DrugDashboards

Lifitegrast

Lifitegrast · LIFITEGRAST 50 mg/mL · For Solution · Ophthalmic · Aurobindo Pharma Limited

NDC 59651-0450-60 · 60 POUCH in 1 CARTON / 5 AMPULE in 1 POUCH / .2 mL in 1 AMPULE · ANDA · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. One of its named manufacturing plants, Eugia Pharma Specialities Limited, 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.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

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)

0.2%chance of a new FDA shortage posting for lifitegrast (other) in the next 90 days

OAI inspection at a producing facility (24 months) · sole-source market · price up 3% YoY

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
  • Costs ≥ $950/fill · avg $1,058.62 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
ANDA215063
TE code
Approval date
Nov 7, 2023
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 Lifitegrast (For Solution)

LabelerStrengthFirst seenLast seen
Aurobindo Pharma LimitedLIFITEGRAST 50 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Lifitegrast — NDC 59651-0450-60," retrieved September 3, 2026, https://drugdashboards.com/drug/59651045060.

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