FDA Orange Book · active-ingredient family
Tiotropium bromide
Tiotropium bromide is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SPIRIVA RESPIMAT · NDA 021936
2
Brand (NDA)
1
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPIRIVA RESPIMATRLD×2 | BOEHRINGER INGELHEIM | NDA 021936 | — | Sep 15, 2015 | |
| SPIRIVARLD | BOEHRINGER INGELHEIM | NDA 021395 | AB | Jan 30, 2004 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TIOTROPIUM BROMIDE | LUPIN | ANDA 211287 | AB | Jun 20, 2023 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8022082 | Jan 19, 2026 | 5 mo ago | ProductU-1186 |
| 8022082*PED | Jul 19, 2026 | in 1 mo | |
| 7396341 | Oct 10, 2026 | in 4 mo | ProductDelisted |
| 9027967 | Mar 31, 2027 | in 10 mo | ProductDelisted |
| 7396341*PED | Apr 10, 2027 | in 10 mo | |
| 9027967*PED | Sep 30, 2027 | in 1 yr 4 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 |
| 8733341*PED | Apr 16, 2031 | in 4 yr 11 mo |
Tiotropium bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
