FDA Orange Book
Is there a generic for TOBI Podhaler?
TOBI Podhaler contains tobramycin. 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 TOBI Podhaler (tobramycin). The Orange Book shows its last listed patent expires November 4, 2030.
Run it in Rivvi
Map TOBI Podhaler and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
TOBI Podhaler products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, inhalation | 28MG | Marketed (Rx) | None | 0 | None |
NDA 201688, held by VIATRIS SPECIALTY LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
TOBI Podhaler patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8869794 | September 12, 2028 | Drug product | U-909 | 201688 |
| 10207066 | November 4, 2030 | Drug product | U-909 | 201688 |
TOBI Podhaler NDC codes
Questions
Is there a generic for TOBI Podhaler?
No. The Orange Book lists no active FDA-approved generic (ANDA) for TOBI Podhaler (tobramycin). The Orange Book shows its last listed patent expires November 4, 2030.
What is the generic name for TOBI Podhaler?
The active ingredient in TOBI Podhaler is tobramycin, per the FDA Orange Book.
When does the TOBI Podhaler patent expire?
The last patent listed for TOBI Podhaler in the Orange Book expires November 4, 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.
More on TOBI Podhaler and Tobramycin
- What is Tobramycin used for?FDA label uses
- Is Tobramycin a controlled substance?Federal schedule
- Generic for NebcinFDA Orange Book
- Generic for TobrexFDA Orange Book
- Generic for BethkisFDA Orange Book
- Generic for Kitabis PakFDA Orange Book
- Generic for TobiFDA Orange Book
- Aminoglycoside Antibacterials listFDA drug class
- NDC 49502-401TOBI Podhaler NDC record