Prescription medicine
Glatiramer Brand names: Copaxone, Glatopa
Glatiramer (Copaxone) is a prescription medicine with an FDA approval on record since 1996. FDA's NDC Directory lists it from 8 generic labelers, and pharmacies paid $86.10 per mL (Glatiramer 40 mg/mL syringe) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the glatiramer FDA label on DailyMed (effective June 23, 2026, Teva Neuroscience, Inc.); the NDA 20622 record on Drugs@FDA; every glatiramer label on DailyMed.
Highlights of the record
FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
ANAPHYLACTIC REACTIONS.
Cases of life-threatening and fatal anaphylaxis have been reported with COPAXONE. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions ( 5.1 )]. COPAXONE is contraindicated in patients with a history of hypersensitivity reactions to COPAXONE, including anaphylaxis. If an anaphylactic reaction occurs, treatment with COPAXONE must be immediately discontinued. Unless a clear alternative etiology is identified, COPAXONE must be permanently discontinued [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: ANAPHYLACTIC REACTIONS See full prescribing information for complete boxed warning. Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving COPAXONE. Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. […]
Used for
From the label: indications and usageCOPAXONE 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.
Forms and strengths
- 20 mg/ml
- 40 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- December 20, 1996 Copaxone, Teva Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first April 16, 2015; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $86.10 per mL Glatiramer 40 mg/mL syringe
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2012 0 Class I among all firms' recalls; latest April 3, 2018
- FAERS reports
- 62,165 through July 30, 2026
What is glatiramer used for?
From the label: indications and usageCOPAXONE 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 ( 1 ).
Conditions named in the indications of glatiramer's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Copaxone), Teva Neuroscience, Inc., effective June 23, 2026 (SPL set aa88f583-4f5f-433b-80b4-1f4c9fb28357), via openFDA; the full label on DailyMed
What does the patient leaflet for glatiramer say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about COPAXONE?Serious allergic reactions (anaphylactic reactions). Serious allergic reactions that may be life-threatening or lead to death may happen any time after you start using COPAXONE. These reactions may happen right after your first dose up to years after starting treatment with COPAXONE, even if you never had an allergic reaction before. Many reactions have happened within 1 hour of using COPAXONE. Some signs and symptoms may be the same as those of an immediate post-injection reaction. See What are the possible side effects of COPAXONE? Stop using COPAXONE and get emergency help right away if you have: widespread rash swelling of the face, eyelids, lips, mouth, throat, or tongue sudden shortness of breath, difficulty breathing, or wheezing uncontrolled shaking (convulsions) trouble swallowing or speaking fainting, feeling dizzy or faint
From the patient leaflet: How should I store COPAXONE?Store COPAXONE in the refrigerator between 36°F to 46°F (2°C to 8°C). When you are not able to refrigerate COPAXONE, you may store it for up to 1 month at room temperature between 59°F to 86°F (15°C to 30°C). Protect COPAXONE from light or high temperature. Do not freeze COPAXONE syringes. If a syringe freezes, throw it away in a sharps disposal container. See Step 13 in the Instructions for Use, “Dispose of your needles and syringes”. Keep COPAXONE and all medicines out of the reach of children.
Source: FDA drug label (Copaxone), Teva Neuroscience, Inc., effective June 23, 2026 (SPL set aa88f583-4f5f-433b-80b4-1f4c9fb28357), via openFDA; the full label on DailyMed
Is there a generic for glatiramer (Copaxone)?
The FDA approved the first generic glatiramer on April 16, 2015. 10 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists glatiramer from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1996 earliest approval on file
- 2015 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for glatiramer (Copaxone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $86.10 per mL (Glatiramer 40 mg/mL syringe), down 20% from $106.94 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Glatiramer 20 mg/mL syringe (generic)
- Copaxone 20 mg/mL syringe (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Glatiramer 20 mg/mL syringe | Generic | $41.76 per mL | n/a | -14% |
| Glatiramer 40 mg/mL syringe | Generic | $86.10 per mL | n/a | -20% |
| Glatopa 20 mg/mL syringe | Generic | $41.76 per mL | n/a | -14% |
| Glatopa 40 mg/mL syringe | Generic | $86.10 per mL | n/a | -20% |
| Copaxone 20 mg/mL syringe | Brand | $229.80 per mL | n/a | +0.3% |
| Copaxone 40 mg/mL syringe | Brand | $541.12 per mL | n/a | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has glatiramer been recalled?
The FDA's Enforcement Report lists 4 recalls naming glatiramer since 2012: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 3, 2018 | Class II | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. |
| October 24, 2013 | Class II | 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. |
| December 5, 2012 | Class II | 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 … |
| May 18, 2012 | Class II | 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. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the glatiramer label say about other medicines?
The glatiramer label names no other medicine on this site. The labels of 4 other medicines name glatiramer. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name glatiramer
Source: FDA drug label (Copaxone), Teva Neuroscience, Inc., effective June 23, 2026 (SPL set aa88f583-4f5f-433b-80b4-1f4c9fb28357), via openFDA; the full label on DailyMed
What do FAERS reports show for glatiramer?
The FDA Adverse Event Reporting System holds 62,165 reports that list glatiramer among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,316 are coded as a death and 9,712 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as glatiramer?
4 other medicines are given the same way (subcutaneous) and in the same FDA class as glatiramer or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Interferon beta 1a | Multiple sclerosis | none listed | $1,848.67 per mL 44 mcg/0.5 mL | No current entry |
| Peginterferon beta 1a | Multiple sclerosis | none listed | n/a | No current entry |
| Corticotropin | Multiple sclerosis | none listed | n/a | No current entry |
| Ofatumumab | Multiple sclerosis | none listed | $24,369.37 per mL 20 mg/0.4 mL pen | No current entry |
Every medicine labeled for the same conditions as glatiramer
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to glatiramer
- 4 medicines for the same use
- Glatiramer side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other