Prescription medicine
Emtricitabine and rilpivirine and tenofovir alafenamide Brand names: Odefsey
Emtricitabine and rilpivirine and tenofovir alafenamide (Odefsey) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $130.49 per Odefsey tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the emtricitabine and rilpivirine and tenofovir alafenamide FDA label on DailyMed (effective December 2, 2025, Gilead Sciences, Inc.); the NDA 208351 record on Drugs@FDA; every emtricitabine and rilpivirine and tenofovir alafenamide label on DailyMed.
Highlights of the record
FDA label of December 2, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients with HIV-1 and HBV who discontinue ODEFSEY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Severe acute exacerbations of hepatitis B have been reported in patients with HIV-1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of ODEFSEY. Hepatic function should be monitored closely in these patients. If appropriate, anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no histor
Forms and strengths
- 200 mg / 25 mg / 25 mg
Tablet.
On the market
- Earliest approval on file
- March 1, 2016 Odefsey, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 30, 2026; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 15, 2033 Odefsey tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $130.49 per tablet Odefsey tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 3,568 through July 30, 2026
What is emtricitabine and rilpivirine and tenofovir alafenamide used for?
From the label: indications and usageODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing at least 25 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL or to replace a stable antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY [see Microbiology (12.4) and Clinical Studies (14) ]. […]
Conditions named in the indications of emtricitabine and rilpivirine and tenofovir alafenamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (ODEFSEY), Gilead Sciences, Inc., effective December 2, 2025 (SPL set ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5), via openFDA; the full label on DailyMed
Is there a generic for emtricitabine and rilpivirine and tenofovir alafenamide (Odefsey)?
The FDA approved the first generic emtricitabine and rilpivirine and tenofovir alafenamide on January 30, 2026. 1 generic application is approved; 0 of it 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 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Odefsey tablets: the compound patent runs to August 15, 2032 (pediatric exclusivity to February 15, 2033). A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2026 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for emtricitabine and rilpivirine and tenofovir alafenamide (Odefsey)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $130.49 per Odefsey tablet, up 5% from $124.34 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.
- Odefsey tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Odefsey tablet | Brand | $130.49 per tablet | $3,914.76 | +5% |
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 emtricitabine and rilpivirine and tenofovir alafenamide label say about other medicines?
The emtricitabine and rilpivirine and tenofovir alafenamide label names 44 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 |
|---|---|---|
| Acetaminophen | drug interactions | Interactions with ODEFSEY Based on drug interaction studies conducted with the fixed dose combination or components of ODEFSEY, no clinically significant drug interactions have been observed when ODEFSEY is combined with the following drugs: acetaminophen, atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol … |
| Acyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Atorvastatin | drug interactions | Interactions with ODEFSEY Based on drug interaction studies conducted with the fixed dose combination or components of ODEFSEY, no clinically significant drug interactions have been observed when ODEFSEY is combined with the following drugs: acetaminophen, atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol … |
| Azithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or Ketolide Antibiotics: clarithromycin erythromycin telithromycin; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↑ RPV ↔ clarithromycin ↔ erythromycin ↔ telithromycin; Clinical Comment: Where possible, alternatives such as azithromycin should be considered. |
| Calcium carbonate | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum, magnesium hydroxide, or calcium carbonate); Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↔ RPV (antacids taken at least 2 hours before or at least 4 hours after RPV) ↓ RPV (concomitant intake); … |
| Carbamazepine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Chlorzoxazone | drug interactions | … interactions have been observed when ODEFSEY is combined with the following drugs: acetaminophen, atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Cidofovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Cimetidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↔ RPV, (famotidine taken 12 hours before RPV or 4 hours after RPV) ↓ RPV, (famotidine taken 2 hours before RPV); … |
| Clarithromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or Ketolide Antibiotics: clarithromycin erythromycin telithromycin; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↑ RPV ↔ clarithromycin ↔ erythromycin ↔ telithromycin; Clinical Comment: Where possible, alternatives such as azithromycin should be considered. |
| Dexamethasone | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Dexlansoprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered with drugs where significant decreases in RPV plasma concentrations may occur, which may result in loss of virologic … |
| Digoxin | drug interactions | … been observed when ODEFSEY is combined with the following drugs: acetaminophen, atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Erythromycin | drug interactions | Concomitant Drug Class/Drug Name: Macrolide or Ketolide Antibiotics: clarithromycin erythromycin telithromycin; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↑ RPV ↔ clarithromycin ↔ erythromycin ↔ telithromycin; Clinical Comment: Where possible, alternatives such as azithromycin should be considered. |
Every other medicine the emtricitabine and rilpivirine and tenofovir alafenamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Esomeprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered … |
| Famotidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase=↑; Decrease=↓; … |
| Fluconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase=↑; Decrease=↓; … |
| Ganciclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Gentamicin | drug interactions | … ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Itraconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase=↑; Decrease=↓; … |
| Ketoconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase=↑; Decrease=↓; … |
| Lansoprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered … |
| Magnesium hydroxide | drug interactions | Concomitant Drug Class/Drug Name: Antacids: antacids (e.g., aluminum, magnesium hydroxide, or calcium carbonate); Effect on Concentration Increase=↑; Decrease=↓; … |
| Metformin | drug interactions | … atorvastatin, chlorzoxazone, digoxin, ethinyl estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Methadone | drug interactions | Concomitant Drug Class/Drug Name: Narcotic Analgesics: methadone; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↓ R(–) methadone ↓ S(+) methadone ↔ RPV ↔ methadone (when used with … |
| Midazolam | drug interactions | … chlorzoxazone, digoxin, ethinyl estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Nizatidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase=↑; Decrease=↓; … |
| Norethindrone | drug interactions | … chlorzoxazone, digoxin, ethinyl estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Omeprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered … |
| Oxcarbazepine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Pantoprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered … |
| Phenobarbital | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Phenytoin | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Posaconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase=↑; Decrease=↓; … |
| Rabeprazole | contraindications | St. John's wort (Hypericum perforatum) Proton Pump Inhibitors: e.g., dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole ODEFSEY is contraindicated when coadministered … |
| Ranitidine | drug interactions | Concomitant Drug Class/Drug Name: H 2 -Receptor Antagonists: cimetidine famotidine nizatidine ranitidine; Effect on Concentration Increase=↑; Decrease=↓; … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin; Effect on Concentration Increase=↑; Decrease=↓; No Effect=↔: ↓ RPV The interaction was evaluated in a clinical study. … |
| Rifampin | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Rifapentine | contraindications | Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin Antimycobacterials: rifampin, rifapentine Glucocorticoid (systemic): dexamethasone (more than a single-dose) Herbal Products: |
| Sildenafil | drug interactions | … estradiol, ledipasvir, metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Sofosbuvir | drug interactions | … metformin, midazolam, norethindrone, norgestimate, sildenafil, simeprevir, sofosbuvir, velpatasvir, and voxilaprevir. |
| Valacyclovir | drug interactions | Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g. … |
| Valganciclovir | drug interactions | … are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.5) ]. |
| Voriconazole | drug interactions | Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole posaconazole voriconazole; Effect on Concentration Increase=↑; Decrease=↓; … |
Check emtricitabine and rilpivirine and tenofovir alafenamide against other medicines
Source: FDA drug label (ODEFSEY), Gilead Sciences, Inc., effective December 2, 2025 (SPL set ea3b9ec8-e04a-412c-8b3f-e5cbc7e641d5), via openFDA; the full label on DailyMed
What do FAERS reports show for emtricitabine and rilpivirine and tenofovir alafenamide?
The FDA Adverse Event Reporting System holds 3,568 reports that list emtricitabine and rilpivirine and tenofovir alafenamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 385 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 2020 (1,378, against a median of 183 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 emtricitabine and rilpivirine and tenofovir alafenamide?
33 other medicines are given the same way (oral) and in the same FDA class as emtricitabine and rilpivirine and tenofovir alafenamide 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 |
|---|---|---|---|---|
| Lamivudine | HIV | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | HIV | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Etravirine | HIV | 5 labelers | $9.94 per tablet 200 mg tablet | A presentation being discontinued |
| Abacavir | HIV | 12 labelers | $0.546 per tablet 300 mg tablet | No current entry |
| Lamivudine and zidovudine | HIV | 7 labelers | $0.771 per tablet Lamivudine-zidovudine tablet | No current entry |
| 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 |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to emtricitabine and rilpivirine and tenofovir alafenamide
- 33 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Emtricitabine and rilpivirine and tenofovir alafenamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other