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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
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Edurant
Combinations
Cabenuva, 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 KITViiV HealthcareN-212888 RX2021-01-21
2 products, RLD, RS
Dolutegravir sodium
+
Rilpivirine hydrochloride
Tradename
Company
Number
Date
Products
JULUCAViiV HealthcareN-210192 RX2017-11-21
1 products, RLD, RS
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
ODEFSEYGilead SciencesN-208351 RX2016-03-01
1 products, RLD, RS
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
COMPLERAGilead SciencesN-202123 RX2011-08-10
1 products, RLD, RS
Rilpivirine hydrochloride
Tradename
Company
Number
Date
Products
EDURANTJohnson & JohnsonN-202022 RX2011-05-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
cabenuvaNew Drug Application2021-01-21
complera accessExport only2021-03-29
edurantNew Drug Application2021-02-02
julucaNew Drug Application2021-07-09
odefseyNew Drug Application2021-09-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
CABOTEGRAVIR / RILPIVIRINE, CABENUVA KIT, VIIV HLTHCARE
2026-01-21NCE
2025-03-29NPP
2025-01-31D-184
Patent Expiration
Patent
Expires
Flag
FDA Information
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Disoproxil Fumarate, Complera, Gilead Sciences Inc
108571022033-01-14DP
88413102025-12-09DPU-257
85923972024-01-13DPU-257
87162642024-01-13DPU-257
94570362024-01-13DPU-257
97441812024-01-13DPU-257
Emtricitabine / Rilpivirine Hydrochloride / Tenofovir Alafenamide Fumarate, Odefsey, Gilead Sciences Inc
87540652032-08-15DS, DPU-257
92967692032-08-15DS, DPU-257
73907912025-04-17DS, DP
Cabotegravir / Rilpivirine, Cabenuva Kit, Viiv Hlthcare
112245972031-09-15DPU-3348
113894472027-06-30U-3405
84101032026-04-28DS, DPU-3348
109271292026-04-28DS, DP
71258792025-04-21DS, DPU-257, U-1153, U-1307, U-1740, U-3348, U-3353
80805512023-04-11DS, DP
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare
104267802031-01-24DS, DPU-257
92429862029-12-08DS, DP
81293852027-10-05DS, DP
Rilpivirine Hydrochloride, Edurant, Janssen Prods
76385222023-04-14DP
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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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20107114836
HivD006678O98.77453219
Hiv-1D0154973321—9
Healthy volunteers/patients—6——2—8
Cognitive dysfunctionD060825G31.84———1—1
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Patient complianceD010349———1—1
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544121——4
Glycogen storage disease type iiD006009Orphanet_365E74.02——1——1
PregnancyD011247EFO_0002950Z33.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ContraceptionD003267—2——13
Hiv-2D015498—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Acquired immunodeficiency syndromeD000163EFO_0000765B202———13
Hepatitis cD006526B19.21————1
HepacivirusD0161741————1
PharmacokineticsD0105991————1
Biological availabilityD0016821————1
Hepatic insufficiencyD0485501————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DyslipidemiasD050171HP_0003119————11
Sustained virologic responseD000072230————11
Drug interactionsD004347————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRILPIVIRINE
INNrilpivirine
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 classantivirals: 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-ID500287-72-9
RxCUI1102270
ChEMBL IDCHEMBL175691
ChEBI ID68606
PubChem CID6451164
DrugBankDB08864
UNII IDFI96A8X663 (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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