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Copaxone

Copaxone

Synopsis, Chemistry

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17 API Suppliers, 5 USDMF, 3 EU WC, 7 NDC API, 13 Listed Suppliers

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11 Drug(s) in Development

11 Drug(s) in Development

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50 Dossiers, 7 FDA Orange Book, 31 Europe, 3 Canada, 4 Australia, 3 South Africa, 2 Listed Dossiers

DRUG PRODUCT COMPOSITION

FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL, INJECTABLE;SUBCUTANEOUS - 40MG/ML

FOR SOLUTION;SUBCUTANEOUS - 20MG/VIAL
INJECTABLE;SUBCUTANEOUS - 40MG/ML

RELATED EXCIPIENT COMPANIES

Suppliers, 12 SPI Pharma, 3 Roquette, 2 Gangwal Chemicals, 2 Kerry, 2 Microlex e.U, 2 Gangwal Healthcare, 1 Ingredion Pharma Solutions, 1 DKSH, 1 Pfanstiehl, 1 BASF, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Rochem International Inc, 1 Sigachi Industries, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

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18 Fillers, Diluents & Binders, 10 Direct Compression, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 4 Co-Processed Excipients, 3 Disintegrants & Superdisintegrants, 3 Parenteral, 3 Granulation, 1 API Stability Enhancers, 1 Thickeners and Stabilizers

GLOBAL SALES INFORMATION

22 US Medicaid Prescriptions, 6 Finished Drug Prices

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8 APIs, 4 DOSSIERS // FDF

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4 Health Canada Patents

4 Health Canada Patents

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API REF. PRICE (USD / KG)

181,695

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USA (Orange Book)

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

10,070.00

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2,366.00

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USFDA Orange Book Patents

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Blog #PharmaFlow

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210

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EDQM

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Also known as: 147245-92-9, Acetic acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2s)-2-aminopentanedioic acid;(2s)-2-aminopropanoic acid;(2s)-2,6-diaminohexanoic acid, Glatirameracetat, Dtxsid30163637, Am84438, Ac-28732

Molecular Formula

C₂₅H₄₅N₅O₁₃

Molecular Weight

623.7 g/mol

InChI Key

FHEAIOHRHQGZPC-KIWGSFCNSA-N

A random polymer of L-ALANINE, L-GLUTAMIC ACID, L-LYSINE, and L-TYROSINE that structurally resembles MYELIN BASIC PROTEIN. It is used in the treatment of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

1 2D Structure

Copaxone

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

acetic acid;(2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid;(2S)-2-aminopentanedioic acid;(2S)-2-aminopropanoic acid;(2S)-2,6-diaminohexanoic acid

2.1.2 InChI

InChI=1S/C9H11NO3.C6H14N2O2.C5H9NO4.C3H7NO2.C2H4O2/c10-8(9(12)13)5-6-1-3-7(11)4-2-6;7-4-2-1-3-5(8)6(9)10;6-3(5(9)10)1-2-4(7)8;1-2(4)3(5)6;1-2(3)4/h1-4,8,11H,5,10H2,(H,12,13);5H,1-4,7-8H2,(H,9,10);3H,1-2,6H2,(H,7,8)(H,9,10);2H,4H2,1H3,(H,5,6);1H3,(H,3,4)/t8-;5-;3-;2-;/m0000./s1

2.1.3 InChI Key

FHEAIOHRHQGZPC-KIWGSFCNSA-N

2.1.4 Canonical SMILES

CC(C(=O)O)N.CC(=O)O.C1=CC(=CC=C1CC(C(=O)O)N)O.C(CCN)CC(C(=O)O)N.C(CC(=O)O)C(C(=O)O)N

2.1.5 Isomeric SMILES

C[C@@H](C(=O)O)N.CC(=O)O.C1=CC(=CC=C1C[C@@H](C(=O)O)N)O.C(CCN)C[C@@H](C(=O)O)N.C(CC(=O)O)[C@@H](C(=O)O)N

2.2 Synonyms

2.2.1 MeSH Synonyms

1. 5010, Tv

2. Acetate, Glatiramer

3. Copaxone

4. Glatiramer

5. Tv 5010

6. Tv-5010

7. Tv5010

2.2.2 Depositor-Supplied Synonyms

1. 147245-92-9

2. Acetic Acid;(2s)-2-amino-3-(4-hydroxyphenyl)propanoic Acid;(2s)-2-aminopentanedioic Acid;(2s)-2-aminopropanoic Acid;(2s)-2,6-diaminohexanoic Acid

3. Glatirameracetat

4. Dtxsid30163637

5. Am84438

6. Ac-28732

7. L-alanine Compound With L-glutamic Acid And L-lysine And L-tyrosine And Acetic Acid (1:1:1:1:1)

8. Q418274

2.3 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₅H₄₅N₅O₁₃
Molecular Weight	623.7 g/mol
Hydrogen Bond Donor Count	12
Hydrogen Bond Acceptor Count	18
Rotatable Bond Count	13
Exact Mass	623.30138651 g/mol
Monoisotopic Mass	623.30138651 g/mol
Topological Polar Surface Area	374 Å²
Heavy Atom Count	43
Formal Charge	0
Complexity	519
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	5

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Copaxone
PubMed Health	Glatiramer (Injection)
Drug Classes	Central Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
Drug Label	Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0....
Active Ingredient	Glatiramer acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	20mg/ml; 40mg/ml
Market Status	Prescription
Company	Teva Pharms Usa

2 of 2
Drug Name	Copaxone
PubMed Health	Glatiramer (Injection)
Drug Classes	Central Nervous System Agent, Immune Suppressant, Musculoskeletal Agent
Drug Label	Glatiramer acetate, the active ingredient of COPAXONE, consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0....
Active Ingredient	Glatiramer acetate
Dosage Form	Injectable
Route	Subcutaneous
Strength	20mg/ml; 40mg/ml
Market Status	Prescription
Company	Teva Pharms Usa

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

Immunosuppressive Agents

Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

Adjuvants, Immunologic

Substances that augment, stimulate, activate, potentiate, or modulate the immune response at either the cellular or humoral level. The classical agents (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contain bacterial antigens. Some are endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Their mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy of many biological response modifiers is related to their antigen-specific immunoadjuvanticity. (See all compounds classified as Adjuvants, Immunologic.)

5.2 ATC Code

L03AX13

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

L - Antineoplastic and immunomodulating agents

L03 - Immunostimulants

L03A - Immunostimulants

L03AX - Other immunostimulants

L03AX13 - Glatiramer acetate