FDA Orange Book
Generic for Kapvay
Kapvay contains clonidine. 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 Kapvay is clonidine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1. Generics match 1 of the 2 Kapvay products the Orange Book lists.
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Kapvay products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 0.1MG | Discontinued | None | 7 | AB1 |
| tablet, extended release, oral | 0.2MG | Discontinued | None | 0 | None |
NDA 022331, held by CONCORDIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clonidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 203320 | AB1 (A-rated, therapeutically equivalent) | May 15, 2015 | 0.1MG |
| CHARTWELL RX SCIENCES LLC | 209285 | AB1 (A-rated, therapeutically equivalent) | October 23, 2017 | 0.1MG |
| AJANTA PHARMA LTD | 209686 | AB1 (A-rated, therapeutically equivalent) | November 20, 2017 | 0.1MG |
| XIAMEN LP PHARMACUETICAL CO LTD | 209757 | AB1 (A-rated, therapeutically equivalent) | November 20, 2017 | 0.1MG |
| JUBILANT GENERICS LTD | 210338 | AB1 (A-rated, therapeutically equivalent) | January 29, 2018 | 0.1MG |
| SOMERSET THERAPEUTICS LLC | 211433 | AB1 (A-rated, therapeutically equivalent) | October 12, 2018 | 0.1MG |
| NOVAST LABORATORIES LTD | 209675 | AB1 (A-rated, therapeutically equivalent) | March 5, 2019 | 0.1MG |
Questions
Is there a generic for Kapvay?
Yes. The generic name for Kapvay is clonidine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB1. Generics match 1 of the 2 Kapvay products the Orange Book lists.
What is the generic name for Kapvay?
The active ingredient in Kapvay is clonidine, 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.