FDA Orange Book
Generic for Atrovent HFA
Atrovent HFA contains ipratropium 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
Yes. The generic name for Atrovent HFA is ipratropium bromide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Atrovent HFA products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.021MG/INH | Marketed (Rx) | AB | 1 | AB |
NDA 021527, 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.
Approved generic ipratropium bromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ARMSTRONG PHARMACEUTICALS INC | 217953 | AB (A-rated, therapeutically equivalent) | February 23, 2026 | 0.021MG/INH |
Atrovent HFA patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8474447 | January 17, 2030 | Drug product | None | 021527 |
Atrovent HFA NDC codes
Questions
Is there a generic for Atrovent HFA?
Yes. The generic name for Atrovent HFA is ipratropium bromide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Atrovent HFA?
The active ingredient in Atrovent HFA is ipratropium bromide, per the FDA Orange Book.
When does the Atrovent HFA patent expire?
The last patent listed for Atrovent HFA in the Orange Book expires January 17, 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.