DrugDashboards

Orkambi

lumacaftor and ivacaftor · LUMACAFTOR 100 mg/1; IVACAFTOR 125 mg/1 · Tablet, Film Coated · Oral · Vertex Pharmaceuticals Incorporated

NDC 51167-0700-02 · 4 CARTON in 1 BOX / 7 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK · NDA · View full market →

The short version

Just 2 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)$202.15per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$211.63per unitnegotiated price across 4,230 plans — before rebates · Apr 1, 2026
  • Federal ceiling (Big4)$156.90per unitVertex Pharmaceuticals, Inc. · Jan 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
$211.63per unit
middle half $207.21$216.43 · 4,230 plans · Apr 1, 2026
Est. net of rebates
$126.98–$158.72
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
77%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · qty limit 94%

*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

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

Estimated fill cost

WAC per package, as filed
$23,238.98
Reported to Texas DSHS · 2026 annual filing · Vertex Pharmaceuticals Incorporated

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

Medicaid spend (2025)

$441,728
19 prescriptions paid by Medicaid nationally · all Medicaid spend →

Supply fragility

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

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 5 across plans
  • Costs ≥ $950/fill · avg $22,640.42 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA206038
TE code
Approval date
Jul 2, 2015
Patents / exclusivity
90 patents, 0 exclusivities
TypeNumber / codeExpires
patent8993600*PEDJun 11, 2031
patent8993600*PEDJun 11, 2031
patent8507534*PEDMar 20, 2031
patent8716338*PEDMar 20, 2031
patent8507534*PEDMar 20, 2031
patent8716338*PEDMar 20, 2031
patent8993600Dec 11, 2030
patent8993600Dec 11, 2030
patent8716338Sep 20, 2030
patent8507534Sep 20, 2030
patent8716338Sep 20, 2030
patent8507534Sep 20, 2030

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of lumacaftor and ivacaftor (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Aesica Queenborough LimitedLUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1Aug 20, 2026Sep 3, 2026
Vertex Pharmaceuticals IncorporatedLUMACAFTOR 200 mg/1; IVACAFTOR 125 mg/1Aug 26, 2026Sep 2, 2026
Vertex Pharmaceuticals IncorporatedLUMACAFTOR 100 mg/1; IVACAFTOR 125 mg/1Aug 26, 2026Sep 2, 2026
Aesica Queenborough LimitedLUMACAFTOR 125 mg/1; IVACAFTOR 200 mg/1Jul 22, 2026Aug 19, 2026
Vertex Pharmaceuticals IncorporatedLUMACAFTOR 125 mg/1; IVACAFTOR 100 mg/1Jul 22, 2026Aug 19, 2026
Vertex Pharmaceuticals IncorporatedLUMACAFTOR 125 mg/1; IVACAFTOR 200 mg/1Jul 22, 2026Aug 19, 2026
Aesica Queenborough LimitedIVACAFTOR 125 mg/1; LUMACAFTOR 200 mg/1Jul 15, 2026Jul 15, 2026
Vertex Pharmaceuticals IncorporatedIVACAFTOR 125 mg/1; LUMACAFTOR 200 mg/1Jul 15, 2026Jul 15, 2026
Vertex Pharmaceuticals IncorporatedIVACAFTOR 125 mg/1; LUMACAFTOR 100 mg/1Jul 15, 2026Jul 15, 2026

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

Cite this page

DrugDashboards, "Orkambi — NDC 51167-0700-02," retrieved September 3, 2026, https://drugdashboards.com/drug/51167070002.

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