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Drug ReportsGlatiramer acetate
Glatiramer acetate
Copaxone, Glatiramer, Glatopa (glatiramer acetate) is a small molecule pharmaceutical. Glatiramer acetate was first approved as Copaxone on 1996-12-20. It is used to treat relapsing-remitting multiple sclerosis in the USA.
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Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
immune system diseasesD007154
Trade Name
FDA
EMA
Copaxone, Glatiramer, Glatopa (discontinued: Copaxone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glatiramer acetate
Tradename
Company
Number
Date
Products
COPAXONETevaN-020622 RX2002-02-12
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
copaxoneNew Drug Application2023-11-30
glatiramer acetateANDA2024-01-15
glatopaANDA2024-01-11
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L03: Immunostimulants
— L03A: Immunostimulants
— L03AX: Other immunostimulants in atc
— L03AX13: Glatiramer acetate
HCPCS
Code
Description
J1595
Injection, glatiramer acetate, 20 mg
Clinical
No data
Drug
General
Drug common nameGlatiramer acetate
INN—
Description
Glatiramer acetate (also known as Copolymer 1, Cop-1), sold under the brand name Copaxone among others, is an immunomodulator medication used to treat multiple sclerosis. Glatiramer acetate is approved in the United States to reduce the frequency of relapses, but not for reducing the progression of disability. Observational studies, but not randomized controlled trials, suggest that it may reduce progression of disability. While a conclusive diagnosis of multiple sclerosis requires a history of two or more episodes of symptoms and signs, glatiramer acetate is approved to treat a first episode anticipating a diagnosis. It is also used to treat relapsing-remitting multiple sclerosis. It is administered by subcutaneous injection.
Classification
Small molecule
Drug classpolymers
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID147245-92-9
RxCUI—
ChEMBL IDCHEMBL1201507
ChEBI ID—
PubChem CID3081884
DrugBankDB05259
UNII ID—
Target
No data
Variants
No data
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â‚£
Copaxone – Teva
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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