VEMLIDY (tenofovir alafenamide fumarate)
VEMLIDY is indicated for the treatment of Hepatitis B.
How VEMLIDY Works
Tenofovir alafenamide, the active ingredient in Vemlidy, is a nucleoside analog reverse transcriptase inhibitor that targets the hepatitis B virus. The drug functions by inhibiting the viral reverse transcriptase enzyme, which is essential for the virus to replicate its genetic material. By blocking this biological process, the medication prevents the virus from multiplying within the body.
Details
- Status
- Prescription
- First Approved
- 2016-11-10
- Patent Cliff
- 2033
- Revenue
- $300M (Q4-2025)
- Routes
- ORAL
- Dosage Forms
- TABLET
VEMLIDY Approval History
What VEMLIDY Treats
1 indicationsVEMLIDY is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatitis B
VEMLIDY Boxed Warning
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...
WARNING: 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. ( 5.1 )
VEMLIDY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VEMLIDY
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04496882 CHANGE | 201911095MIPD | Ph 4 | active not recruiting | Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue |
| NCT06221657 | IIT-TAF-01 | Ph 4 | not yet recruiting | Clinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VEMLIDY FDA Label Details
Indications & Usage
FDA Label (PDF)VEMLIDY is indicated for the treatment of Hepatitis B.
WARNING: 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 month...
VEMLIDY Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for VEMLIDY
Revenue Insights
- • Q4-2025: $300M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.