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11 dimensions
Partial Opioid Agonist
Buprenorphine and Naloxone
Brand: Buprenorphine HCl and Naloxone HCl
First FDA approval:
Lowest NADACAcquisition cost floor across all NDCs
$0.481Per unit
$0.294Per unit
Average NADACAcross all dosage forms and strengths
$3.09Up to $21.14
$25.64Up to $131.09
Generic manufacturersActive ANDA holders — FDA Orange Book
00 total ANDAs filed
1539 total ANDAs filed
Annualized Part D spendCY2024 — CMS Part D Spending Dashboard
—Full year
$536.9MFull year
Part D claims (CY24)Total fills, all strengths
—— beneficiaries
1.7M350K beneficiaries
Avg cost per claimCalculated: total spend ÷ total claims
—Per claim, all NDCs
$317Per 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
0Zero PA friction
631Substantial friction
Step therapy appliedPlan-NDC pairs requiring step therapy
0None
0None
FDA shortage statusLive cross-reference vs FDA Drug Shortage Database
NoneClear
NoneClear
Generic availableFDA Orange Book
NoBrand-only
Yes15 manufacturers