Is glatiramer acetate a generic drug?

The FDA has approved three generic forms of glatiramer acetate, and the agency has received Abbreviated New Drug Applications for other generic forms of this medication. With the exception of Novantrone and Copaxone, no other disease-modifying MS medications are available in a generic form.

What is the brand name for glatiramer acetate?

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.

Does Copaxone come in generic?

The U.S. Food and Drug Administration has approved a second generic form of 40mg glatiramer acetate injection, called Glatopa® (Sandoz). This is a generic form of 40mg Copaxone® (Teva Pharmaceutical Industries LTD), taken three days per week by injections under the skin to treat relapsing forms of MS.

Is glatiramer acetate the same as Copaxone?

A generic equivalent of daily Copaxone® (glatiramer acetate, 20 mg), called “Glatopa”™ (Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals) that was approved by the U.S. Food and Drug Administration in April, has been launched in the U.S. Glatopa is a disease-modifying therapy for …

Is the glatiramer acetate 20 mg / mL approved in Europe?

Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe. Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone®* for the treatment of relapsing remitting multiple sclerosis (RRMS).

How is Synthon a vertically integrated pharmaceutical company?

Synthon’s strategy from its inception included the development of a vertically integrated organization for small-molecule generics, controlling every facet of the development chain beginning with research, development and production of active pharmaceutical ingredients through to manufacture and sale of our drug products.

What is synthon and what is its mission?

Synthon – Providing affordable, high-quality small-molecule generics and hybrids. Our mission is to make healthcare more affordable and to improve access to important medicines through the provision of high-quality small-molecule generics and hybrids to patients all around the world.