FDA Orange Book
Is there a generic for Zilxi?
Zilxi contains minocycline. 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 Zilxi (minocycline). The Orange Book shows its last listed patent expires October 1, 2030.
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Zilxi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | EQ 1.5% BASE | Marketed (Rx) | None | 0 | None |
NDA 213690, held by JOURNEY MEDICAL CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zilxi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10213512 | October 1, 2030 | Drug product | U-1631 | 213690 |
| 8992896 | October 1, 2030 | Drug product | U-1631 | 213690 |
| 9675700 | October 1, 2030 | Drug product | U-1631 | 213690 |
| 8865139 | October 1, 2030 | Drug product | U-1631 | 213690 |
| 10322186 | October 1, 2030 | Method of use | U-1631 | 213690 |
| 10946101 | October 1, 2030 | Method of use | U-1631 | 213690 |
| 12138311 | October 1, 2030 | Method of use | U-1631 | 213690 |
| 12661407 | October 1, 2030 | Method of use | U-1631 | 213690 |
| 10265404 | October 1, 2030 | Drug product | None | 213690 |
| 8945516 | October 1, 2030 | Drug product | None | 213690 |
Zilxi NDC codes
Questions
Is there a generic for Zilxi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zilxi (minocycline). The Orange Book shows its last listed patent expires October 1, 2030.
What is the generic name for Zilxi?
The active ingredient in Zilxi is minocycline, per the FDA Orange Book.
When does the Zilxi patent expire?
The last patent listed for Zilxi in the Orange Book expires October 1, 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 Zilxi and Minocycline
- What is Minocycline used for?FDA label uses
- Is Minocycline a controlled substance?Federal schedule
- Generic for AmzeeqFDA Orange Book
- Generic for EmrosiFDA Orange Book
- Generic for MinocinFDA Orange Book
- Generic for ArestinFDA Orange Book
- Generic for MinoliraFDA Orange Book
- Generic for SolodynFDA Orange Book
- Tetracycline-class Drugs listFDA drug class
- NDC 69489-212Zilxi NDC record