DrugDashboards

Leuprolide Acetate Depot

leuprolide acetate · Kit · Cipla Usa Inc.

NDC 69097-0909-50 · 1 KIT in 1 CARTON * 2 mL in 1 VIAL, SINGLE-DOSE * 2 mL in 1 SYRINGE · NDA · View full market →

The short version

15 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.

  • Medicare Part B pays (ASP+6%)$687.29per billing unit (7.5 MG)HCPCS J1954 · Jul 1, 2026
  • Part D plans paid (avg)$1,326.18per dosage unitgross, before rebates — matched by drug name · 2024
  • Part D point of sale (median)$1,320.46per unitnegotiated price across 2,352 plans — before rebates · Apr 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
$1,320.46per unit
middle half $1,275.98$1,456.56 · 2,352 plans · Apr 1, 2026
Est. net of rebates
$792.27–$990.34
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
43%of plans cover it
tier 4 · prior auth 91% · step therapy 0% · qty limit 60%

*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
$1,355.07
Reported to Texas DSHS · 2025 annual filing · Cipla USA Inc.

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

Medicare Part B (ASP)

Payment limit per 7.5 MG
$687.287
HCPCS J1954 · Jul 1, 2026 quarter · typically ASP + 6%

Medicaid spend (2024)

$16,518
28 prescriptions paid by Medicaid nationally · all Medicaid spend →

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 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 →

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 · median tier 4 across plans
  • Costs ≥ $950/fill · avg $4,304.03 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA205054
TE code
Approval date
Aug 28, 2018
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 Depot — NDC 69097-0909-50," retrieved September 3, 2026, https://drugdashboards.com/drug/69097090950.

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