DrugDashboards

Bylvay

odevixibat · ODEVIXIBAT 400 ug/1 · Capsule, Coated Pellets · Oral · Albireo Pharma, Inc.

NDC 74528-0040-01 · 1 BOTTLE in 1 CARTON / 30 CAPSULE, COATED PELLETS in 1 BOTTLE · NDA · View full market →

The short version

Just 3 companies supply this market — thin enough that a single exit would be felt immediately.

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.

  • Part D plans paid (avg)$990.50per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$541.76per unitnegotiated price across 1,019 plans — before rebates · Apr 1, 2025

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
$541.76per unit
middle half $541.76$541.76 · 1,019 plans · Apr 1, 2025
Est. net of rebates
$325.05–$406.32
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 6 quarters since 2024.

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Estimated fill cost

WAC per package, as filed
$14,480.00
Reported to Texas DSHS · 2025 annual filing · Ipsen Biopharmaceuticals

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

Medicaid spend (2025)

$288,620
12 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $123,160.93 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA215498
TE code
Approval date
Jul 20, 2021
Patents / exclusivity
64 patents, 16 exclusivities
TypeNumber / codeExpires
exclusivityODE-436Jun 13, 2030
exclusivityODE-436Jun 13, 2030
exclusivityODE-436Jun 13, 2030
exclusivityODE-436Jun 13, 2030
exclusivityODE-363Jul 20, 2028
exclusivityODE-363Jul 20, 2028
exclusivityODE-363Jul 20, 2028
exclusivityODE-363Jul 20, 2028
exclusivityNCEJul 20, 2026
exclusivityNCEJul 20, 2026
exclusivityNCEJul 20, 2026
exclusivityNCEJul 20, 2026

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of odevixibat (Capsule, Coated Pellets)

LabelerStrengthFirst seenLast seen
Albireo Pharma, Inc.ODEVIXIBAT 1200 ug/1Jul 15, 2026Sep 2, 2026
Albireo Pharma, Inc.ODEVIXIBAT 200 ug/1Jul 15, 2026Sep 2, 2026
Albireo Pharma, Inc.ODEVIXIBAT 400 ug/1Jul 15, 2026Sep 2, 2026
Albireo Pharma, Inc.ODEVIXIBAT 600 ug/1Jul 15, 2026Sep 2, 2026
Ipsen Biopharmaceuticals, Inc.ODEVIXIBAT 600 ug/1Jul 15, 2026Sep 2, 2026
Ipsen Biopharmaceuticals, Inc.ODEVIXIBAT 200 ug/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SODEVIXIBAT 200 ug/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SODEVIXIBAT 400 ug/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SODEVIXIBAT 1200 ug/1Jul 15, 2026Sep 2, 2026
Patheon France S.A.SODEVIXIBAT 600 ug/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Bylvay — NDC 74528-0040-01," retrieved September 3, 2026, https://drugdashboards.com/drug/74528004001.

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