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Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Entecavir
Brand: BARACLUDE
First FDA approval:
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Lamivudine
Brand: EPIVIR
First FDA approval:
Lowest NADACAcquisition cost floor across all NDCs
$0.222Per unit
$0.249Per unit
Average NADACAcross all dosage forms and strengths
$2.36Up to $44.19
$1.19Up to $8.87
Generic manufacturersActive ANDA holders — FDA Orange Book
816 total ANDAs filed
1020 total ANDAs filed
Annualized Part D spendCY2024 — CMS Part D Spending Dashboard
$44.1MFull year
$8.4MFull year
Part D claims (CY24)Total fills, all strengths
210K51K beneficiaries
55K11K beneficiaries
Avg cost per claimCalculated: total spend ÷ total claims
$210Per claim, all NDCs
$152Per claim, all NDCs
Part D plans surveyed2026 plan year — CMS Formulary file
329Across CMS plan year
329Across CMS plan year
Prior-authorization frictionPlan-NDC pairs requiring PA
8Minimal friction
1Minimal friction
Step therapy appliedPlan-NDC pairs requiring step therapy
52Limited friction
0None
FDA shortage statusLive cross-reference vs FDA Drug Shortage Database
NoneClear
NoneClear
Generic availableFDA Orange Book
Yes8 manufacturers
Yes10 manufacturers