FDA Orange Book
Generic for Atripla
Atripla contains efavirenz, emtricitabine and tenofovir disoproxil. 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 Atripla is efavirenz, emtricitabine and tenofovir disoproxil. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Atripla 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.
Atripla products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 600MG;200MG;300MG | Discontinued | None | 6 | AB |
NDA 021937, held by GILEAD SCIENCES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic efavirenz, emtricitabine and tenofovir disoproxil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 203041 | AB (A-rated, therapeutically equivalent) | September 4, 2018 | 600MG;200MG;300MG |
| TEVA PHARMACEUTICALS USA | 091215 | AB (A-rated, therapeutically equivalent) | November 9, 2018 | 600MG;200MG;300MG |
| CIPLA LTD | 206894 | AB (A-rated, therapeutically equivalent) | June 3, 2019 | 600MG;200MG;300MG |
| MACLEODS PHARMACEUTICALS LTD | 204287 | AB (A-rated, therapeutically equivalent) | September 13, 2021 | 600MG;200MG;300MG |
| LAURUS LABS LTD | 213541 | AB (A-rated, therapeutically equivalent) | December 22, 2021 | 600MG;200MG;300MG |
| HETERO LABS LTD UNIT V | 203053 | AB (A-rated, therapeutically equivalent) | January 24, 2022 | 600MG;200MG;300MG |
Atripla patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9018192 | June 13, 2026 | Method of use | U-750 | 021937 |
| 9545414 | June 13, 2026 | Drug product | U-1170 | 021937 |
| 9545414 | June 13, 2026 | Drug product | U-750 | 021937 |
| 9018192 | June 13, 2026 | Method of use | U-1170 | 021937 |
| 8598185 | April 28, 2029 | Drug product | None | 021937 |
Questions
Is there a generic for Atripla?
Yes. The generic name for Atripla is efavirenz, emtricitabine and tenofovir disoproxil. 6 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 Atripla?
The active ingredient in Atripla is efavirenz, emtricitabine and tenofovir disoproxil, per the FDA Orange Book.
When does the Atripla patent expire?
The last patent listed for Atripla in the Orange Book expires April 28, 2029. A listed patent expiry date is not a generic launch date.
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.