DrugDashboards

Relistor

Methylnaltrexone bromide · METHYLNALTREXONE BROMIDE 8 mg/.4mL · Injection, Solution · Subcutaneous · Salix Pharmaceuticals, Inc.

NDC 65649-0552-04 · 7 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE · NDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. The price has jumped 55% in a year, to $409.77 per mL — sharp rises like this often mean supply is already tightening. 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)$409.77per MLinvoice-surveyed acquisition cost · Jan 1, 2025
  • Part D plans paid (avg)$52.67per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$489.50per unitnegotiated price across 1,289 plans — before rebates · Apr 1, 2026
  • List price (WAC, as filed)$1,436.68per packageSalix Pharmaceuticals, Inc. · May 11, 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
$489.50per unit
middle half $479.03$502.59 · 1,289 plans · Apr 1, 2026
Est. net of rebates
$293.70–$367.12
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
23%of plans cover it
tier 5 · prior auth 81% · step therapy 16% · qty limit 83%

*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$200.00$400.00$600.00Nov 2014Jan 2025$409.77
14 price points · per ML · last surveyed Jan 1, 2025Source: CMS NADAC

Estimated fill cost

WAC per package, as filed
$1,307.26
Reported to Texas DSHS · 2026 annual filing · Salix Pharmaceuticals

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

Medicaid spend (2025)

$174,513
68 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

40Elevated 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
  • sterile injectable+10

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 methylnaltrexone bromide (injectable) in the next 90 days

sterile injectable

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 →

Where it's made

Establishments this product's FDA label declares, located via FDA registration data. How we built this →

Is this a "specialty" drug?

There's no legal definition — it meets 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $2,366.53 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA021964
TE code
Approval date
Apr 24, 2008
Patents / exclusivity
18 patents, 0 exclusivities
TypeNumber / codeExpires
patent8247425Dec 31, 2030
patent8247425Dec 31, 2030
patent8247425Dec 31, 2030
patent8822490Sep 30, 2029
patent8822490Sep 30, 2029
patent9180125Sep 30, 2029
patent9180125Sep 30, 2029
patent9180125Sep 30, 2029
patent9492445Sep 30, 2029
patent8822490Sep 30, 2029
patent9492445Sep 30, 2029
patent9492445Sep 30, 2029

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Methylnaltrexone bromide (Injection, Solution)

LabelerStrengthFirst seenLast seen
Salix Pharmaceuticals, Inc.METHYLNALTREXONE BROMIDE 12 mg/.6mLJul 15, 2026Sep 2, 2026
Salix Pharmaceuticals, Inc.METHYLNALTREXONE BROMIDE 8 mg/.4mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Relistor — NDC 65649-0552-04," retrieved September 3, 2026, https://drugdashboards.com/drug/65649055204.

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