FDA Orange Book
Is there a generic for Stiolto Respimat?
Stiolto Respimat contains tiotropium bromide and olodaterol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Stiolto Respimat (tiotropium bromide and olodaterol). The Orange Book shows its last listed patent expires October 16, 2030.
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Stiolto Respimat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, inhalation | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 206756, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Stiolto Respimat patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7396341 | October 10, 2026 | Drug product | None | 206756 |
| 7727984 | January 19, 2027 | Drug substance | None | 206756 |
| 9027967 | March 31, 2027 | Drug product | None | 206756 |
| 7396341*PED | April 10, 2027 | Method of use | None | 206756 |
| 7837235 | March 13, 2028 | Drug product | None | 206756 |
| 7837235*PED | September 13, 2028 | Method of use | None | 206756 |
| 8733341 | October 16, 2030 | Drug product | None | 206756 |
Stiolto Respimat NDC codes
Questions
Is there a generic for Stiolto Respimat?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Stiolto Respimat (tiotropium bromide and olodaterol). The Orange Book shows its last listed patent expires October 16, 2030.
What is the generic name for Stiolto Respimat?
The active ingredient in Stiolto Respimat is tiotropium bromide and olodaterol, per the FDA Orange Book.
When does the Stiolto Respimat patent expire?
The last patent listed for Stiolto Respimat in the Orange Book expires October 16, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.