DrugDashboards

Copaxone

Glatiramer Acetate · GLATIRAMER ACETATE 40 mg/mL · Injection, Solution · Subcutaneous · Teva Neuroscience, Inc.

NDC 68546-0325-06 · 6 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS · NDA · View full market →

The short version

8 companies supply this market — a reasonable cushion if one runs into trouble. Historically, drugs in this position went on to a new shortage within 90 days about 0.5% of the time — roughly 3× the typical drug (0.1%).

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 00781-3250-89) — 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ⓘ
$188.64per unit
middle half $130.01–$224.00 · 5,269 plans · Apr 1, 2026
Est. net of rebatesⓘ
$113.18–$141.48
brand drug — est. 25-40% rebate off the price at left
Coverage & restrictions
96%of plans cover it
tier 5 · prior auth 77% · step therapy 0% · qty limit 96%

*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.

Supply fragility

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

90-day shortage risk (model v2)

0.5%chance of a new FDA shortage posting for glatiramer acetate (injectable) in the next 90 days

sterile injectable · 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 3× that.

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 2 of 6 public criteria. Why that matters →

  • Part D specialty tier
  • Costs ≥ $950/fill · avg $6,355.85 per prescription
  • Biologic (BLA)
  • Injectable / infused
  • Orphan-drug exclusivity
  • REMS program

Regulatory

Application
NDA020622
TE code
AP
Approval date
Dec 20, 1996
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · TerminatedOct 24, 2013
    Teva Pharmaceuticals USA — Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
  • Class II · TerminatedDec 5, 2012
    Teva Pharmaceuticals USA, Inc. — Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
  • Class II · TerminatedMay 18, 2012
    Teva Pharmaceuticals USA, Inc. — Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.

Manufacturers of Glatiramer Acetate (Injection, Solution)

LabelerStrengthFirst seenLast seen
Ajenat Pharmaceuticals LlcGLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Ajenat Pharmaceuticals LlcGLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackGLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Bryant Ranch PrepackGLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Italfarmaco SpAGLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Italfarmaco SpAGLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Mylan Pharmaceuticals Inc.GLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncGLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Sandoz IncGLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.GLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Sun Pharmaceutical Industries, Inc.GLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Teva Neuroscience, Inc.GLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026
Teva Neuroscience, Inc.GLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.GLATIRAMER ACETATE 40 mg/mLJul 15, 2026Sep 2, 2026
Zydus Pharmaceuticals USA Inc.GLATIRAMER ACETATE 20 mg/mLJul 15, 2026Sep 2, 2026

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

Cite this page

DrugDashboards, "Copaxone — NDC 68546-0325-06," retrieved September 3, 2026, https://drugdashboards.com/drug/68546032506.

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