago
Today
Patent 8617595*PED expires
Listed listed patent expiration.
Aug 19, 2026
in 2 mo
Pharmaceutical detail
Active ingredient
ALISKIREN HEMIFUMARATE
Strength
EQ 150MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021985
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.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8617595 | Feb 19, 2026 | 4 mo ago | Product |
| 8617595*PED | Aug 19, 2026 | in 2 mo |
