DrugDashboards

Lybalvi

olanzapine and samidorphan L-malate · OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg/1 · Tablet, Film Coated · Oral · Alkermes, Inc.

NDC 65757-0654-42 · 1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE · 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 $55.05 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)$55.05per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$53.62per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$55.10per unitnegotiated price across 2,570 plans — before rebates · Apr 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
$55.10per unit
middle half $54.73$55.82 · 2,570 plans · Apr 1, 2026
Est. net of rebates
$33.06–$41.33
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
47%of plans cover it
tier 5 · prior auth 59% · step therapy 5% · qty limit 93%

*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$20.00$40.00$60.00Apr 2022Sep 2026$55.05
25 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$1651.43
#90 count
$4954.28

Estimates: latest NADAC unit price × quantity. Pharmacy acquisition cost only — excludes dispensing fees, markup, and insurance terms.

Medicaid spend (2025)

$56.8M
36,992 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 olanzapine and samidorphan l-malate (oral solid) in the next 90 days

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $1,623.45 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Zyprexa Relprevv

Regulatory

Application
NDA213378
TE code
Approval date
May 28, 2021
Patents / exclusivity
56 patents, 4 exclusivities
TypeNumber / codeExpires
exclusivityNCEMay 28, 2026
exclusivityNCEMay 28, 2026
exclusivityNCEMay 28, 2026
exclusivityNCEMay 28, 2026
patent12390474Nov 12, 2041
patent11951111Nov 12, 2041
patent11951111Nov 12, 2041
patent11951111Nov 12, 2041
patent11951111Nov 12, 2041
patent12390474Nov 12, 2041
patent11707466Nov 12, 2041
patent12390474Nov 12, 2041

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of olanzapine and samidorphan L-malate (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Alkermes, Inc.OLANZAPINE 15 mg/1; SAMIDORPHAN L-MALATE 10 mg/1Jul 15, 2026Sep 3, 2026
Alkermes, Inc.OLANZAPINE 5 mg/1; SAMIDORPHAN L-MALATE 10 mg/1Jul 15, 2026Sep 3, 2026
Alkermes, Inc.OLANZAPINE 20 mg/1; SAMIDORPHAN L-MALATE 10 mg/1Jul 15, 2026Aug 31, 2026
Alkermes, Inc.OLANZAPINE 10 mg/1; SAMIDORPHAN L-MALATE 10 mg/1Jul 15, 2026Aug 28, 2026

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

Cite this page

DrugDashboards, "Lybalvi — NDC 65757-0654-42," retrieved September 3, 2026, https://drugdashboards.com/drug/65757065442.

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