FDA Orange Book
Is there a generic for Spiriva Respimat?
Spiriva Respimat contains tiotropium bromide. 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 Spiriva Respimat (tiotropium bromide). The Orange Book shows its last listed patent expires April 16, 2031.
Run it in Rivvi
Map Spiriva Respimat and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Spiriva Respimat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, inhalation | EQ 0.00125MG BASE/INH | Marketed (Rx) | None | 0 | None |
| spray, metered, inhalation | EQ 0.0025MG BASE/INH | Marketed (Rx) | None | 0 | None |
NDA 021936, 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.
Spiriva Respimat patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7396341 | October 10, 2026 | Drug product | None | 021936 |
| 9027967 | March 31, 2027 | Drug product | None | 021936 |
| 7396341*PED | April 10, 2027 | Method of use | None | 021936 |
| 9027967*PED | September 30, 2027 | Method of use | None | 021936 |
| 7837235 | March 13, 2028 | Drug product | None | 021936 |
| 7837235*PED | September 13, 2028 | Method of use | None | 021936 |
| 8733341 | October 16, 2030 | Drug product | None | 021936 |
| 8733341*PED | April 16, 2031 | Method of use | None | 021936 |
Spiriva Respimat NDC codes
Questions
Is there a generic for Spiriva Respimat?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Spiriva Respimat (tiotropium bromide). The Orange Book shows its last listed patent expires April 16, 2031.
What is the generic name for Spiriva Respimat?
The active ingredient in Spiriva Respimat is tiotropium bromide, per the FDA Orange Book.
When does the Spiriva Respimat patent expire?
The last patent listed for Spiriva Respimat in the Orange Book expires April 16, 2031. 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.
More on Spiriva Respimat and Tiotropium Bromide
- What is Spiriva Respimat used for?FDA label uses
- Is Spiriva Respimat a controlled substance?Federal schedule
- What is Tiotropium Bromide used for?FDA label uses
- Is Tiotropium Bromide a controlled substance?Federal schedule
- Generic for SpirivaFDA Orange Book
- Anticholinergics listFDA drug class
- Spiriva Respimat Medicare Part D coverageBy plan and state
- NDC 0597-0100Spiriva Respimat NDC record
- NDC 0597-0160Spiriva Respimat NDC record