FDA Orange Book
Is there a generic for Simbrinza?
Simbrinza contains brinzolamide and brimonidine. 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 Simbrinza (brinzolamide and brimonidine). The Orange Book shows its last listed patent expires October 30, 2030.
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Simbrinza products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension/drops, ophthalmic | 0.2%;1% | Marketed (Rx) | None | 0 | None |
NDA 204251, held by ALCON LABORATORIES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Simbrinza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9421265 | June 17, 2030 | Drug product | None | 204251 |
| 9044484 | October 30, 2030 | Drug product | None | 204251 |
Simbrinza NDC codes
Questions
Is there a generic for Simbrinza?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Simbrinza (brinzolamide and brimonidine). The Orange Book shows its last listed patent expires October 30, 2030.
What is the generic name for Simbrinza?
The active ingredient in Simbrinza is brinzolamide and brimonidine, per the FDA Orange Book.
When does the Simbrinza patent expire?
The last patent listed for Simbrinza in the Orange Book expires October 30, 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.