Prescription medicine
Dolutegravir and rilpivirine Brand names: Juluca
Dolutegravir and rilpivirine (Juluca) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $121.87 per Juluca 50-25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the dolutegravir and rilpivirine FDA label on DailyMed (effective October 29, 2025, ViiV Healthcare Company); the NDA 210192 record on Drugs@FDA; every dolutegravir and rilpivirine label on DailyMed.
Highlights of the record
FDA label of October 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageJULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual comp
Forms and strengths
- 50 mg / 25 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 21, 2017 Juluca, Viiv Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 5, 2038 Juluca tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $121.87 per tablet Juluca 50-25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,742 through July 30, 2026
What is dolutegravir and rilpivirine used for?
From the label: indications and usageJULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA. […]
Conditions named in the indications of dolutegravir and rilpivirine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor.
Source: FDA drug label (Juluca), ViiV Healthcare Company, effective October 29, 2025 (SPL set 806653d1-bf35-4924-b999-ad5d21821cc1), via openFDA; the full label on DailyMed
Is there a generic for dolutegravir and rilpivirine (Juluca)?
No generic dolutegravir and rilpivirine is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 4 patents for Juluca tablets: the compound patent runs to January 24, 2031, and the last listed entry to September 5, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dolutegravir and rilpivirine (Juluca)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $121.87 per Juluca 50-25 mg tablet, up 3% from $118.18 on October 8, 2025. 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.
- Juluca 50-25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Juluca 50-25 mg tablet | Brand | $121.87 per tablet | $3,655.99 | +3% |
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 dolutegravir and rilpivirine label say about other medicines?
The dolutegravir and rilpivirine label names 27 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Azithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Clarithromycin Erythromycin Telithromycin; Effect on Concentration: ↔Dolutegravir ↑Rilpivirine; Clinical Comment: Where possible, consider alternatives, such as azithromycin. |
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration: ↓Rilpivirine; Clinical Comment: Administer JULUCA 4 hours before or 6 hours after taking antacids. |
| 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 cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response. |
| Cimetidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -receptor antagonists: Famotidine Cimetidine Nizatidine Ranitidine; Effect on Concentration: ↔Dolutegravir ↓Rilpivirine; Clinical Comment: JULUCA should only be administered at least 4 hours before or 12 hours after taking H 2 -receptor antagonists. |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Clarithromycin Erythromycin Telithromycin; Effect on Concentration: ↔Dolutegravir ↑Rilpivirine; Clinical Comment: Where possible, consider alternatives, such as azithromycin. |
| Dalfampridine | drug interactions | Concomitant Drug Class/Drug Name: Potassium channel blocker: Dalfampridine; Effect on Concentration: ↑Dalfampridine; Clinical Comment: Elevated levels of dalfampridine increase the risk of seizures. … |
| 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 cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response. |
| Dofetilide | contraindications | • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )]. |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or ketolide antibiotics: Clarithromycin Erythromycin Telithromycin; Effect on Concentration: ↔Dolutegravir ↑Rilpivirine; Clinical Comment: Where possible, consider alternatives, such as azithromycin. |
| Esomeprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response. |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -receptor antagonists: Famotidine Cimetidine Nizatidine Ranitidine; Effect on Concentration: ↔Dolutegravir ↓Rilpivirine; Clinical Comment: JULUCA should only be administered at least 4 hours before or 12 hours after taking H 2 -receptor antagonists. |
| Lansoprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response. |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate); Effect on Concentration: ↓Rilpivirine; Clinical Comment: Administer JULUCA 4 hours before or 6 hours after taking antacids. |
| Metformin | drug interactions | Concomitant Drug Class/Drug Name: Antidiabetic: Metformin b; Effect on Concentration: ↑Metformin; Clinical Comment: Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of JULUCA and metformin. |
Every other medicine the dolutegravir and rilpivirine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic analgesic: Methadone b; Effect on Concentration: ↔Dolutegravir ↓Methadone ↔Rilpivirine; … |
| Nizatidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -receptor antagonists: Famotidine Cimetidine Nizatidine Ranitidine; Effect on Concentration: ↔Dolutegravir ↓Rilpivirine; … |
| 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 … |
| Rabeprazole | contraindications | Drug Class: Proton Pump Inhibitors; Contraindicated Drugs in Class: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole; … |
| Ranitidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -receptor antagonists: Famotidine Cimetidine Nizatidine Ranitidine; Effect on Concentration: ↔Dolutegravir ↓Rilpivirine; … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterial: Rifabutin b; Effect on Concentration: ↔Dolutegravir ↔Rifabutin ↓Rilpivirine; … |
| Rifampin | contraindications | Drug Class: Antimycobacterials; Contraindicated Drugs in Class: Rifampin Rifapentine; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to cytochrome P450 … |
| Rifapentine | contraindications | Drug Class: Antimycobacterials; Contraindicated Drugs in Class: Rifampin Rifapentine; Clinical Comment: Potential for significant decreases in rilpivirine plasma concentrations due to cytochrome P450 … |
| Sucralfate | drug interactions | Concomitant Drug Class/Drug Name: Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing products b or laxatives Sucralfate Buffered medications; … |
Source: FDA drug label (Juluca), ViiV Healthcare Company, effective October 29, 2025 (SPL set 806653d1-bf35-4924-b999-ad5d21821cc1), via openFDA; the full label on DailyMed
What do FAERS reports show for dolutegravir and rilpivirine?
The FDA Adverse Event Reporting System holds 1,742 reports that list dolutegravir and rilpivirine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 309 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 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 dolutegravir and rilpivirine?
38 other medicines are given the same way (oral) and in the same FDA class as dolutegravir and 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 |
| Raltegravir | HIV | 1 labeler | $34.54 per tablet 400 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 |
| Cabotegravir | HIV | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as dolutegravir and rilpivirine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dolutegravir and rilpivirine
- 38 medicines for the same use
- Other human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Dolutegravir and rilpivirine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other