FDA Orange Book
Generic for Sustiva
Sustiva contains efavirenz. 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 Sustiva is efavirenz. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Sustiva products the Orange Book lists.
Run it in Rivvi
Map Sustiva and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Sustiva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 100MG | Discontinued | None | 1 | None |
| capsule, oral | 200MG | Discontinued | None | 1 | None |
| capsule, oral | 50MG | Discontinued | None | 1 | None |
| tablet, oral | 300MG | Discontinued | None | 0 | None |
| tablet, oral | 600MG | Discontinued | None | 4 | AB |
NDA 020972, 021360, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic efavirenz
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 078064 | None (No TE code listed) | December 15, 2017 | 100MG, 200MG, 50MG |
| HETERO LABS LTD UNIT III | 078886 | AB (A-rated, therapeutically equivalent) | April 27, 2018 | 600MG |
| CIPLA LTD | 204766 | AB (A-rated, therapeutically equivalent) | June 15, 2018 | 600MG |
| AUROBINDO PHARMA LTD | 077673 | AB (A-rated, therapeutically equivalent) | September 21, 2018 | 600MG |
| MACLEODS PHARMACEUTICALS LTD | 091579 | AB (A-rated, therapeutically equivalent) | May 10, 2024 | 600MG |
Questions
Is there a generic for Sustiva?
Yes. The generic name for Sustiva is efavirenz. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 5 Sustiva products the Orange Book lists.
What is the generic name for Sustiva?
The active ingredient in Sustiva is efavirenz, 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.