DrugDashboards

Belbuca

buprenorphine hydrochloride · BUPRENORPHINE HYDROCHLORIDE 750 ug/1 · Film, Soluble · Buccal · BioDelivery Sciences International Inc

NDC 59385-0026-60 · 60 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has held steady around $18.10 per unit over the past year. Put together: worth watching — several of the pressures that precede supply trouble are present at once.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

One drug, every price

The same NDC has different prices depending on who is paying. Units differ between rungs — compare within a rung over time, not rung against rung, unless the units match.

ⓘ How this was built
Data sources
  • CMS NADAC (pharmacy acquisition, weekly)
  • CMS Part B ASP quarterly payment limits
  • CMS Maximum Fair Prices (IRA negotiated, NDC-level)
  • Medicare Part D Spending by Drug (data.cms.gov, name-matched)
  • VA FSS / Big4 federal contract prices (va.gov, twice monthly)
  • ACA Federal Upper Limits + weighted AMP (data.medicaid.gov, monthly)
  • California SB-17 WAC filings (list price, per package)
Method

Each rung is the newest figure for this NDC from one federal price system, shown with its own unit. Part D is matched by drug name because CMS publishes no NDCs there; it is gross spending, before confidential rebates.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

  • Pharmacies pay (NADAC)$18.10per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$12.76per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$18.50per unitnegotiated price across 367 plans — before rebates · Apr 1, 2026
  • List price (WAC, as filed)$1,135.33per packageCollegium Pharmaceuticals · Jan 1, 2026

Medicare Part D

All Part D pricing →
ⓘ How this was built
Data sources
  • CMS quarterly Prescription Drug Plan Formulary & Pricing files (SPUF)
Method

Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.

Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.

Plans pay at point of sale
$18.50per unit
middle half $17.90$19.11 · 367 plans · Apr 1, 2026
Est. net of rebates
$11.10–$13.87
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
7%of plans cover it
tier 3 · prior auth 54% · step therapy 0% · qty limit 67%

*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.

NADAC price per unit

$0$10.00$20.00Feb 2019Sep 2026$18.10
35 price points · per EASource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$1,135.33
Reported to Texas DSHS · 2026 annual filing · Collegium Pharmaceutical Inc

Manufacturer list price as filed — not what pharmacies actually pay after discounts.

Medicaid spend (2025)

$4.8M
4,969 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

30Elevated risk

The score is counting real pressure here. One of these alone is routine; it’s the combination that makes this market worth watching.

  • 1 active manufacturer+30

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for buprenorphine hydrochloride (other) in the next 90 days

sole-source market · price up 5% YoY

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 3 across plans
  • Costs ≥ $950/fill · avg $735.76 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Brixadi

Regulatory

Application
NDA207932
TE code
Approval date
Oct 23, 2015
Patents / exclusivity
21 patents, 0 exclusivities
TypeNumber / codeExpires
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent9901539Dec 21, 2032
patent8147866Jul 23, 2027
patent8147866Jul 23, 2027
patent8147866Jul 23, 2027
patent9655843Jul 23, 2027
patent9655843Jul 23, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.
  • Class II · TerminatedMar 15, 2021
    Cardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Manufacturers of buprenorphine hydrochloride (Film, Soluble)

LabelerStrengthFirst seenLast seen
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 150 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 300 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 450 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 600 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 75 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 750 ug/1Jul 15, 2026Sep 2, 2026
BioDelivery Sciences International IncBUPRENORPHINE HYDROCHLORIDE 900 ug/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Belbuca — NDC 59385-0026-60," retrieved September 3, 2026, https://drugdashboards.com/drug/59385002660.

Free to cite with attribution — see how the data is put together.