COPAXONE® is the brand name for glatiramer acetate (formerly
known as copolymer-1). 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 0.141, 0.427, 0.095, and
0.338, respectively. The average molecular weight of glatiramer acetate
is 4,700-11,000 daltons.
Chemically, glatiramer acetate is designated L-glutamic acid polymer
with L-alanine, L-lysine and L-tyrosine, acetate(salt). Its structural
(Glu, Ala, Lys, Tyr) x.X CH3COOH
COPAXONE ® is a white to off-white, sterile, lyophilized
powder containing 20mg of glatiramer acetate and 40mg of manrntol. It
is supplied in single-usevials for subcutaneous administration after reconstitution
with the diluent supplied (Sterile Water for Injection).