FDA Orange Book
Is there a generic for Tudorza Pressair?
Tudorza Pressair contains aclidinium 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 Tudorza Pressair (aclidinium bromide). The Orange Book shows its last listed patent expires March 13, 2029.
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Tudorza Pressair products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, metered, inhalation | 0.4MG/INH | Marketed (Rx) | None | 0 | None |
NDA 202450, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tudorza Pressair patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10085974 | March 13, 2029 | Drug product | U-2513 | 202450 |
| 11000517 | March 13, 2029 | Drug product | U-2513 | 202450 |
Tudorza Pressair NDC codes
Questions
Is there a generic for Tudorza Pressair?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tudorza Pressair (aclidinium bromide). The Orange Book shows its last listed patent expires March 13, 2029.
What is the generic name for Tudorza Pressair?
The active ingredient in Tudorza Pressair is aclidinium bromide, per the FDA Orange Book.
When does the Tudorza Pressair patent expire?
The last patent listed for Tudorza Pressair in the Orange Book expires March 13, 2029. 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.