DrugDashboards

Otrexup

methotrexate · METHOTREXATE 25 mg/.4mL · Injection, Solution · Subcutaneous · Antares Pharma, Inc.

NDC 54436-0025-01 · 1 SYRINGE in 1 CARTON / .4 mL in 1 SYRINGE · NDA · View full market →

The short version

7 companies supply this market — a reasonable cushion if one runs into trouble. It is in shortage right now — FDA lists the reason as “other”.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 54436-0025-04) — 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ⓘ
$473.81per unit
middle half $448.43–$478.49 · 44 plans · Oct 1, 2025
Est. net of rebatesⓘ
$284.28–$355.35
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
1%of plans cover it
tier 4 · prior auth 86% · step therapy 0% · qty limit 45%

*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 8 quarters since 2024.

NADAC price per unit

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

Supply fragility

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

90-day shortage risk (model v2)

0.4%chance of a new FDA shortage posting for methotrexate (injectable) in the next 90 days

sterile injectable · sole-source market · price up 1% YoY

For scale: the typical drug’s chance is about 0.1% — this one is 3× that.

Backtested statistical model over the whole market, not this package alone. Model details →

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 1 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $944.17 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA204824
TE code
—
Approval date
Oct 11, 2013
Patents / exclusivity
120 patents, 0 exclusivities
TypeNumber / codeExpires
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8814834May 27, 2031
patent8480631Mar 19, 2030
patent8945063Mar 19, 2030
patent8945063Mar 19, 2030
patent8480631Mar 19, 2030

Shortage history

  • In shortage now — Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01)Mar 13, 2023
    Other
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01)Mar 13, 2023
    Other
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-41)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-10)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months
  • In shortage now — Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-38)Mar 13, 2023
    month 42 — 2× the typical 20-month injectable shortage · model puts 35% odds it resolves within 6 months

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of methotrexate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Alembic Pharmaceuticals Inc.METHOTREXATE SODIUM 25 mg/mLJul 15, 2026Sep 3, 2026
Alembic Pharmaceuticals LimitedMETHOTREXATE SODIUM 25 mg/mLJul 15, 2026Sep 3, 2026
Hospira, Inc.METHOTREXATE SODIUM 25 mg/mLJul 15, 2026Sep 3, 2026
Antares Pharma, Inc.METHOTREXATE 25 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 10 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 12.5 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 17.5 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 15 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 20 mg/.4mLJul 15, 2026Sep 2, 2026
Antares Pharma, Inc.METHOTREXATE 22.5 mg/.4mLJul 15, 2026Sep 2, 2026
Eugia US LLCMETHOTREXATE SODIUM 200 mg/8mLJul 15, 2026Sep 2, 2026
Eugia US LLCMETHOTREXATE SODIUM 250 mg/10mLJul 15, 2026Sep 2, 2026
Eugia US LLCMETHOTREXATE SODIUM 100 mg/4mLJul 15, 2026Sep 2, 2026
Eugia US LLCMETHOTREXATE SODIUM 50 mg/2mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 7.5 mg/.15mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 10 mg/.2mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 12.5 mg/.25mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 15 mg/.3mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 17.5 mg/.35mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 20 mg/.4mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 22.5 mg/.45mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 25 mg/.5mLJul 15, 2026Sep 2, 2026
Medexus Pharma Inc.METHOTREXATE SODIUM 30 mg/.6mLJul 15, 2026Sep 2, 2026
Teva Parenteral Medicines, Inc.METHOTREXATE SODIUM 25 mg/mLJul 15, 2026Aug 31, 2026

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

Cite this page

DrugDashboards, "Otrexup — NDC 54436-0025-01," retrieved September 3, 2026, https://drugdashboards.com/drug/54436002501.

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