FDA Orange Book
Generic for Buprenex
Buprenex 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 Buprenex is buprenorphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Buprenex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 0.3MG BASE/ML | Discontinued | None | 4 | AP |
NDA 018401, 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 |
|---|---|---|---|---|
| HOSPIRA INC | 074137 | AP (A-rated, therapeutically equivalent) | June 3, 1996 | EQ 0.3MG BASE/ML |
| HIKMA PHARMACEUTICALS USA INC | 076931 | AP (A-rated, therapeutically equivalent) | March 2, 2005 | EQ 0.3MG BASE/ML |
| PH HEALTH LTD | 206586 | AP (A-rated, therapeutically equivalent) | July 28, 2015 | EQ 0.3MG BASE/ML |
| SOMERSET THERAPEUTICS LLC | 219302 | AP (A-rated, therapeutically equivalent) | January 30, 2025 | EQ 0.3MG BASE/ML |
Questions
Is there a generic for Buprenex?
Yes. The generic name for Buprenex is buprenorphine. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Buprenex?
The active ingredient in Buprenex 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.