Edurant, Eviplera(rilpivirine)
Cabenuva, Complera, Edurant, Eviplera, Juluca, Odefsey, Rekambys (rilpivirine) is a small molecule pharmaceutical. Rilpivirine was first approved as Edurant on 2011-05-20. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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FDA Novel Drug Approvals 2021
Top 200 Pharmaceuticals by Retail Sales
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
infections | D007239 |
urogenital diseases | D000091642 |
immune system diseases | D007154 |
Trade Name
FDA
EMA
Edurant
CombinationsCabenuva, Complera, Juluca, Odefsey
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cabotegravir
+
Rilpivirine
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
CABENUVA KIT | ViiV Healthcare | N-212888 RX | 2021-01-21 | 2 products, RLD, RS |
Dolutegravir sodium
+
Rilpivirine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
JULUCA | ViiV Healthcare | N-210192 RX | 2017-11-21 | 1 products, RLD, RS |
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ODEFSEY | Gilead Sciences | N-208351 RX | 2016-03-01 | 1 products, RLD, RS |
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir disoproxil fumarate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
COMPLERA | Gilead Sciences | N-202123 RX | 2011-08-10 | 1 products, RLD, RS |
Rilpivirine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
EDURANT | Johnson & Johnson | N-202022 RX | 2011-05-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
cabenuva | New Drug Application | 2021-01-21 |
complera access | Export only | 2021-03-29 |
edurant | New Drug Application | 2021-02-02 |
juluca | New Drug Application | 2021-07-09 |
odefsey | New Drug Application | 2021-09-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
CABOTEGRAVIR / RILPIVIRINE, CABENUVA KIT, VIIV HLTHCARE | |||
2026-01-21 | NCE | ||
2025-03-29 | NPP | ||
2025-01-31 | D-184 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate, Complera, Gilead Sciences Inc | |||
10857102 | 2033-01-14 | DP | |
8841310 | 2025-12-09 | DP | U-257 |
8592397 | 2024-01-13 | DP | U-257 |
8716264 | 2024-01-13 | DP | U-257 |
9457036 | 2024-01-13 | DP | U-257 |
9744181 | 2024-01-13 | DP | U-257 |
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc | |||
8754065 | 2032-08-15 | DS, DP | U-257 |
9296769 | 2032-08-15 | DS, DP | U-257 |
7390791 | 2025-04-17 | DS, DP | |
Cabotegravir / Rilpivirine, Cabenuva Kit, Viiv Hlthcare | |||
11224597 | 2031-09-15 | DP | U-3348 |
11389447 | 2027-06-30 | U-3405 | |
8410103 | 2026-04-28 | DS, DP | U-3348 |
10927129 | 2026-04-28 | DS, DP | |
7125879 | 2025-04-21 | DS, DP | U-257, U-1153, U-1307, U-1740, U-3348, U-3353 |
8080551 | 2023-04-11 | DS, DP | |
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare | |||
10426780 | 2031-01-24 | DS, DP | U-257 |
9242986 | 2029-12-08 | DS, DP | |
8129385 | 2027-10-05 | DS, DP | |
Rilpivirine Hydrochloride, Edurant, Janssen Prods | |||
7638522 | 2023-04-14 | DP |
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AG: Non-nucleoside reverse transcriptase inhibitors
— J05AG05: Rilpivirine
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR08: Emtricitabine, tenofovir disoproxil and rilpivirine
— J05AR19: Emtricitabine, tenofovir alafenamide and rilpivirine
— J05AR21: Dolutegravir and rilpivirine
HCPCS
Code | Description |
---|---|
J0741 | Injection, cabotegravir and rilpivirine, 2mg/3mg |
Clinical
Clinical Trials
89 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv infections | D015658 | EFO_0000764 | B20 | 10 | 7 | 11 | 4 | 8 | 36 |
Hiv | D006678 | O98.7 | 7 | 4 | 5 | 3 | 2 | 19 | |
Hiv-1 | D015497 | 3 | 3 | 2 | 1 | — | 9 | ||
Healthy volunteers/patients | — | 6 | — | — | 2 | — | 8 | ||
Cognitive dysfunction | D060825 | G31.84 | — | — | — | 1 | — | 1 | |
Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 1 | — | 1 |
Patient compliance | D010349 | — | — | — | 1 | — | 1 | ||
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infections | D007239 | EFO_0000544 | 1 | 2 | 1 | — | — | 4 | |
Glycogen storage disease type ii | D006009 | Orphanet_365 | E74.02 | — | — | 1 | — | — | 1 |
Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | 1 | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Dyslipidemias | D050171 | HP_0003119 | — | — | — | — | 1 | 1 | |
Sustained virologic response | D000072230 | — | — | — | — | 1 | 1 | ||
Drug interactions | D004347 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | RILPIVIRINE |
INN | rilpivirine |
Description | Rilpivirine is an aminopyrimidine that is pyrimidine-2,4-diamine in which the amino groups at positions 2 and 4 are substituted by 4-cyanophenyl and 4-[(E)-2-cyanovinyl]-2,6-dimethylphenyl groups respectively. Used for treatment of HIV. It has a role as a HIV-1 reverse transcriptase inhibitor and an EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor. It is a nitrile and an aminopyrimidine. It is a conjugate base of a rilpivirine(1+). |
Classification | Small molecule |
Drug class | antivirals: non-nucleoside reverse transcriptase inhibitors, not benzoxazinone derivatives |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | Cc1cc(/C=C/C#N)cc(C)c1Nc1ccnc(Nc2ccc(C#N)cc2)n1 |
Identifiers
PDB | — |
CAS-ID | 500287-72-9 |
RxCUI | 1102270 |
ChEMBL ID | CHEMBL175691 |
ChEBI ID | 68606 |
PubChem CID | 6451164 |
DrugBank | DB08864 |
UNII ID | FI96A8X663 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Edurant - Johnson & Johnson
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Complera - Gilead Sciences
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Odefsey - Gilead Sciences
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,557 documents
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Safety
Black-box Warning
Black-box warning for: Complera access, Odefsey
Adverse Events
Top Adverse Reactions
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10,399 adverse events reported
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