FDA Orange Book
Generic for Atrovent
Atrovent 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 is ipratropium bromide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AN. Generics match 3 of the 4 Atrovent products the Orange Book lists.
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Atrovent products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, metered, inhalation | 0.018MG/INH | Discontinued | None | 0 | None |
| solution, inhalation | 0.02% | Discontinued | None | 3 | AN |
| spray, metered, nasal | 0.021MG/SPRAY | Discontinued | None | 6 | AB |
| spray, metered, nasal | 0.042MG/SPRAY | Discontinued | None | 6 | AB |
NDA 019085, 020228, 020393, 020394, 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 |
|---|---|---|---|---|
| THE RITEDOSE CORP | 075693 | AN (A-rated, therapeutically equivalent) | January 26, 2001 | 0.02% |
| NEPHRON CORP | 075562 | AN (A-rated, therapeutically equivalent) | September 27, 2001 | 0.02% |
| BAUSCH HEALTH US LLC | 076025 | AB (A-rated, therapeutically equivalent) | March 31, 2003 | 0.021MG/SPRAY |
| BAUSCH HEALTH US LLC | 076103 | AB (A-rated, therapeutically equivalent) | March 31, 2003 | 0.042MG/SPRAY |
| APOTEX INC | 076156 | AB (A-rated, therapeutically equivalent) | April 18, 2003 | 0.021MG/SPRAY |
| APOTEX INC | 076155 | AB (A-rated, therapeutically equivalent) | April 18, 2003 | 0.042MG/SPRAY |
| HIKMA PHARMACEUTICALS USA INC | 076664 | AB (A-rated, therapeutically equivalent) | November 5, 2003 | 0.021MG/SPRAY |
| HIKMA PHARMACEUTICALS USA INC | 076598 | AB (A-rated, therapeutically equivalent) | November 5, 2003 | 0.042MG/SPRAY |
| LUOXIN AUROVITAS PHARMA CHENGDU CO LTD | 206543 | AN (A-rated, therapeutically equivalent) | October 27, 2016 | 0.02% |
| AMNEAL PHARMACEUTICALS LLC | 215104 | AB (A-rated, therapeutically equivalent) | August 16, 2022 | 0.021MG/SPRAY |
| AMNEAL PHARMACEUTICALS LLC | 215105 | AB (A-rated, therapeutically equivalent) | August 16, 2022 | 0.042MG/SPRAY |
| RUBICON RESEARCH LTD | 219221 | AB (A-rated, therapeutically equivalent) | November 15, 2024 | 0.042MG/SPRAY |
| RUBICON RESEARCH LTD | 219222 | AB (A-rated, therapeutically equivalent) | January 14, 2025 | 0.021MG/SPRAY |
| LUPIN INC | 217886 | AB (A-rated, therapeutically equivalent) | January 27, 2025 | 0.042MG/SPRAY |
| LUPIN INC | 217912 | AB (A-rated, therapeutically equivalent) | February 7, 2025 | 0.021MG/SPRAY |
Questions
Is there a generic for Atrovent?
Yes. The generic name for Atrovent is ipratropium bromide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AN. Generics match 3 of the 4 Atrovent products the Orange Book lists.
What is the generic name for Atrovent?
The active ingredient in Atrovent is ipratropium bromide, per the FDA Orange Book.
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.