FDA Orange Book
Generic for Tenex
Tenex contains guanfacine. 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 Tenex is guanfacine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Tenex products the Orange Book lists.
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Tenex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1MG BASE | Discontinued | None | 11 | AB |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 11 | AB |
| tablet, oral | EQ 3MG BASE | Discontinued | None | 0 | None |
NDA 019032, held by PROMIUS PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic guanfacine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 074145 | AB (A-rated, therapeutically equivalent) | October 17, 1995 | EQ 1MG BASE, EQ 2MG BASE |
| AUROBINDO PHARMA USA INC | 074796 | AB (A-rated, therapeutically equivalent) | January 27, 1997 | EQ 1MG BASE, EQ 2MG BASE |
| EPIC PHARMA LLC | 074673 | AB (A-rated, therapeutically equivalent) | February 28, 1997 | EQ 1MG BASE, EQ 2MG BASE |
| AMNEAL PHARMACEUTICAL | 075109 | AB (A-rated, therapeutically equivalent) | November 25, 1998 | EQ 1MG BASE, EQ 2MG BASE |
| UNICHEM LABORATORIES LTD | 214689 | AB (A-rated, therapeutically equivalent) | March 3, 2021 | EQ 1MG BASE, EQ 2MG BASE |
| AIPING PHARMACEUTICAL INC | 216399 | AB (A-rated, therapeutically equivalent) | June 8, 2022 | EQ 1MG BASE, EQ 2MG BASE |
| AJANTA PHARMA LTD | 217293 | AB (A-rated, therapeutically equivalent) | April 27, 2023 | EQ 1MG BASE, EQ 2MG BASE |
| PHARMAZONE | 216828 | AB (A-rated, therapeutically equivalent) | October 5, 2023 | EQ 1MG BASE, EQ 2MG BASE |
| RUBICON RESEARCH LTD | 216762 | AB (A-rated, therapeutically equivalent) | October 17, 2023 | EQ 1MG BASE, EQ 2MG BASE |
| XIROMED PHARMA ESPANA SL | 218326 | AB (A-rated, therapeutically equivalent) | February 23, 2024 | EQ 1MG BASE, EQ 2MG BASE |
| ASCENT PHARMACEUTICALS INC | 220675 | AB (A-rated, therapeutically equivalent) | March 24, 2026 | EQ 1MG BASE, EQ 2MG BASE |
Questions
Is there a generic for Tenex?
Yes. The generic name for Tenex is guanfacine. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Tenex products the Orange Book lists.
What is the generic name for Tenex?
The active ingredient in Tenex is guanfacine, 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.