Orange Book product · Brand (NDA)
SPIRIVA
TIOTROPIUM BROMIDE
Brand (NDA)NDA 021395TE ABRX BOEHRINGER INGELHEIM
At a glance
Jan 30, 2004
Approved
Brand (NDA)
Application
AB
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 30, 2004
22 yr 9 mo ago
Patent 8022082 expires
Listed drug product patent expiration.
Jan 19, 2026
5 mo ago
Today
Patent 8022082*PED expires
Listed listed patent expiration.
Jul 19, 2026
in 1 mo
Pharmaceutical detail
Active ingredient
TIOTROPIUM BROMIDE
Strength
EQ 0.018MG BASE/INH
Dosage form
POWDER
Route
INHALATION
TE code
AB
Application
NDA 021395
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.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8022082 | Jan 19, 2026 | 5 mo ago | ProductU-1186 |
| 8022082*PED | Jul 19, 2026 | in 1 mo |
