FDA Orange Book
Is there a generic for Tobradex ST?
Tobradex ST contains tobramycin and dexamethasone. 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 Tobradex ST (tobramycin and dexamethasone). The Orange Book shows its last listed patent expires August 3, 2028.
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Tobradex ST products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 0.05%;0.3% | Marketed (Rx) | None | 0 | None |
NDA 050818, held by HARROW EYE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tobradex ST patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8101582 | December 19, 2027 | Drug product | U-1082 | 050818 |
| 8450287 | December 19, 2027 | Drug product | None | 050818 |
| 7795316 | August 3, 2028 | Drug product | U-1082 | 050818 |
Tobradex ST NDC codes
Questions
Is there a generic for Tobradex ST?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tobradex ST (tobramycin and dexamethasone). The Orange Book shows its last listed patent expires August 3, 2028.
What is the generic name for Tobradex ST?
The active ingredient in Tobradex ST is tobramycin and dexamethasone, per the FDA Orange Book.
When does the Tobradex ST patent expire?
The last patent listed for Tobradex ST in the Orange Book expires August 3, 2028. 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 Tobradex ST and Tobramycin and Dexamethasone
- What is Tobradex ST used for?FDA label uses
- Is Tobradex ST a controlled substance?Federal schedule
- What is Tobramycin and Dexamethasone used for?FDA label uses
- Is Tobramycin and Dexamethasone a controlled substance?Federal schedule
- Generic for TobraDexFDA Orange Book
- Aminoglycoside Antibacterials listFDA drug class
- Corticosteroids listFDA drug class
- NDC 71776-035Tobradex ST NDC record
- NDC 82667-011Tobradex ST NDC record