FDA Orange Book
Generic for Minocin
Minocin 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 Minocin is minocycline. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 7 Minocin products the Orange Book lists.
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Minocin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | EQ 100MG BASE | Discontinued | None | 5 | AB |
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | AB | 5 | AB |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 5 | AB |
| capsule, oral | EQ 75MG BASE | Discontinued | None | 5 | AB |
| injectable, injection | EQ 100MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
| suspension, oral | EQ 50MG BASE/5ML | Discontinued | None | 0 | None |
NDA 050649, 050315, 050444, 050445, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic minocycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 063065 | AB (A-rated, therapeutically equivalent) | December 30, 1991 | EQ 100MG BASE, EQ 100MG BASE, EQ 75MG BASE |
| WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 063181 | AB (A-rated, therapeutically equivalent) | December 30, 1991 | EQ 50MG BASE, EQ 50MG BASE |
| ZYDUS WORLDWIDE DMCC | 063009 | AB (A-rated, therapeutically equivalent) | March 2, 1992 | EQ 100MG BASE, EQ 100MG BASE, EQ 75MG BASE |
| ZYDUS WORLDWIDE DMCC | 063011 | AB (A-rated, therapeutically equivalent) | March 2, 1992 | EQ 50MG BASE, EQ 50MG BASE |
| IMPAX LABORATORIES INC | 065005 | AB (A-rated, therapeutically equivalent) | March 23, 1999 | EQ 100MG BASE, EQ 100MG BASE, EQ 50MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| TORRENT PHARMACEUTICALS LTD | 065062 | AB (A-rated, therapeutically equivalent) | November 30, 2000 | EQ 100MG BASE, EQ 100MG BASE, EQ 50MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| AUROBINDO PHARMA LTD | 065470 | AB (A-rated, therapeutically equivalent) | March 11, 2008 | EQ 100MG BASE, EQ 100MG BASE, EQ 50MG BASE, EQ 50MG BASE, EQ 75MG BASE |
Minocin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9084802 | May 12, 2031 | Method of use | U-282 | 050444 |
| 9278105 | May 12, 2031 | Method of use | U-282 | 050444 |
| 12161656 | May 12, 2031 | Drug product | None | 050444 |
| 11944634 | October 16, 2032 | Drug product | None | 050444 |
Minocin NDC codes
Questions
Is there a generic for Minocin?
Yes. The generic name for Minocin is minocycline. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 7 Minocin products the Orange Book lists.
What is the generic name for Minocin?
The active ingredient in Minocin is minocycline, per the FDA Orange Book.
When does the Minocin patent expire?
The last patent listed for Minocin in the Orange Book expires October 16, 2032. 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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