FDA Orange Book · active-ingredient family
Darunavir
Darunavir is approved as 2 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PREZISTA · NDA 202895
2
Brand (NDA)
11
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PREZISTARLD | JANSSEN PRODS | NDA 202895 | — | Dec 16, 2011 | |
| PREZISTARLD×6 | JANSSEN PRODS | NDA 021976 | AB | Dec 18, 2008 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DARUNAVIR×5 | MYLAN | ANDA 202136 | AB | Jul 22, 2025 | |
| DARUNAVIR×2 | ANNORA PHARMA | ANDA 216168 | AB | Jan 21, 2025 | |
| DARUNAVIR×2 | ZYDUS LIFESCIENCES | ANDA 214085 | AB | Dec 13, 2023 | |
| DARUNAVIR×2 | AMNEAL | ANDA 212493 | AB | Dec 08, 2023 | |
| DARUNAVIR×2 | AUROBINDO PHARMA LTD | ANDA 210677 | AB | Nov 28, 2023 | |
| DARUNAVIR×2 | CIPLA | ANDA 206288 | AB | Nov 28, 2023 | |
| DARUNAVIR×2 | DR REDDYS | ANDA 211578 | AB | Nov 28, 2023 | |
| DARUNAVIR×2 | MSN | ANDA 215389 | AB | Nov 28, 2023 | |
| DARUNAVIR×2 | HETERO LABS LTD III | ANDA 202083 | AB | Sep 14, 2023 | |
| DARUNAVIR×2 | LUPIN | ANDA 202073 | AB | Sep 29, 2022 | |
| DARUNAVIR | TEVA PHARMS USA | ANDA 202118 | — | Nov 21, 2017 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7700645 | Dec 26, 2026 | in 6 mo | SubstanceProduct |
| 7700645*PED | Jun 26, 2027 | in 1 yr |
Darunavir — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
