FDA Orange Book
Is there a generic for Bronchitol?
Bronchitol contains mannitol. 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 Bronchitol (mannitol). The Orange Book shows its last listed exclusivity ends October 30, 2027.
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Bronchitol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 40MG | Marketed (Rx) | None | 0 | None |
NDA 202049, held by PHARMAXIS EUROPE LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bronchitol exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-327 | Orphan drug exclusivity | October 30, 2027 | 202049 |
Questions
Is there a generic for Bronchitol?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bronchitol (mannitol). The Orange Book shows its last listed exclusivity ends October 30, 2027.
What is the generic name for Bronchitol?
The active ingredient in Bronchitol is mannitol, 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.