DrugDashboards

Copiktra

duvelisib · DUVELISIB 15 mg/1 · Capsule · Oral · Secura Bio, Inc

NDC 73116-0215-56 · 56 CAPSULE in 1 PACKAGE · NDA · View full market →

The short version

Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Curia New York, Inc., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.

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)$468.26per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$501.91per unitnegotiated price across 5,496 plans — before rebates · Apr 1, 2026
  • List price (WAC, as filed)$28,008.21per packageSecura Bio, Inc. · Oct 1, 2024

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
$501.91per unit
middle half $487.90$521.69 · 5,496 plans · Apr 1, 2026
Est. net of rebates
$301.14–$376.43
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 98% · step therapy 0% · 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

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

Estimated fill cost

WAC per package, as filed
$28,008.21
Reported to Texas DSHS · 2026 annual filing · Secura Bio, Inc.

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

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 3 of 6 public criteria. Why that matters →

  • Part D specialty tier · median tier 5 across plans
  • Costs ≥ $950/fill · avg $36,736.35 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program · Copiktra

Regulatory

Application
NDA211155
TE code
Approval date
Sep 24, 2018
Patents / exclusivity
12 patents, 0 exclusivities
TypeNumber / codeExpires
patent12213983Apr 26, 2035
patent12213983Apr 26, 2035
patent8193182Sep 24, 2032
patent8193182Sep 24, 2032
patentRE46621May 17, 2032
patentRE46621May 17, 2032
patent11312718Jan 10, 2032
patent9840505Jan 10, 2032
patent9840505Jan 10, 2032
patent11312718Jan 10, 2032
patent9216982Jan 5, 2029
patent9216982Jan 5, 2029

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of duvelisib (Capsule)

LabelerStrengthFirst seenLast seen
Catalent Pharma Solutions, LLCDUVELISIB 15 mg/1Jul 15, 2026Sep 2, 2026
Catalent Pharma Solutions, LLCDUVELISIB 25 mg/1Jul 15, 2026Sep 2, 2026
Secura Bio, IncDUVELISIB 15 mg/1Jul 15, 2026Sep 2, 2026
Secura Bio, IncDUVELISIB 25 mg/1Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Copiktra — NDC 73116-0215-56," retrieved September 3, 2026, https://drugdashboards.com/drug/73116021556.

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