FDA Orange Book
Generic for Subutex
Subutex contains buprenorphine. 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 Subutex is buprenorphine. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Subutex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, sublingual | EQ 2MG BASE | Discontinued | None | 8 | AB |
| tablet, sublingual | EQ 8MG BASE | Discontinued | None | 8 | AB |
NDA 020732, held by INDIVIOR INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic buprenorphine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 078633 | AB (A-rated, therapeutically equivalent) | October 8, 2009 | EQ 2MG BASE, EQ 8MG BASE |
| ETHYPHARM INC | 090622 | AB (A-rated, therapeutically equivalent) | September 24, 2010 | EQ 2MG BASE, EQ 8MG BASE |
| ACTAVIS ELIZABETH LLC | 090819 | AB (A-rated, therapeutically equivalent) | February 19, 2015 | EQ 2MG BASE, EQ 8MG BASE |
| RUBICON RESEARCH LTD | 090279 | AB (A-rated, therapeutically equivalent) | June 10, 2015 | EQ 2MG BASE, EQ 8MG BASE |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 201760 | AB (A-rated, therapeutically equivalent) | January 29, 2016 | EQ 2MG BASE, EQ 8MG BASE |
| RHODES PHARMACEUTICALS LP | 207276 | AB (A-rated, therapeutically equivalent) | March 27, 2017 | EQ 2MG BASE, EQ 8MG BASE |
| SPECGX LLC | 218473 | AB (A-rated, therapeutically equivalent) | December 10, 2025 | EQ 2MG BASE, EQ 8MG BASE |
| ASCENT PHARMACEUTICALS INC | 219401 | AB (A-rated, therapeutically equivalent) | December 18, 2025 | EQ 2MG BASE, EQ 8MG BASE |
Questions
Is there a generic for Subutex?
Yes. The generic name for Subutex is buprenorphine. 8 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 Subutex?
The active ingredient in Subutex is buprenorphine, 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.