FDA Orange Book
Is there a generic for Combivent Respimat?
Combivent Respimat contains ipratropium bromide and albuterol. 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 Combivent Respimat (ipratropium bromide and albuterol). The Orange Book shows its last listed patent expires October 16, 2030.
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Combivent Respimat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, inhalation | EQ 0.1MG BASE/INH;0.02MG/INH | Marketed (Rx) | None | 0 | None |
NDA 021747, 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.
Combivent Respimat patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7396341 | October 10, 2026 | Drug product | None | 021747 |
| 9027967 | March 31, 2027 | Drug product | None | 021747 |
| 7837235 | March 13, 2028 | Drug product | None | 021747 |
| 8733341 | October 16, 2030 | Drug product | None | 021747 |
Combivent Respimat NDC codes
Questions
Is there a generic for Combivent Respimat?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Combivent Respimat (ipratropium bromide and albuterol). The Orange Book shows its last listed patent expires October 16, 2030.
What is the generic name for Combivent Respimat?
The active ingredient in Combivent Respimat is ipratropium bromide and albuterol, per the FDA Orange Book.
When does the Combivent Respimat patent expire?
The last patent listed for Combivent 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.