Prezista(darunavir)
Darunavir, Prezcobix, Prezista, Rezolsta, Symtuza (darunavir) is a small molecule pharmaceutical. Darunavir was first approved as Prezista on 2006-06-23. It is used to treat acquired immunodeficiency syndrome in the USA. It has been approved in Europe to treat HIV infections.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Darunavir, Prezista (discontinued: Prezista)
CombinationsPrezcobix, Symtuza
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cobicistat
+
Darunavir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PREZCOBIX | Johnson & Johnson | N-205395 RX | 2015-01-29 | 1 products, RLD, RS |
Darunavir
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PREZISTA | Johnson & Johnson | N-021976 RX | 2008-02-25 | 4 products, RLD |
| PREZISTA | Johnson & Johnson | N-202895 RX | 2011-12-16 | 1 products, RLD, RS |
Show 1 discontinued
Cobicistat
+
Darunavir
+
Emtricitabine
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SYMTUZA | Johnson & Johnson | N-210455 RX | 2018-07-17 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darunavir | ANDA | 2024-06-22 |
| darunavir 600 and 800 mg | ANDA | 2024-01-18 |
| prezcobix | New Drug Application | 2024-07-23 |
| prezista | New Drug Application | 2024-07-23 |
| symtuza | New Drug Application | 2024-07-23 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cobicistat / Darunavir / Emtricitabine / Tenofovir Alafenamide Fumarate, Symtuza, Janssen Prods | |||
| 10786518 | 2038-07-19 | U-2978 | |
| 8754065 | 2032-08-15 | DS, DP | U-2352, U-2765 |
| 9296769 | 2032-08-15 | DS, DP | U-2352, U-2765 |
| 7390791 | 2025-04-17 | DS, DP | |
| Cobicistat / Darunavir, Prezcobix, Janssen Prods | |||
| 10039718 | 2032-10-06 | DP | |
| 8148374 | 2029-09-03 | DS, DP | U-1279, U-2353, U-2364, U-2365, U-2766, U-2767, U-2768, U-2939 |
| 7700645 | 2026-12-26 | DS, DP | |
| 8518987 | 2024-02-16 | DS, DP | |
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AE: Protease inhibitors, direct acting antivirals
— J05AE10: Darunavir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR14: Darunavir and cobicistat
— J05AR22: Emtricitabine, tenofovir alafenamide, darunavir and cobicistat
— J05AR26: Darunavir and ritonavir
HCPCS
No data
Clinical
Clinical Trials
282 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 22 | 43 | 57 | 39 | 32 | 182 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 7 | 14 | 21 | 9 | 13 | 59 |
| Hiv | D006678 | — | — | 11 | 7 | 14 | 17 | 6 | 54 |
| Infections | D007239 | EFO_0000544 | — | 6 | 10 | 9 | 10 | 4 | 37 |
| Hiv-1 | D015497 | — | — | 4 | 8 | 9 | 4 | 1 | 25 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 8 | 13 | 1 | 4 | 24 |
| Healthy volunteers/patients | — | — | — | 18 | — | — | 3 | — | 21 |
| Communicable diseases | D003141 | — | — | 1 | 6 | 6 | 5 | 1 | 17 |
| Hepatitis c | D006526 | — | B19.2 | 4 | 4 | 1 | 1 | 1 | 9 |
| Covid-19 | D000086382 | — | — | — | 3 | 3 | 1 | 2 | 8 |
Show 33 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv-2 | D015498 | — | — | 1 | 1 | 1 | — | 3 | 6 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | 1 | — | 2 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 2 | 1 | — | — | 2 |
| Fibrosis | D005355 | — | — | — | 2 | 1 | — | — | 2 |
| Virus diseases | D014777 | — | B34 | — | 2 | 1 | — | — | 2 |
| Coronavirus | D017934 | — | — | — | — | 1 | — | 1 | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 1 | 1 | — | — | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 1 | — | — | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | 2 | — | — | — | 2 |
| Sars-cov-2 | D000086402 | — | — | — | 2 | — | — | — | 2 |
| Contraception | D003267 | — | — | — | 2 | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | — | — | — | 1 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | 1 | 4 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | — | — | — | 1 | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Hyperlipoproteinemias | D006951 | HP_0010980 | — | 1 | — | — | — | — | 1 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 1 | — | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | — | — | 1 | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 1 | 1 |
| Morbidity | D009017 | — | — | — | — | — | — | 1 | 1 |
| Therapeutic equivalency | D013810 | — | — | — | — | — | — | 1 | 1 |
| Dementia | D003704 | EFO_0003862 | F03 | — | — | — | — | 1 | 1 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 1 | 1 |
| Radius fractures | D011885 | EFO_0003957 | — | — | — | — | — | 1 | 1 |
| Wrist fractures | D000092503 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Darunavir |
| INN | darunavir |
| Description | Darunavir is an N,N-disubstituted benzenesulfonamide bearing an unsubstituted amino group at the 4-position, used for the treatment of HIV infection. A second-generation HIV protease inhibitor, darunavir was designed to form robust interactions with the protease enzyme from many strains of HIV, including those from treatment-experienced patients with multiple resistance mutations to other protease inhibitors. It has a role as a HIV protease inhibitor and an antiviral drug. It is a furofuran, a carbamate ester and a sulfonamide. |
| Classification | Small molecule |
| Drug class | antivirals: HIV protease inhibitors (saquinavir type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)CN(C[C@@H](O)[C@H](Cc1ccccc1)NC(=O)O[C@H]1CO[C@H]2OCC[C@@H]12)S(=O)(=O)c1ccc(N)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 206361-99-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1323 |
| ChEBI ID | 367163 |
| PubChem CID | 213039 |
| DrugBank | DB01264 |
| UNII ID | YO603Y8113 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Darunavir
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 11,521 documents
View more details
Safety
Black-box Warning
Black-box warning for: Symtuza
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
15,265 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use