FDA Orange Book

Generic for Minolira

Minolira 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

Yes. The generic name for Minolira is minocycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Minolira products in the Orange Book

Minolira products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, extended release, oralEQ 105MG BASEDiscontinuedNone2AB
tablet, extended release, oralEQ 135MG BASEDiscontinuedNone4AB

NDA 209269, held by EPI HEALTH LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic minocycline

Approved generic versions of Minolira
CompanyANDATE codeApprovedStrengths
SANDOZ INC090422AB (A-rated, therapeutically equivalent)August 13, 2009EQ 135MG BASE
LUPIN LTD091424AB (A-rated, therapeutically equivalent)November 30, 2011EQ 135MG BASE
AUROBINDO PHARMA LTD202261AB (A-rated, therapeutically equivalent)June 13, 2016EQ 105MG BASE, EQ 135MG BASE
ALKEM LABORATORIES LTD204453AB (A-rated, therapeutically equivalent)September 28, 2016EQ 105MG BASE, EQ 135MG BASE

Minolira patents

Patents listed for Minolira
PatentExpiresCoversUse codeNDA
11103517April 7, 2036Drug productNone209269

Questions

Is there a generic for Minolira?

Yes. The generic name for Minolira is minocycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Minolira?

The active ingredient in Minolira is minocycline, per the FDA Orange Book.

When does the Minolira patent expire?

The last patent listed for Minolira in the Orange Book expires April 7, 2036. 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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