DrugDashboards

Pirfenidone

Pirfenidone · PIRFENIDONE 801 mg/1 · Tablet, Film Coated · Oral · AvKARE

NDC 42291-0492-09 · 1 BOTTLE in 1 CARTON / 90 TABLET, FILM COATED in 1 BOTTLE · ANDA · View full market →

The short version

12 companies supply this market — deep enough that no single failure threatens the supply.

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)$16.17per dosage unitgross, before rebates — matched by drug name · 2024
  • Federal contracts pay (FSS)$50.36per unitAvKare, LLC · Aug 15, 2025

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00480-3611-98) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.

ⓘ 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
$24.12per unit
middle half $11.71$48.00 · 5,475 plans · Apr 1, 2026
Est. net of rebates
≈ $24.12
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
100%of plans cover it
tier 5 · prior auth 100% · step therapy 0% · qty limit 95%

*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
$5,214.61
Reported to Texas DSHS · 2026 annual filing · AvKare

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

Supply fragility

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

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for pirfenidone (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 →

Is this a "specialty" drug?

There's no legal definition — it meets 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $2,218.82 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA212570
TE code
AB
Approval date
Mar 25, 2022
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 Pirfenidone (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
Amneal Pharmaceuticals NY LLCPIRFENIDONE 267 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.PIRFENIDONE 267 mg/1Jul 15, 2026Sep 3, 2026
Teva Pharmaceuticals, Inc.PIRFENIDONE 801 mg/1Jul 15, 2026Sep 3, 2026
Accord Healthcare Inc.PIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Accord Healthcare Inc.PIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.PIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
ANI Pharmaceuticals, Inc.PIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
AvKAREPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
AvKAREPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.PIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Camber Pharmaceuticals, Inc.PIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedPIRFENIDONE 534 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Laurus Labs LimitedPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Major PharmaceuticalsPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Micro Labs LimitedPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LLCPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Northstar Rx LLCPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Novadoz Pharmaceuticals LLCPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncPIRFENIDONE 801 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncPIRFENIDONE 267 mg/1Jul 15, 2026Sep 2, 2026
Amneal Pharmaceuticals NY LLCPIRFENIDONE 801 mg/1Jul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Pirfenidone — NDC 42291-0492-09," retrieved September 3, 2026, https://drugdashboards.com/drug/42291049209.

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