FDA Orange Book
Generic for Sinequan
Sinequan contains doxepin. 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 Sinequan is doxepin. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
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Sinequan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 15 | AB, BX |
| capsule, oral | EQ 10MG BASE | Discontinued | None | 15 | AB, BX |
| capsule, oral | EQ 150MG BASE | Discontinued | None | 2 | AB, BX |
| capsule, oral | EQ 25MG BASE | Discontinued | None | 15 | AB, BX |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 15 | AB, BX |
| capsule, oral | EQ 75MG BASE | Discontinued | None | 15 | AB, BX |
| concentrate, oral | EQ 10MG BASE/ML | Discontinued | None | 1 | None |
NDA 016798, 017516, held by PFIZER LABORATORIES DIV PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxepin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 070791 | AB (A-rated, therapeutically equivalent) | May 13, 1986 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| LANNETT CO INC | 074721 | None (No TE code listed) | December 29, 1998 | EQ 10MG BASE/ML |
| AMNEAL PHARMACEUTICALS CO GMBH | 207482 | AB (A-rated, therapeutically equivalent) | June 28, 2017 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| AUROBINDO PHARMA LTD | 211603 | AB (A-rated, therapeutically equivalent) | March 27, 2019 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| AJANTA PHARMA LTD | 212624 | AB (A-rated, therapeutically equivalent) | September 13, 2019 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| AIPING PHARMACEUTICAL INC | 213474 | AB (A-rated, therapeutically equivalent) | July 28, 2020 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| CHARTWELL RX SCIENCES LLC | 210268 | AB (A-rated, therapeutically equivalent) | September 4, 2020 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| EPIC PHARMA LLC | 210675 | AB (A-rated, therapeutically equivalent) | October 16, 2020 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| VELZEN PHARMA PVT LTD | 211618 | AB (A-rated, therapeutically equivalent) | March 1, 2021 | EQ 150MG BASE |
| LEADING PHARMA LLC | 211619 | AB (A-rated, therapeutically equivalent) | March 9, 2021 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| APPCO PHARMA LLC | 214908 | AB (A-rated, therapeutically equivalent) | April 1, 2021 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 215076 | AB (A-rated, therapeutically equivalent) | April 21, 2021 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| MANKIND PHARMA LTD | 215710 | AB (A-rated, therapeutically equivalent) | February 9, 2022 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| JUBILANT CADISTA PHARMACEUTICALS INC | 215483 | AB (A-rated, therapeutically equivalent) | March 14, 2022 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| MSN LABORATORIES PRIVATE LTD | 215113 | AB (A-rated, therapeutically equivalent) | June 24, 2022 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| ZYDUS LIFESCIENCES LTD | 210140 | BX (B-rated, not considered equivalent) | March 21, 2023 | EQ 150MG BASE |
| ZYDUS LIFESCIENCES LTD | 210700 | BX (B-rated, not considered equivalent) | March 23, 2023 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
| UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD | 217975 | AB (A-rated, therapeutically equivalent) | August 21, 2023 | EQ 100MG BASE, EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE |
Questions
Is there a generic for Sinequan?
Yes. The generic name for Sinequan is doxepin. 17 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX.
What is the generic name for Sinequan?
The active ingredient in Sinequan is doxepin, per the FDA Orange Book.
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.