Prescription medicine
Rilpivirine Brand names: Edurant
Rilpivirine (Edurant) is a prescription medicine with an FDA approval on record since 2011. A generic is approved and listed by 2 labelers, but in the October 7, 2026 NADAC survey pharmacies bought only the brand, at $48.04 per Edurant 25 mg tablet.
- Generic approved
Check it at the source: the rilpivirine FDA label on DailyMed (effective August 28, 2025, Janssen Products, LP); the NDA 202022 record on Drugs@FDA; every rilpivirine label on DailyMed.
Highlights of the record
FDA label of August 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageEDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.
Forms and strengths
- 2.5 mg
- 25 mg
Film-coated tablet; tablet for suspension.
On the market
- Earliest approval on file
- May 20, 2011 Edurant, Janssen Prods; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first January 29, 2026; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 2 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 23, 2037 Edurant Ped tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $48.04 per tablet Edurant 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,599 through July 30, 2026
What is rilpivirine used for?
From the label: indications and usageEDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.1 ). Limitations of Use: More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. […]
Conditions named in the indications of rilpivirine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (EDURANT), Janssen Products, LP, effective August 28, 2025 (SPL set 03880372-2c68-45c6-a53a-f420c49541d6), via openFDA; the full label on DailyMed
Is there a generic for rilpivirine (Edurant)?
The FDA approved the first generic rilpivirine on January 29, 2026. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists rilpivirine from 2 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it. In the latest NADAC survey pharmacies bought only the brand, so a generic may not be on sale yet.
The Orange Book lists 1 patent for Edurant Ped tablets, the last expiring on October 23, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2026 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for rilpivirine (Edurant)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $48.04 per Edurant 25 mg tablet, about the same as a year earlier. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Edurant 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Edurant 25 mg tablet | Brand | $48.04 per tablet | $1,441.23 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the rilpivirine label say about other medicines?
The rilpivirine label names 53 other medicines in its interaction, contraindication or warning sections. The labels of 29 other medicines name rilpivirine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abacavir | drug interactions | No clinically relevant drug-drug interaction is expected when EDURANT or EDURANT PED is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. |
| Acetaminophen | drug interactions | In addition to the drugs included in Table 6, the interaction between EDURANT and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3) ]: acetaminophen, atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone … |
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir); Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ boosted PI; … |
| Atorvastatin | drug interactions | In addition to the drugs included in Table 6, the interaction between EDURANT and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3) ]: acetaminophen, atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone … |
| Azithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: azithromycin clarithromycin erythromycin; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ azithromycin ↔ clarithromycin ↔ erythromycin; … |
| Cabotegravir | drug interactions | In addition to the drugs included in Table 6, the interaction between EDURANT and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3) ]: acetaminophen, atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone … |
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (antacids taken at least 2 hours before or at least 4 hours after rilpivirine); … |
| Carbamazepine | contraindications | Drug Class: Anticonvulsants; Contraindicated Drugs in Class: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response. |
| Chlorzoxazone | drug interactions | In addition to the drugs included in Table 6, the interaction between EDURANT and the following drugs was evaluated in clinical studies and no dose adjustment is needed for either drug [see Clinical Pharmacology (12.3) ]: acetaminophen, atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone … |
| Cimetidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (famotidine taken 12 hours before rilpivirine or 4 hours after rilpivirine); … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: azithromycin clarithromycin erythromycin; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ azithromycin ↔ clarithromycin ↔ erythromycin; … |
| Darunavir | drug interactions | Concomitant Drug Class/Drug Name: darunavir/ritonavir; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ boosted darunavir; Clinical Comment: Concomitant use of EDURANT or EDURANT PED with darunavir/ritonavir may cause an increase in the plasma concentrations of rilpivirine (inhibition of … |
| Dexamethasone | contraindications | Drug Class: Glucocorticoid (systemic); Contraindicated Drugs in Class: Dexamethasone (more than a single-dose treatment); Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response. |
| Digoxin | drug interactions | Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
Every other medicine the rilpivirine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Efavirenz | drug interactions | Concomitant Drug Class/Drug Name: Other NNRTIs (efavirenz, etravirine, nevirapine); Effect on Concentration of Rilpivirine or Concomitant Drug: ↓ rilpivirine ↔ other NNRTIs |
| Emtricitabine | drug interactions | … is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: azithromycin clarithromycin erythromycin; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ azithromycin … |
| Esomeprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Etravirine | drug interactions | Concomitant Drug Class/Drug Name: Other NNRTIs (efavirenz, etravirine, nevirapine); Effect on Concentration of Rilpivirine or Concomitant Drug: ↓ rilpivirine ↔ other NNRTIs |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (famotidine taken … |
| Fluconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole This interaction study has been performed with a dose higher than the recommended dose for EDURANT … |
| Fosamprenavir | drug interactions | Concomitant Drug Class/Drug Name: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir); … |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole This interaction study has been performed with a dose higher than the recommended dose for EDURANT … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole This interaction study has been performed with a dose higher than the recommended dose for EDURANT … |
| Lamivudine | drug interactions | … coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. |
| Lansoprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Lopinavir and ritonavir | drug interactions | Lopinavir/ritonavir ↑ rilpivirine ↔ boosted lopinavir Concomitant use of EDURANT or EDURANT PED with lopinavir/ritonavir may cause an increase in the plasma concentrations of rilpivirine (inhibition … |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (antacids … |
| Maraviroc | drug interactions | No clinically relevant drug-drug interaction is expected when EDURANT or EDURANT PED is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and … |
| Metformin | drug interactions | Rilpivirine did not have a clinically significant effect on the pharmacokinetics of digoxin or metformin. |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic Analgesics: methadone; Effect on Concentration of Rilpivirine or Concomitant Drug: ↓ R(-) methadone ↓ S(+) methadone; … |
| Nelfinavir | drug interactions | Concomitant Drug Class/Drug Name: Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir); Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ unboosted PI; … |
| Nevirapine | drug interactions | Concomitant Drug Class/Drug Name: Other NNRTIs (efavirenz, etravirine, nevirapine); Effect on Concentration of Rilpivirine or Concomitant Drug: ↓ rilpivirine ↔ other NNRTIs |
| Nizatidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (famotidine taken … |
| Norethindrone | drug interactions | … acetaminophen, atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone, raltegravir, sildenafil, simeprevir and tenofovir disoproxil fumarate. |
| Omeprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Oxcarbazepine | contraindications | Drug Class: Anticonvulsants; Contraindicated Drugs in Class: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin; Clinical Comment: Potential for significant decreases in rilpivirine plasma … |
| Pantoprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Phenobarbital | contraindications | Drug Class: Anticonvulsants; Contraindicated Drugs in Class: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin; Clinical Comment: Potential for significant decreases in rilpivirine plasma … |
| Phenytoin | contraindications | Drug Class: Anticonvulsants; Contraindicated Drugs in Class: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin; Clinical Comment: Potential for significant decreases in rilpivirine plasma … |
| Posaconazole | drug interactions | … recommendation is applicable to the recommended doses of EDURANT once daily. posaconazole voriconazole; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↓ ketoconazole; … |
| Rabeprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Raltegravir | drug interactions | … atorvastatin, chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone, raltegravir, sildenafil, simeprevir and tenofovir disoproxil fumarate. |
| Ranitidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration of Rilpivirine or Concomitant Drug: ↔ rilpivirine (famotidine taken … |
| Ribavirin | drug interactions | No clinically relevant drug-drug interaction is expected when EDURANT or EDURANT PED is coadministered with maraviroc, ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin The interaction between EDURANT and the drug was evaluated in a clinical study. All other drug-drug interactions shown are predicted.; … |
| Rifampin | contraindications | Drug Class: Antimycobacterials; Contraindicated Drugs in Class: Rifampin Rifapentine; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme … |
| Rifapentine | contraindications | Drug Class: Antimycobacterials; Contraindicated Drugs in Class: Rifampin Rifapentine; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme … |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: darunavir/ritonavir; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↔ boosted darunavir; … |
| Sildenafil | drug interactions | … chlorzoxazone, cabotegravir, ethinylestradiol, norethindrone, raltegravir, sildenafil, simeprevir and tenofovir disoproxil fumarate. |
| Tenofovir disoproxil | drug interactions | … ethinylestradiol, norethindrone, raltegravir, sildenafil, simeprevir and tenofovir disoproxil fumarate. |
| Voriconazole | drug interactions | … applicable to the recommended doses of EDURANT once daily. posaconazole voriconazole; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↓ ketoconazole; … |
| Zidovudine | drug interactions | … ribavirin or the NRTIs abacavir, emtricitabine, lamivudine, stavudine and zidovudine. |
Other labels that name rilpivirine
Source: FDA drug label (EDURANT), Janssen Products, LP, effective August 28, 2025 (SPL set 03880372-2c68-45c6-a53a-f420c49541d6), via openFDA; the full label on DailyMed
What do FAERS reports show for rilpivirine?
The FDA Adverse Event Reporting System holds 8,599 reports that list rilpivirine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 289 are coded as a death and 919 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (1,785, against a median of 288 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as rilpivirine?
41 other medicines are given the same way (oral) and in the same FDA class as rilpivirine or labeled mainly for the same use (HIV), the same class first. HIV lists all 47 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Nevirapine | HIV | 6 labelers | $0.147 per tablet 200 mg tablet | No current entry |
| Efavirenz | HIV | 5 labelers | $1.28 per tablet 600 mg tablet | No current entry |
| Efavirenz and emtricitabine and tenofovir disoproxil | HIV | 7 labelers | $1.12 per tablet 600-200-300 mg tablet | No current entry |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | No current entry |
| Doravirine | HIV | none listed | $60.79 per tablet 100 mg tablet | No current entry |
| Doravirine and islatravir | HIV | none listed | n/a | No current entry |
| Doravirine and lamivudine and tenofovir disoproxil | HIV | none listed | $93.06 per tablet 100-300-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as rilpivirine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to rilpivirine
- 41 medicines for the same use
- Other human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Rilpivirine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other