FDA Orange Book
Generic for Solodyn
Solodyn 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 Solodyn 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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Solodyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 105MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | EQ 115MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | EQ 135MG BASE | Discontinued | None | 4 | AB |
| tablet, extended release, oral | EQ 45MG BASE | Discontinued | None | 4 | AB |
| tablet, extended release, oral | EQ 55MG BASE | Discontinued | None | 3 | AB |
| tablet, extended release, oral | EQ 65MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | EQ 80MG BASE | Discontinued | None | 2 | AB |
| tablet, extended release, oral | EQ 90MG BASE | Discontinued | None | 4 | AB |
NDA 050808, 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 |
|---|---|---|---|---|
| SANDOZ INC | 090422 | AB (A-rated, therapeutically equivalent) | August 13, 2009 | EQ 135MG BASE, EQ 45MG BASE, EQ 90MG BASE |
| LUPIN LTD | 091424 | AB (A-rated, therapeutically equivalent) | November 30, 2011 | EQ 135MG BASE, EQ 45MG BASE, EQ 55MG BASE, EQ 90MG BASE |
| AUROBINDO PHARMA LTD | 202261 | AB (A-rated, therapeutically equivalent) | June 13, 2016 | EQ 105MG BASE, EQ 115MG BASE, EQ 135MG BASE, EQ 45MG BASE, EQ 55MG BASE, EQ 65MG BASE, EQ 80MG BASE, EQ 90MG BASE |
| ALKEM LABORATORIES LTD | 204453 | AB (A-rated, therapeutically equivalent) | September 28, 2016 | EQ 105MG BASE, EQ 115MG BASE, EQ 135MG BASE, EQ 45MG BASE, EQ 55MG BASE, EQ 65MG BASE, EQ 80MG BASE, EQ 90MG BASE |
Solodyn patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7919483 | March 7, 2027 | Method of use | U-1078 | 050808 |
| 7541347 | April 2, 2027 | Method of use | U-917 | 050808 |
| 7544373 | April 2, 2027 | Drug product | None | 050808 |
| 9192615 | November 17, 2031 | Drug product | None | 050808 |
Questions
Is there a generic for Solodyn?
Yes. The generic name for Solodyn 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 Solodyn?
The active ingredient in Solodyn is minocycline, per the FDA Orange Book.
When does the Solodyn patent expire?
The last patent listed for Solodyn in the Orange Book expires November 17, 2031. 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.