FDA Orange Book
Is there a generic for Emrosi?
Emrosi 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 Emrosi (minocycline). The Orange Book shows its last listed patent expires January 7, 2039 and its last listed exclusivity ends November 1, 2027.
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Emrosi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219015, 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.
Emrosi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11364212 | January 7, 2039 | Method of use | U-4043 | 219015 |
| 11191740 | January 7, 2039 | Method of use | U-4043 | 219015 |
| 10905664 | January 7, 2039 | Method of use | U-4043 | 219015 |
| 12594252 | January 7, 2039 | Method of use | U-4043 | 219015 |
Emrosi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | November 1, 2027 | 219015 |
Emrosi NDC codes
Questions
Is there a generic for Emrosi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Emrosi (minocycline). The Orange Book shows its last listed patent expires January 7, 2039 and its last listed exclusivity ends November 1, 2027.
What is the generic name for Emrosi?
The active ingredient in Emrosi is minocycline, per the FDA Orange Book.
When does the Emrosi patent expire?
The last patent listed for Emrosi in the Orange Book expires January 7, 2039. 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 Emrosi and Minocycline
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