Orange Book product · Brand (NDA)
STIOLTO RESPIMAT
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
At a glance
May 21, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 21, 2015
11 yr 3 mo ago
Today
Patent 7396341 expires
Listed drug product patent expiration.
Oct 10, 2026
in 4 mo
Patent 7727984 expires
Listed drug substance patent expiration.
Jan 19, 2027
in 7 mo
Patent 9027967 expires
Listed drug product patent expiration.
Mar 31, 2027
in 10 mo
Patent 7396341*PED expires
Listed listed patent expiration.
Apr 10, 2027
in 10 mo
Patent 7837235 expires
Listed drug product patent expiration.
Mar 13, 2028
in 1 yr 9 mo
Patent 7837235*PED expires
Listed listed patent expiration.
Sep 13, 2028
in 2 yr 3 mo
Patent 8733341 expires
Listed drug product patent expiration.
Oct 16, 2030
in 4 yr 5 mo
Pharmaceutical detail
Active ingredient
OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Strength
EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH
Dosage form
SPRAY, METERED
Route
INHALATION
TE code
Not listed
Application
NDA 206756
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7396341 | Oct 10, 2026 | in 4 mo | ProductDelisted |
| 7727984 | Jan 19, 2027 | in 7 mo | Substance |
| 9027967 | Mar 31, 2027 | in 10 mo | ProductDelisted |
| 7396341*PED | Apr 10, 2027 | in 10 mo | |
| 7837235 | Mar 13, 2028 | in 1 yr 9 mo | ProductDelisted |
| 7837235*PED | Sep 13, 2028 | in 2 yr 3 mo | |
| 8733341 | Oct 16, 2030 | in 4 yr 5 mo | ProductDelisted |
