FDA Orange Book
Generic for Doryx
Doryx contains doxycycline. 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 Doryx is doxycycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 8 Doryx products the Orange Book lists.
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Doryx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, delayed release, oral | EQ 100MG BASE | Discontinued | None | 0 | None |
| capsule, delayed release, oral | EQ 75MG BASE | Discontinued | None | 0 | None |
| tablet, delayed release, oral | EQ 100MG BASE | Discontinued | None | 3 | AB |
| tablet, delayed release, oral | EQ 150MG BASE | Discontinued | None | 3 | AB |
| tablet, delayed release, oral | EQ 200MG BASE | Discontinued | None | 4 | AB |
| tablet, delayed release, oral | EQ 50MG BASE | Discontinued | None | 2 | AB |
| tablet, delayed release, oral | EQ 75MG BASE | Discontinued | None | 3 | AB |
| tablet, delayed release, oral | EQ 80MG BASE | Discontinued | None | 0 | None |
NDA 050582, 050795, held by MAYNE PHARMA INTERNATIONAL PTY LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxycycline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 090134 | AB (A-rated, therapeutically equivalent) | December 14, 2011 | EQ 100MG BASE, EQ 200MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 200856 | AB (A-rated, therapeutically equivalent) | April 30, 2013 | EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 75MG BASE |
| PRINSTON PHARMACEUTICAL INC | 207494 | AB (A-rated, therapeutically equivalent) | November 15, 2016 | EQ 150MG BASE, EQ 200MG BASE, EQ 50MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 213075 | AB (A-rated, therapeutically equivalent) | January 3, 2022 | EQ 100MG BASE, EQ 150MG BASE, EQ 200MG BASE, EQ 75MG BASE |
Doryx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8715724 | February 3, 2028 | Drug product | None | 050795 |
Doryx NDC codes
Questions
Is there a generic for Doryx?
Yes. The generic name for Doryx is doxycycline. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 5 of the 8 Doryx products the Orange Book lists.
What is the generic name for Doryx?
The active ingredient in Doryx is doxycycline, per the FDA Orange Book.
When does the Doryx patent expire?
The last patent listed for Doryx in the Orange Book expires February 3, 2028. 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.