FDA Orange Book
Generic for Mirvaso
Mirvaso contains 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
Yes. The generic name for Mirvaso is brimonidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Mirvaso products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | EQ 0.33% BASE | Marketed (Rx) | AB | 1 | AB |
NDA 204708, held by GALDERMA LABORATORIES LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic brimonidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 209158 | AB (A-rated, therapeutically equivalent) | September 23, 2021 | EQ 0.33% BASE |
Mirvaso patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8513247 | March 25, 2031 | Drug product | U-1428 | 204708 |
| 8513249 | March 25, 2031 | Drug product | U-1428 | 204708 |
| 9861631 | March 25, 2031 | Method of use | U-1428 | 204708 |
| 9861632 | March 25, 2031 | Method of use | U-1428 | 204708 |
| 8053427 | June 13, 2031 | Drug product | U-1428 | 204708 |
| 8163725 | June 13, 2031 | Drug product | None | 204708 |
| 10201517 | June 13, 2031 | Drug product | None | 204708 |
Mirvaso NDC codes
Questions
Is there a generic for Mirvaso?
Yes. The generic name for Mirvaso is brimonidine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Mirvaso?
The active ingredient in Mirvaso is brimonidine, per the FDA Orange Book.
When does the Mirvaso patent expire?
The last patent listed for Mirvaso in the Orange Book expires June 13, 2031. 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.