FDA Orange Book
Is there a generic for Amzeeq?
Amzeeq 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 Amzeeq (minocycline). The Orange Book shows its last listed patent expires September 8, 2037.
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Amzeeq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| aerosol, foam, topical | EQ 4% BASE | Marketed (Rx) | None | 0 | None |
NDA 212379, 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.
Amzeeq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10137200 | October 1, 2030 | Method of use | U-2647 | 212379 |
| 8865139 | October 1, 2030 | Drug product | U-2647 | 212379 |
| 9675700 | October 1, 2030 | Drug product | U-2647 | 212379 |
| 8992896 | October 1, 2030 | Drug product | U-2647 | 212379 |
| 10086080 | October 1, 2030 | Method of use | U-2647 | 212379 |
| 10213512 | October 1, 2030 | Drug product | U-2647 | 212379 |
| 10517882 | October 1, 2030 | Method of use | U-2647 | 212379 |
| 10821187 | October 1, 2030 | Method of use | U-2647 | 212379 |
| 8945516 | October 1, 2030 | Drug product | None | 212379 |
| 10265404 | October 1, 2030 | Drug product | None | 212379 |
| 10398641 | September 8, 2037 | Method of use | U-2647 | 212379 |
| 10849847 | September 8, 2037 | Method of use | U-2647 | 212379 |
Amzeeq NDC codes
Questions
Is there a generic for Amzeeq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Amzeeq (minocycline). The Orange Book shows its last listed patent expires September 8, 2037.
What is the generic name for Amzeeq?
The active ingredient in Amzeeq is minocycline, per the FDA Orange Book.
When does the Amzeeq patent expire?
The last patent listed for Amzeeq in the Orange Book expires September 8, 2037. 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 Amzeeq and Minocycline
- What is Minocycline used for?FDA label uses
- Is Minocycline a controlled substance?Federal schedule
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- Tetracycline-class Drugs listFDA drug class
- NDC 69489-201Amzeeq NDC record