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Drug ReportsRilpivirine
Edurant(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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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
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Edurant, Edurant ped
Combinations
Cabenuva, Complera, Emtricitabine, rilpivirine tenofovir disoproxil, Juluca, Odefsey
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rilpivirine hydrochloride
Tradename
Company
Number
Date
Products
EDURANTJohnson & JohnsonN-202022 RX2011-05-20
1 products, RLD, RS
EDURANT PEDJohnson & JohnsonN-219016 RX2024-03-15
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
Emtricitabine
+
Rilpivirine hydrochloride
+
Tenofovir alafenamide fumarate
Tradename
Company
Number
Date
Products
ODEFSEYGilead SciencesN-208351 RX2016-03-01
1 products, RLD, RS
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
Labels
FDA
EMA
Brand Name
Status
Last Update
cabenuvaNew Drug Application2025-06-04
compleraNew Drug Application2025-07-16
complera accessExport only2025-07-16
edurantNew Drug Application2022-11-02
edurant edurant pedNew Drug Application2025-08-28
emtricitabine, rilpivirine, tenofovir disoproxil fumarateANDA2024-12-14
julucaNew Drug Application2024-04-18
odefseyNew Drug Application2025-02-24
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
hiv—D006678O98.7
chronic hepatitis bEFO_0004239D019694B18.1
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
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare
104267802031-01-24DS, DPU-257
92429862029-12-08DS, DP
81293852027-10-05DS, 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
175 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 infectionsD015658EFO_0000764B202218451226113
HivD006678—O98.785831436
Acquired immunodeficiency syndromeD000163EFO_0000765B2097111835
Hiv-1D015497——3341—11
Healthy volunteers/patients———7——2—9
Cognitive dysfunctionD060825—G31.84———3—3
Hiv seropositivityD006679—————123
Cardiovascular diseasesD002318EFO_0000319I98———2—2
Neurocognitive disordersD019965—F09———1—1
Anxiety disordersD001008EFO_0006788F41.1———1—1
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—436—215
Communicable diseasesD003141——135—211
Hepatitis cD006526—B19.23—3—17
Immunologic deficiency syndromesD007153—D84.9—23—27
Chronic hepatitis cD019698EFO_0004220B18.2——2—13
HepatitisD006505—K75.91—1—13
Hepatitis aD006506EFO_0007305B15——1—12
PregnancyD011247EFO_0002950Z33.1111——2
Medication adherenceD055118EFO_0006344———1—12
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
Postpartum periodD049590——11———1
Psychological well-beingD000092862———1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HepacivirusD016174——2————2
PharmacokineticsD010599——1————1
Biological availabilityD001682——1————1
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Opioid-related disordersD009293EFO_0005611F111————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Patient satisfactionD017060——————22
Hepatitis bD006509——————11
Chronic hepatitis bD019694EFO_0004239B18.1————11
DyslipidemiasD050171——————11
Sustained virologic responseD000072230——————11
Drug interactionsD004347——————11
InflammationD007249MP_0001845—————11
Disease progressionD018450——————11
Patient acceptance of health careD010342——————11
Patient preferenceD057240——————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)Loading
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
RxCUI—
ChEMBL IDCHEMBL175691
ChEBI ID68606
PubChem CID6451164
DrugBankDB08864
UNII IDFI96A8X663 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Complera – Gilead Sciences
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Edurant – Johnson & Johnson
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Odefsey – Gilead Sciences
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Tabular view
Estimated US medical usage
Rilpivirine
+
Emtricitabine
+
Tenofovir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,942 documents
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Safety
Black-box Warning
Black-box warning for: Complera, Complera access, Emtricitabine, rilpivirine, tenofovir disoproxil fumarate, Odefsey
Adverse Events
Top Adverse Reactions
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21,354 adverse events reported
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