FDA Orange Book
Generic for Intuniv
Intuniv 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 Intuniv is guanfacine. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Intuniv products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 1MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 2MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 3MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 4MG BASE | Marketed (Rx) | AB | 10 | AB |
NDA 022037, held by TAKEDA PHARMACEUTICALS USA INC. 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 |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 200881 | AB (A-rated, therapeutically equivalent) | October 5, 2012 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| TEVA PHARMACEUTICALS USA | 201382 | AB (A-rated, therapeutically equivalent) | June 2, 2015 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| TWI PHARMACEUTICALS INC | 201408 | AB (A-rated, therapeutically equivalent) | June 2, 2015 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| SANDOZ INC | 202568 | AB (A-rated, therapeutically equivalent) | June 3, 2015 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| APOTEX INC | 205430 | AB (A-rated, therapeutically equivalent) | July 25, 2018 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 213428 | AB (A-rated, therapeutically equivalent) | November 25, 2020 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 217269 | AB (A-rated, therapeutically equivalent) | August 7, 2023 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD | 217638 | AB (A-rated, therapeutically equivalent) | June 12, 2024 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| UNICHEM LABORATORIES LTD | 219033 | AB (A-rated, therapeutically equivalent) | November 19, 2024 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
| RUBICON RESEARCH LTD | 219689 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE |
Intuniv NDC codes
Questions
Is there a generic for Intuniv?
Yes. The generic name for Intuniv is guanfacine. 10 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 Intuniv?
The active ingredient in Intuniv 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.