TheraRadar
Data updated: May 26, 2026

BUNAVAIL (buprenorphine hydrochloride)

Pain Approved 2014-06-06
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
11
Years on Market

Details

Status
Discontinued
First Approved
2014-06-06
Patent Cliff
2035

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Patent cliff and revenue data

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Routes
BUCCAL
Dosage Forms
FILM

Companies

BDSI
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE , NALOXONE HYDROCHLORIDE

BUNAVAIL Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
54 FDA actions from 2014 to 2022 · 1 indication expansions
Dec 2022 SUPPL
Update · REMS
FDA Letter
Jun 2022 SUPPL
Label · Labeling
FDA Letter Label
May 2022 SUPPL
Update · REMS
FDA Letter

What BUNAVAIL Treats

2 FDA approvals

Originally approved for its first indication in 2014 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

BUNAVAIL FDA Label Details

View full patent landscape →
4 OB patents · 3 families · 141 international docs across 25 countries

BUNAVAIL Patents & Exclusivity

Latest Patent: Apr 2035

Patents (4 active)

US9522188 Expires Apr 24, 2035
US8703177 Expires Aug 20, 2032
US8147866 Expires Jul 23, 2027
US9655843 Expires Jul 23, 2027
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 36 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA205637 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.