DrugDashboards

Leuprolide Acetate

Leuprolide Acetate · Kit · Subcutaneous · NorthStar RxLLC

NDC 72603-0344-01 · 1 KIT in 1 CARTON * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET · ANDA · View full market →

The short version

15 companies supply this market — deep enough that no single failure threatens the supply. The generic price has fallen 32% in a year, to $205.71 per unit — and generics that get this cheap tend to get abandoned rather than defended. The brand (Lupron Depot) runs $3802.55 per unit 19× more. Put together: this looks like a healthy supply — the boring kind, which is exactly what you want.

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.

  • Pharmacies pay (NADAC)$205.71per EAinvoice-surveyed acquisition cost · Apr 22, 2026
  • Part D plans paid (avg)$344.33per dosage unitgross, before rebates — matched by drug name · 2024

Medicare Part D

All Part D pricing →

Matched to CMS's representative package for this drug (NDC 00781-4003-32) — 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
$407.34per unit
middle half $347.43$596.58 · 5,412 plans · Apr 1, 2026
Est. net of rebates
≈ $407.34
generic — rebates are minimal, so net ≈ gross
Coverage & restrictions
98%of plans cover it
tier 4 · prior auth 75% · step therapy 0% · qty limit 24%

*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

$0$200.00$400.00Jul 2024Sep 2026$205.71
18 price points · per EA · held since Invalid DateSource: CMS NADAC

Estimated fill cost

WAC per package, as filed
$710.00
Reported to Texas DSHS · 2026 annual filing · Northstar Rx Llc

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

Supply fragility

8Low risk

Some pressure is visible, but not much — here’s everything the score found to count.

  • price down 32% year over year+8

The score counts pressure that is already visible — fewer makers, shortages, recalls, falling prices. 0 means none of it; 100 means all of it at once. Recomputed daily · as of Sep 3, 2026

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for leuprolide acetate (other) in the next 90 days

OAI inspection at a producing facility (24 months) · 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 $941.18 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA213829
TE code
AP
Approval date
Aug 13, 2021
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 Leuprolide Acetate (Kit)

LabelerStrengthFirst seenLast seen
AbbVie Inc.Jul 15, 2026Sep 3, 2026
TOLMAR Inc.Jul 15, 2026Sep 3, 2026
Amneal Pharmaceuticals LLCJul 15, 2026Sep 2, 2026
Avyxa Pharma, LLCJul 15, 2026Sep 2, 2026
Cipla Usa Inc.Jul 15, 2026Sep 2, 2026
Eugia US LLCJul 15, 2026Sep 2, 2026
Meitheal Pharmaceuticals IncJul 15, 2026Sep 2, 2026
NorthStar RxLLCJul 15, 2026Sep 2, 2026
PAI Holdings, LLC dba PAI PharmaJul 15, 2026Sep 2, 2026
Sandoz IncJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.Jul 15, 2026Sep 2, 2026
UBI Pharma Inc.Jul 15, 2026Sep 2, 2026
VGYAAN Pharmaceuticals LLCJul 15, 2026Sep 2, 2026
Zydus Lifesciences LimitedJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.Jul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Leuprolide Acetate — NDC 72603-0344-01," retrieved September 3, 2026, https://drugdashboards.com/drug/72603034401.

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