Quick answers
- What is Glatiramer acetate used for?
- The FDA-approved label (Copaxone, Teva Neuroscience, Inc., June 23, 2026) says: “COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Glatiramer acetate have a boxed warning?
- Yes. The FDA label for Copaxone has a boxed warning (“WARNING: ANAPHYLACTIC REACTIONS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Glatiramer acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Glatiramer acetate been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started October 24, 2013 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Glatiramer acetate?
- 9 companies list prescription products of Glatiramer acetate in the FDA NDC Directory, including Italfarmaco SpA, Mylan Pharmaceuticals Inc. and Sandoz Inc.
What Glatiramer acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. COPAXONE is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
— FDA label: Copaxone, Teva Neuroscience, Inc., effective June 23, 2026. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: ANAPHYLACTIC REACTIONS
. Read it on the full label →
9 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| glatiramer acetate 20 mg/mL injection, solution | Generic | $39.67 per mL |
| glatiramer acetate 20 mg/mL injection, solution | Brand: Copaxone | $229.80 per mL |
| glatiramer acetate 40 mg/mL injection, solution | Generic | $82.23 per mL |
| glatiramer acetate 40 mg/mL injection, solution | Brand: Copaxone | $541.47 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Italfarmaco SpA2 products
- Mylan Pharmaceuticals Inc.2 products
- Sandoz Inc2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Teva Neuroscience, Inc.2 products
- Upsher-Smith Laboratories, LLC2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Bryant Ranch Prepack2 products
- Ajenat Pharmaceuticals LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020622 COPAXONE | Teva Pharms USA | December 20, 1996 | 52, latest June 22, 2026 2026: Labeling · 2025: Labeling · 2025: Labeling |
Generic approvals (10)
- ANDA090218Sandoz · April 16, 2015
- ANDA091646Mylan · October 3, 2017
- ANDA206936Mylan · October 3, 2017
- ANDA206921Sandoz · February 12, 2018
- ANDA203857Synthon Bv · September 25, 2024
- ANDA206873Synthon Bv · September 25, 2024
- ANDA208468Chemi Spa · May 7, 2025
- ANDA214741Scinopharm Taiwan · December 31, 2025
- ANDA213382Hybio · February 11, 2026
- ANDA214022Hybio · February 11, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 24, 2013 · Class II · Terminated · D-001-2014
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas C — Teva Pharmaceuticals USA
-
December 5, 2012 · Class II · Terminated · D-249-2013
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.
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA P — Teva Pharmaceuticals USA, Inc.
-
May 18, 2012 · Class II · Terminated · D-1442-2012
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 — Teva Pharmaceuticals USA, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Copaxone, Teva Neuroscience, Inc., effective June 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →