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

Emrosi products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
capsule, extended release, oralEQ 40MG BASEMarketed (Rx)None0None

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

Patents listed for Emrosi
PatentExpiresCoversUse codeNDA
11364212January 7, 2039Method of useU-4043219015
11191740January 7, 2039Method of useU-4043219015
10905664January 7, 2039Method of useU-4043219015
12594252January 7, 2039Method of useU-4043219015

Emrosi exclusivity

Exclusivity listed for Emrosi
CodeMeaningExpiresNDA
NPNew productNovember 1, 2027219015

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.

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