FDA Orange Book
Generic for Truvada
Truvada contains 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 Truvada is emtricitabine and tenofovir disoproxil. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Truvada products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG;150MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 133MG;200MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 167MG;250MG | Marketed (Rx) | AB | 4 | AB |
| tablet, oral | 200MG;300MG | Marketed (Rx) | AB | 9 | AB |
NDA 021752, held by GILEAD SCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic emtricitabine and tenofovir disoproxil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 090894 | AB (A-rated, therapeutically equivalent) | June 8, 2017 | 200MG;300MG |
| AUROBINDO PHARMA LTD | 090513 | AB (A-rated, therapeutically equivalent) | January 26, 2018 | 200MG;300MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 209721 | AB (A-rated, therapeutically equivalent) | August 22, 2018 | 100MG;150MG, 133MG;200MG, 167MG;250MG, 200MG;300MG |
| LAURUS LABS LTD | 212114 | AB (A-rated, therapeutically equivalent) | July 26, 2019 | 200MG;300MG |
| MACLEODS PHARMACEUTICALS LTD | 203442 | AB (A-rated, therapeutically equivalent) | May 15, 2020 | 200MG;300MG |
| STRIDES PHARMA GLOBAL PTE LTD | 091055 | AB (A-rated, therapeutically equivalent) | January 13, 2021 | 200MG;300MG |
| CHARTWELL RX SCIENCES LLC | 204131 | AB (A-rated, therapeutically equivalent) | June 4, 2021 | 200MG;300MG |
| ZYDUS PHARMACEUTICALS USA INC | 212689 | AB (A-rated, therapeutically equivalent) | July 1, 2021 | 100MG;150MG, 133MG;200MG, 167MG;250MG, 200MG;300MG |
| AUROBINDO PHARMA LTD | 211640 | AB (A-rated, therapeutically equivalent) | March 9, 2023 | 100MG;150MG, 133MG;200MG, 167MG;250MG |
| HETERO LABS LTD UNIT III | 201806 | AB (A-rated, therapeutically equivalent) | March 3, 2025 | 100MG;150MG, 133MG;200MG, 167MG;250MG, 200MG;300MG |
Truvada NDC codes
Questions
Is there a generic for Truvada?
Yes. The generic name for Truvada is emtricitabine and tenofovir disoproxil. 9 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 Truvada?
The active ingredient in Truvada is emtricitabine and tenofovir disoproxil, 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.
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