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MedsAcross

Molecule

Glatiramer

Also known as glatiramer acetate
Available on requestOrphanCold chain
Presentations
6
Brands
2
Manufacturers
2
Available from stock
0

Glatiramer is a prescription medicine 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. MedsAcross supplies Glatiramer for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
20 December 1996
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Subcutaneous
Dosage forms
Injection
Identifiers
UNII 5M691HL4BOCAS 28704-27-0DrugBank DB05259Q83053564

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses.

Source: US FDA prescribing information

Dosing overview

For subcutaneous injection only, doses are not interchangeable. COPAXONE 20 mg/mL per day. COPAXONE 40 mg/mL three times per week. Before use, allow the solution to warm to room temperature

Source: US FDA prescribing information

Contraindications

COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis. Known hypersensitivity to glatiramer acetate or mannitol

Source: US FDA prescribing information

Warnings and precautions

Boxed warning (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. Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting. Chest pain, usually transient. Lipoatrophy and skin necrosis may occur. Instruct patients in proper injection technique and to rotate injection sites. COPAXONE can modify immune response. Hepatic Injury: if signs or symptoms of hepatic dysfunction occur, consider discontinuing COPAXONE.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in the labeling: Anaphylactic Reactions Immediate Post-Injection Reaction Chest Pain Lipoatrophy and Skin Necrosis Potential Effects on Immune Response Hepatic Injury In controlled studies of COPAXONE 20 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions, vasodilatation, rash, dyspnea, and chest pain. In a controlled study of COPAXONE 40 mg/mL, most common adverse reactions (≥10% and ≥1.5 times higher than placebo) were: injection site reactions

Source: US FDA prescribing information

Storage

Store COPAXONE refrigerated at 2°C to 8°C (36°F to 46°F). If needed, the patient may store COPAXONE at room temperature, 15°C to 30°C (59°F to 86°F), for up to one month, but refrigeration is preferred. Do not freeze COPAXONE. If a COPAXONE syringe freezes, it should be discarded.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

6 presentations of Glatiramer, sorted by availability.

MedicineManufacturerRegisterAvailability
Glatiramer 20 mg/1 mL injectionSubcutaneous Cold chainGeneric name—US FDAAvailable on request
Glatiramer 40 mg/1 mL injectionSubcutaneous Cold chainGeneric name—US FDAAvailable on request
Glatopa 20 mg/1 mL injectionSubcutaneous Cold chainSandozUS FDAAvailable on request
Glatopa 40 mg/1 mL injectionSubcutaneous Cold chainSandozUS FDAAvailable on request
Copaxone 40 mg/1 mL injectionSubcutaneous Cold chainTeva NeuroscienceUS FDAAvailable on request
Copaxone 20 mg/1 mL injectionSubcutaneous Cold chainTeva NeuroscienceUS FDAAvailable on request

Brands by market

2 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 20 December 1996Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Glatiramer available for export from India?

Yes, on request. MedsAcross lists 6 presentations of Glatiramer and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Glatiramer have?

The catalogue lists 2 brand names for Glatiramer, including Copaxone, Glatopa.

Is Glatiramer approved by the US FDA?

Yes. The US FDA first approved Glatiramer on 20 December 1996, according to Drugs@FDA.

Does Glatiramer need cold chain shipping?

At least one listed presentation of Glatiramer must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

References

  1. Copaxone prescribing information (Teva Neuroscience). U.S. National Library of Medicine, DailyMed. Retrieved 23 June 2026

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