DrugDashboards

Amitiza

lubiprostone · LUBIPROSTONE 24 ug/1 · Capsule, Gelatin Coated · Oral · Takeda Pharmaceuticals America, Inc.

NDC 64764-0240-60 · 60 CAPSULE, GELATIN COATED in 1 BOTTLE · NDA · View full market →

The short version

16 companies supply this market — deep enough that no single failure threatens the supply. The brand price has held steady around $5.95 per unit over the past year. Generic versions run $0.5866 per unit11× cheaper. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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)$5.95per EAinvoice-surveyed acquisition cost · Feb 19, 2025
  • Part D plans paid (avg)$5.65per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$5.87per unitnegotiated price across 10 plans — before rebates · Apr 1, 2024
  • Medicaid generic ceiling (FUL)$1.24per TABweighted avg manufacturer price $0.5306 · Dec 1, 202321% of what pharmacies pay — a deeper discount than 95% of drugs with this benchmark

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
$5.87per unit
middle half $5.87$5.90 · 10 plans · Apr 1, 2024
Est. net of rebates
$3.52–$4.40
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
of plans cover it

*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 2 quarters since 2024.

NADAC price per unit

$0$2.00$4.00$6.00Oct 2013Feb 2025$5.95
24 price points · per EA · last surveyed Invalid Date · dashed = manufacturer avg (WAMP)Source: CMS NADAC

Estimated fill cost

#30 count
$178.50
#90 count
$535.49

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

Medicaid spend (2025)

$24,798
67 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

0Low risk

Nothing here is signaling trouble: several manufacturers, no current shortage, no recent serious recalls, stable pricing. In drug supply, boring is the good outcome.

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 lubiprostone (oral solid) in the next 90 days

sole-source market

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 →

Regulatory

Application
NDA021908
TE code
AB
Approval date
Jan 31, 2006
Patents / exclusivity
6 patents, 0 exclusivities
TypeNumber / codeExpires
patent8026393Oct 25, 2027
patent8026393Oct 25, 2027
patent8779187Jan 23, 2027
patent8779187Jan 23, 2027
patent8338639Jan 23, 2027
patent8338639Jan 23, 2027

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedMay 13, 2019
    MALLINCKRODT PHARMACEUTICALSLabeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
  • Class II · TerminatedMay 13, 2019
    MALLINCKRODT PHARMACEUTICALSLabeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
  • Class III · TerminatedNov 6, 2018
    Takeda Development Center Americas, Inc.Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.

Manufacturers of lubiprostone (Capsule, Gelatin Coated)

LabelerStrengthFirst seenLast seen
Proficient Rx LPLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 3, 2026
SpecGx LLCLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 3, 2026
Advanced Rx of Tennessee, LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Advanced Rx of Tennessee, LLCLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
American Health PackagingLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
American Health PackagingLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.LUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Asclemed USA, Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Direct RxLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Direct_RxLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Dr. Reddy's Laboratories Inc.LUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Golden State Medical Supply, Inc.LUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Natco Pharma USA LLCLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Natco Pharma USA LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Par Health USA, LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Proficient Rx LPLUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Quality Care Products, LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.LUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Takeda Pharmaceuticals America, Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.LUBIPROSTONE 8 ug/1Jul 15, 2026Sep 2, 2026
Teva Pharmaceuticals, Inc.LUBIPROSTONE 24 ug/1Jul 15, 2026Sep 2, 2026
SpecGx LLCLUBIPROSTONE 24 ug/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Amitiza — NDC 64764-0240-60," retrieved September 3, 2026, https://drugdashboards.com/drug/64764024060.

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