Prescription medicine
Emtricitabine and tenofovir alafenamide Brand names: Descovy
Emtricitabine and tenofovir alafenamide (Descovy) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $74.94 per Descovy 200-25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the emtricitabine and tenofovir alafenamide FDA label on DailyMed (effective July 7, 2026, Gilead Sciences, Inc.); the NDA 208215 record on Drugs@FDA; every emtricitabine and tenofovir alafenamide label on DailyMed.
Highlights of the record
FDA label of July 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B.
and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in individuals with HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals with HBV who discontinue DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2) ]. […]
Used for
From the label: indications and usageHIV-1 Treatment ( 1.1 ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg.
Forms and strengths
- 120 mg / 15 mg
- 200 mg / 25 mg
Tablet.
On the market
- Earliest approval on file
- April 4, 2016 Descovy, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first May 17, 2024; 2 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
- June 29, 2036 Descovy tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $74.94 per tablet Descovy 200-25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 11,272 through July 30, 2026
What is emtricitabine and tenofovir alafenamide used for?
From the label: indications and usageHIV-1 Treatment ( 1.1 ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescent patients weighing at least 35 kg. for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor. […]
Conditions named in the indications of emtricitabine and tenofovir alafenamide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor.
Source: FDA drug label (DESCOVY), Gilead Sciences, Inc., effective July 7, 2026 (SPL set 06f66e98-e6ee-4538-9506-6c1282cc14c1), via openFDA; the full label on DailyMed
What does the patient leaflet for emtricitabine and tenofovir alafenamide say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DESCOVY?DESCOVY can cause serious side effects, including: Worsening of hepatitis B virus (HBV). Your healthcare provider will test you for HBV before or when you start treatment with DESCOVY. If you have HBV and take DESCOVY, your HBV may get worse (flare-up) if you stop taking DESCOVY. A “flare-up” is when your HBV suddenly returns in a worse way than before. Do not run out of DESCOVY. Refill your prescription or talk to your healthcare provider before your DESCOVY is all gone. Do not stop taking DESCOVY without first talking to your healthcare provider. If you stop taking DESCOVY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DESCOVY. For more information about side effects, see the section “ What are the possible side effects of DESCOVY? ” Other important information for people who take DESCOVY to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1), also called pre-exposure prophylaxis or “PrEP”: Before taking DESCOVY to reduce your risk of getting HIV-1: You must be HIV-1 negative to start DESCOVY. You must get tested to make sure that you do not already have HIV-1. Do not take DESCOVY for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. Some HIV-1 tests can miss HIV-1 in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting DESCOVY or at any time while taking DESCOVY. […]
From the patient leaflet: How should I store DESCOVY?Store DESCOVY at room temperature between 68°F to 77°F (20°C to 25°C). Keep DESCOVY in its original bottle or blister pack. Keep the bottle tightly closed. The bottle containing 200 mg/25 mg tablets may have a tamper-evident seal over the cap. If a tamper-evident seal is present, do not use if the seal is opened or damaged. Keep DESCOVY and all medicines out of reach of children.
Source: FDA drug label (DESCOVY), Gilead Sciences, Inc., effective July 7, 2026 (SPL set 06f66e98-e6ee-4538-9506-6c1282cc14c1), via openFDA; the full label on DailyMed
Is there a generic for emtricitabine and tenofovir alafenamide (Descovy)?
The FDA approved the first generic emtricitabine and tenofovir alafenamide on May 17, 2024. 4 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.
The Orange Book lists 6 patents for Descovy tablets: the compound patent runs to August 15, 2032 (pediatric exclusivity to February 15, 2033), and the last listed entry to June 29, 2036. 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
- 2024 first generic approved
- 2036 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 tenofovir alafenamide (Descovy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $74.94 per Descovy 200-25 mg tablet, up 5% from $71.32 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.
- Descovy 200-25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Descovy 120-15 mg tablet | Brand | $74.85 per tablet | $2,245.62 | +5% |
| Descovy 200-25 mg tablet | Brand | $74.94 per tablet | $2,248.24 | +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 tenofovir alafenamide label say about other medicines?
The emtricitabine and tenofovir alafenamide label names 34 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 |
|---|---|---|
| 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 (5.4) ]. |
| Atazanavir | drug interactions | Concomitant Drug Class/Drug Name: atazanavir/cobicistat; Effect on Concentration ↓=Decrease: ↑ TAF; Clinical Comment: Coadministration with DESCOVY in pediatric patients weighing 14 to < 35 kg is not recommended [see ]. |
| Atazanavir and cobicistat | drug interactions | Drug Interactions Concomitant Drug Class: Drug Name Effect on Concentration ↓=Decrease Clinical Comment ↑= Increase Antiretroviral Agents: Protease Inhibitors (PI) tipranavir/ritonavir ↓ TAF Coadministration with DESCOVY is not recommended. … |
| Buprenorphine | drug interactions | … interactions have been either observed or are expected when DESCOVY is combined with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↓=Decrease: ↓ TAF; Clinical Comment: Consider alternative anticonvulsant. |
| 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 (5.4) ]. |
| Cobicistat | drug interactions | Concomitant Drug Class/Drug Name: atazanavir/cobicistat; Effect on Concentration ↓=Decrease: ↑ TAF; Clinical Comment: Coadministration with DESCOVY in pediatric patients weighing 14 to < 35 kg is not recommended [see ]. |
| Darunavir | drug interactions | … following antiretroviral agents: atazanavir with ritonavir, atazanavir with cobicistat (in those weighing ≥35 kg), darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. … |
| Dolutegravir | drug interactions | … ritonavir, atazanavir with cobicistat (in those weighing ≥35 kg), darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. … |
| Efavirenz | drug interactions | … atazanavir with cobicistat (in those weighing ≥35 kg), darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. … |
| 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), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ]. |
| Gentamicin | 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 (5.4) ]. |
| Itraconazole | drug interactions | … have been either observed or are expected when DESCOVY is combined with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Ketoconazole | drug interactions | … either observed or are expected when DESCOVY is combined with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
Every other medicine the emtricitabine and tenofovir alafenamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lopinavir and ritonavir | drug interactions | Drug Interactions Concomitant Drug Class: Drug Name Effect on Concentration ↓=Decrease Clinical Comment ↑= Increase Antiretroviral Agents: Protease Inhibitors (PI) tipranavir/ritonavir ↓ TAF … |
| Lorazepam | drug interactions | … with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Maraviroc | drug interactions | … cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. … |
| Methadone | drug interactions | … following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Midazolam | drug interactions | … drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Naloxone | drug interactions | … buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Nevirapine | drug interactions | … dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. … |
| Oxcarbazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Phenobarbital | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Phenytoin | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Raltegravir | drug interactions | … efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. No clinically significant drug interactions have been either observed or are expected when … |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Rifampin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials: rifabutin rifampin rifapentine; Effect on Concentration ↓=Decrease: ↓ TAF; … |
| Rilpivirine | drug interactions | … ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. No clinically significant drug interactions have been either observed or are expected when DESCOVY is … |
| Ritonavir | drug interactions | Concomitant Drug Class/Drug Name: tipranavir/ritonavir; Effect on Concentration ↓=Decrease: ↓ TAF; Clinical Comment: Coadministration with DESCOVY is not recommended. |
| Sertraline | drug interactions | … midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline. |
| Sofosbuvir | drug interactions | … lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir. No clinically significant drug interactions have been either observed or are expected when DESCOVY is combined … |
| 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 (5.4) ]. |
Check emtricitabine and tenofovir alafenamide against other medicines
Source: FDA drug label (DESCOVY), Gilead Sciences, Inc., effective July 7, 2026 (SPL set 06f66e98-e6ee-4538-9506-6c1282cc14c1), via openFDA; the full label on DailyMed
What do FAERS reports show for emtricitabine and tenofovir alafenamide?
The FDA Adverse Event Reporting System holds 11,272 reports that list emtricitabine and tenofovir alafenamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 364 are coded as a death and 1,206 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 (4,101, against a median of 743 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 tenofovir alafenamide?
35 other medicines are given the same way (oral) and in the same FDA class as emtricitabine 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 |
| 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 |
| Zidovudine | HIV | 3 labelers | $0.464 per tablet 300 mg tablet | No current entry |
| Abacavir and lamivudine | HIV | 6 labelers | $1.48 per unit 600-300 mg | No current entry |
| Efavirenz and lamivudine and tenofovir disoproxil | HIV | 1 labeler | n/a | No current entry |
| Abacavir and dolutegravir and lamivudine | HIV | none listed | $130.01 per tablet 600-50-300 mg tablet | No current entry |
Every medicine labeled for the same conditions as emtricitabine and tenofovir alafenamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to emtricitabine and tenofovir alafenamide
- 35 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Emtricitabine and tenofovir alafenamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other