FDA Orange Book
Generic for Prezista
Prezista contains darunavir. 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 Prezista is darunavir. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Prezista products the Orange Book lists.
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Prezista products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 100MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 150MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 300MG | Discontinued | None | 1 | None |
| tablet, oral | 400MG | Discontinued | None | 2 | AB |
| tablet, oral | 600MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 75MG | Marketed (Rx) | AB | 1 | AB |
| tablet, oral | 800MG | Marketed (Rx) | AB | 8 | AB |
NDA 202895, 021976, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic darunavir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN LTD | 202073 | AB (A-rated, therapeutically equivalent) | September 29, 2022 | 600MG, 800MG |
| HETERO LABS LTD UNIT III | 202083 | AB (A-rated, therapeutically equivalent) | September 14, 2023 | 400MG, 600MG |
| AUROBINDO PHARMA LTD | 210677 | AB (A-rated, therapeutically equivalent) | November 28, 2023 | 600MG, 800MG |
| CIPLA LTD | 206288 | AB (A-rated, therapeutically equivalent) | November 28, 2023 | 600MG, 800MG |
| DR REDDYS LABORATORIES LTD | 211578 | AB (A-rated, therapeutically equivalent) | November 28, 2023 | 600MG, 800MG |
| MSN LABORATORIES PRIVATE LTD | 215389 | AB (A-rated, therapeutically equivalent) | November 28, 2023 | 600MG, 800MG |
| AMNEAL EU LTD | 212493 | AB (A-rated, therapeutically equivalent) | December 8, 2023 | 600MG, 800MG |
| ZYDUS LIFESCIENCES LTD | 214085 | AB (A-rated, therapeutically equivalent) | December 13, 2023 | 600MG, 800MG |
| ANNORA PHARMA PRIVATE LTD | 216168 | AB (A-rated, therapeutically equivalent) | January 21, 2025 | 600MG, 800MG |
| MYLAN PHARMACEUTICALS INC | 202136 | AB (A-rated, therapeutically equivalent) | July 22, 2025 | 150MG, 300MG, 400MG, 600MG, 75MG |
Prezista patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7700645 | December 26, 2026 | Drug substance, Drug product | None | 202895 |
| 7700645*PED | June 26, 2027 | Method of use | None | 202895 |
Prezista NDC codes
Questions
Is there a generic for Prezista?
Yes. The generic name for Prezista is darunavir. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 6 of the 7 Prezista products the Orange Book lists.
What is the generic name for Prezista?
The active ingredient in Prezista is darunavir, per the FDA Orange Book.
When does the Prezista patent expire?
The last patent listed for Prezista in the Orange Book expires June 26, 2027. 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.