DrugDashboards

Zenpep

pancrelipase lipase, pancrelipase protease, pancrelipase amylase · PANCRELIPASE LIPASE 60000 [USP'U]/1; PANCRELIPASE PROTEASE 189600 [USP'U]/1; PANCRELIPASE AMYLASE 252600 [USP'U]/1 · Capsule, Delayed Release · Oral · Aimmune Therapeutics, Inc.

NDC 73562-0117-01 · 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE · BLA · 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 $24.34 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)$24.34per EAinvoice-surveyed acquisition cost · Aug 19, 2026
  • Part D plans paid (avg)$11.15per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$24.67per unitnegotiated price across 5,153 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
$24.67per unit
middle half $24.12$25.61 · 5,153 plans · Apr 1, 2026
Est. net of rebates
$14.80–$18.50
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
94%of plans cover it
tier 4 · prior auth 0% · step therapy 0% · qty limit 0%

*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$20.00$30.00Jun 2024Sep 2026$24.34
20 price points · per EASource: CMS NADAC

Estimated fill cost

#30 count
$730.33
#90 count
$2190.98

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

Medicaid spend (2025)

$14.8M
3,919 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 pancrelipase lipase, pancrelipase protease, pancrelipase amylase (oral solid) in the next 90 days

sole-source market · price up 4% 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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 4 across plans
  • Costs ≥ $950/fill · avg $2,305.26 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
BLA022210
TE code
Approval date
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of pancrelipase lipase, pancrelipase protease, pancrelipase amylase (Capsule, Delayed Release)

LabelerStrengthFirst seenLast seen
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 10000 [USP'U]/1; PANCRELIPASE PROTEASE 32000 [USP'U]/1; PANCRELIPASE AMYLASE 42000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 60000 [USP'U]/1; PANCRELIPASE PROTEASE 189600 [USP'U]/1; PANCRELIPASE AMYLASE 252600 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 5000 [USP'U]/1; PANCRELIPASE PROTEASE 17000 [USP'U]/1; PANCRELIPASE AMYLASE 24000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 40000 [USP'U]/1; PANCRELIPASE PROTEASE 126000 [USP'U]/1; PANCRELIPASE AMYLASE 168000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 3000 [USP'U]/1; PANCRELIPASE PROTEASE 10000 [USP'U]/1; PANCRELIPASE AMYLASE 14000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 25000 [USP'U]/1; PANCRELIPASE PROTEASE 79000 [USP'U]/1; PANCRELIPASE AMYLASE 105000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 20000 [USP'U]/1; PANCRELIPASE PROTEASE 63000 [USP'U]/1; PANCRELIPASE AMYLASE 84000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 15000 [USP'U]/1; PANCRELIPASE PROTEASE 47000 [USP'U]/1; PANCRELIPASE AMYLASE 63000 [USP'U]/1Aug 26, 2026Sep 2, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 84000 [USP'U]/1; PANCRELIPASE PROTEASE 20000 [USP'U]/1; PANCRELIPASE AMYLASE 63000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 105000 [USP'U]/1; PANCRELIPASE PROTEASE 25000 [USP'U]/1; PANCRELIPASE AMYLASE 79000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 14000 [USP'U]/1; PANCRELIPASE PROTEASE 3000 [USP'U]/1; PANCRELIPASE AMYLASE 10000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 168000 [USP'U]/1; PANCRELIPASE PROTEASE 40000 [USP'U]/1; PANCRELIPASE AMYLASE 126000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 24000 [USP'U]/1; PANCRELIPASE PROTEASE 5000 [USP'U]/1; PANCRELIPASE AMYLASE 17000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 252600 [USP'U]/1; PANCRELIPASE PROTEASE 60000 [USP'U]/1; PANCRELIPASE AMYLASE 189600 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 42000 [USP'U]/1; PANCRELIPASE PROTEASE 10000 [USP'U]/1; PANCRELIPASE AMYLASE 32000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE LIPASE 63000 [USP'U]/1; PANCRELIPASE PROTEASE 15000 [USP'U]/1; PANCRELIPASE AMYLASE 47000 [USP'U]/1Jul 22, 2026Aug 19, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 14000 [USP'U]/1; PANCRELIPASE LIPASE 3000 [USP'U]/1; PANCRELIPASE PROTEASE 10000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 252600 [USP'U]/1; PANCRELIPASE LIPASE 60000 [USP'U]/1; PANCRELIPASE PROTEASE 189600 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 24000 [USP'U]/1; PANCRELIPASE LIPASE 5000 [USP'U]/1; PANCRELIPASE PROTEASE 17000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 84000 [USP'U]/1; PANCRELIPASE LIPASE 20000 [USP'U]/1; PANCRELIPASE PROTEASE 63000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 105000 [USP'U]/1; PANCRELIPASE LIPASE 25000 [USP'U]/1; PANCRELIPASE PROTEASE 79000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 63000 [USP'U]/1; PANCRELIPASE LIPASE 15000 [USP'U]/1; PANCRELIPASE PROTEASE 47000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 168000 [USP'U]/1; PANCRELIPASE LIPASE 40000 [USP'U]/1; PANCRELIPASE PROTEASE 126000 [USP'U]/1Jul 15, 2026Jul 15, 2026
Aimmune Therapeutics, Inc.PANCRELIPASE AMYLASE 42000 [USP'U]/1; PANCRELIPASE LIPASE 10000 [USP'U]/1; PANCRELIPASE PROTEASE 32000 [USP'U]/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Zenpep — NDC 73562-0117-01," retrieved September 3, 2026, https://drugdashboards.com/drug/73562011701.

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