Vemlidy
An oral daily tablet used to treat chronic hepatitis B infection in adults.
Where Tenofovir Alafenamide is approved
All regulators →Of the three regulators tracked here, the first to approve Tenofovir Alafenamide was the US, on 10 Nov 2016. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tenofovir Alafenamide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tenofovir Alafenamide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 15 Feb 2033 (US 8754065, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 15 Feb 2033 (US 8754065, with paediatric extension).
- Exclusivity NPP: New patient population, until 27 Mar 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Tenofovir Alafenamide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tenofovir Alafenamide works
All drug targets →- Human immunodeficiency virus type 1 reverse transcriptase inhibitor InhibitorChEMBL only
- OverweightPhase 3
- Hepatitis C virus infectionPhase 3
- Obesity disorderPhase 3
- B-cell chronic lymphocytic leukemiaPhase 2
- Chronic hepatitis B virus infectionPhase 2
- Chronic kidney diseasePhase 2
- Diffuse large B-cell lymphomaPhase 2
- Hepatitis D virus infectionPhase 2
- TuberculosisPhase 2
- Alzheimer diseasePhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2107825, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 14054, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tenofovir Alafenamide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Tenofovir Alafenamide. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tenofovir alafenamide for treating chronic hepatitis B (terminated appraisal) NICE TA435 | Terminated (no company submission) | 22 Mar 2017 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tenofovir Alafenamide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: VemlidyEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Tenofovir Alafenamide
- ATC code
- J05AF13
- ChEMBL
- CHEMBL2107825
- DrugBank
- DB09299
- PubChem CID
- 9574768
- CAS number
- 379270-37-8
- FDA UNII
- EL9943AG5J
- Wikidata
- Q22075912
- Wikipedia
- Tenofovir alafenamide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Vemlidy is used for
VEMLIDY 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. ( 1 )
How it works
12.1 Mechanism of Action Tenofovir alafenamide is an antiviral drug against the hepatitis B virus [see Microbiology (12.4) ] .
Related clinical trials recruiting now
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 5 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.