Prescription medicine
Tenofovir alafenamide Brand names: Vemlidy
Tenofovir alafenamide (Vemlidy) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $51.98 per Vemlidy 25 mg tablet in the October 7, 2026 NADAC survey.
- No generic listed
- Boxed warning
Check it at the source: the tenofovir alafenamide FDA label on DailyMed (effective July 14, 2025, Gilead Sciences, Inc.); the NDA 208464 record on Drugs@FDA; every tenofovir alafenamide label on DailyMed.
Highlights of the record
FDA label of July 14, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B.
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ]. WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Discontinuation of anti-hepatitis B therapy may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely in patients who discontinue VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Used for
From the label: indications and usageVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ].
Forms and strengths
- 25 mg
Tablet.
On the market
- Earliest approval on file
- November 10, 2016 Vemlidy, Gilead Sciences Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first March 30, 2023; 1 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 Vemlidy tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $51.98 per tablet Vemlidy 25 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,061 through July 30, 2026
What is tenofovir alafenamide used for?
From the label: indications and usageVEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ]. VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.
Conditions named in the indications of 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 (VEMLIDY), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 72e6b33c-0351-4070-9172-eeaa186c01d2), via openFDA; the full label on DailyMed
What does the patient leaflet for 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 VEMLIDY?VEMLIDY can cause serious side effects, including: Worsening of hepatitis B virus (HBV) infection. Your HBV infection may get worse (flare-up) if you take VEMLIDY and then stop taking it. A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not run out of VEMLIDY. Refill your prescription or talk to your healthcare provider before your VEMLIDY is all gone. Do not stop taking VEMLIDY without first talking to your healthcare provider. If you stop taking VEMLIDY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VEMLIDY. For more information about side effects, see the section " What are the possible side effects of VEMLIDY? " What is VEMLIDY? VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults and children 6 years of age and older who weigh at least 55 pounds (25 kg) with stable (compensated) liver disease. VEMLIDY may lower the amount of HBV in your body. VEMLIDY may improve the condition of your liver. It is not known if VEMLIDY is safe and effective in children with chronic HBV infection who are under 6 years of age or weigh less than 55 pounds (25 kg).
From the patient leaflet: How should I store VEMLIDY?Store VEMLIDY below 86 °F (30 °C). Keep VEMLIDY in its original container. Keep the container tightly closed. VEMLIDY comes in a child-resistant package. Keep VEMLIDY and all medicines out of reach of children.
Source: FDA drug label (VEMLIDY), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 72e6b33c-0351-4070-9172-eeaa186c01d2), via openFDA; the full label on DailyMed
Is there a generic for tenofovir alafenamide (Vemlidy)?
The FDA approved the first generic tenofovir alafenamide on March 30, 2023. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Vemlidy 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
- 2023 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 tenofovir alafenamide (Vemlidy)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $51.98 per Vemlidy 25 mg tablet, up 6% from $49.01 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.
- Vemlidy 25 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Vemlidy 25 mg tablet | Brand | $51.98 per tablet | $1,559.52 | +6% |
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 tenofovir alafenamide label say about other medicines?
The tenofovir alafenamide label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name tenofovir alafenamide. 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 (5.3) ]. |
| Carbamazepine | drug interactions | Concomitant Drug Class/Drug Name: Anticonvulsants:; Effect on Concentration ↓ = decrease.: ↓ tenofovir alafenamide; Clinical Comment: When coadministered with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. … |
| 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 (5.3) ]. |
| Emtricitabine | drug interactions | Information regarding potential drug-drug interactions with HIV antiretrovirals is not provided (see the prescribing information for emtricitabine/tenofovir alafenamide for interactions with HIV antiretrovirals). |
| 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 (5.3) ]. |
| 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 (5.3) ]. |
| Ledipasvir and sofosbuvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Midazolam | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Oxcarbazepine | drug interactions | … tenofovir alafenamide dose should be increased to two tablets once daily. Coadministration of VEMLIDY with oxcarbazepine, phenobarbital, or phenytoin is not recommended. |
| Phenobarbital | drug interactions | … alafenamide dose should be increased to two tablets once daily. Coadministration of VEMLIDY with oxcarbazepine, phenobarbital, or phenytoin is not recommended. |
| Phenytoin | drug interactions | … be increased to two tablets once daily. Coadministration of VEMLIDY with oxcarbazepine, phenobarbital, or phenytoin is not recommended. |
| Rifabutin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials:; Effect on Concentration ↓ = decrease.: ↓ tenofovir alafenamide; Clinical Comment: Coadministration of VEMLIDY with rifabutin, rifampin or rifapentine is not recommended. |
| Rifampin | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials:; Effect on Concentration ↓ = decrease.: ↓ tenofovir alafenamide; Clinical Comment: Coadministration of VEMLIDY with rifabutin, rifampin or rifapentine is not recommended. |
| Rifapentine | drug interactions | Concomitant Drug Class/Drug Name: Antimycobacterials:; Effect on Concentration ↓ = decrease.: ↓ tenofovir alafenamide; Clinical Comment: Coadministration of VEMLIDY with rifabutin, rifampin or rifapentine is not recommended. |
Every other medicine the tenofovir alafenamide label names
| Medicine named | Section | What the label says |
|---|---|---|
| Sertraline | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Sofosbuvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Sofosbuvir and velpatasvir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Sofosbuvir and velpatasvir and voxilaprevir | drug interactions | Named in a table that the FDA label file prints without its column breaks; the full label shows the table. |
| Tenofovir disoproxil | warnings and precautions | … cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, alone or in combination with other antiretrovirals. |
| 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 (5.3) ]. |
Other labels that name tenofovir alafenamide
Source: FDA drug label (VEMLIDY), Gilead Sciences, Inc., effective July 14, 2025 (SPL set 72e6b33c-0351-4070-9172-eeaa186c01d2), via openFDA; the full label on DailyMed
What do FAERS reports show for tenofovir alafenamide?
The FDA Adverse Event Reporting System holds 4,061 reports that list tenofovir alafenamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 431 are coded as a death and 1,162 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 tenofovir alafenamide?
4 other medicines are given the same way (oral) and in the same FDA class as tenofovir alafenamide or labeled mainly for the same use (hepatitis b), the same class first. Hepatitis B lists all 7 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Entecavir | Hepatitis B | 16 labelers | $0.219 per tablet 0.5 mg tablet | No current entry |
| Lamivudine | Hepatitis B | 14 labelers | $0.489 per tablet 150 mg tablet | No current entry |
| Tenofovir disoproxil | Hepatitis B | 15 labelers | $0.294 per tablet 300 mg tablet | No current entry |
| Adefovir dipivoxil | Hepatitis B | 2 labelers | $21.73 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as tenofovir alafenamide
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to tenofovir alafenamide
- 4 medicines for the same use
- Other hepatitis b virus nucleoside analog reverse transcriptase inhibitors
- the pharmacologic class, with prices and generics
- Tenofovir alafenamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other