Glatiramer acetate

Drug Profile

Glatiramer acetate

Alternative Names: COP-1; Copaxone; Copolymer-1

Latest Information Update: 13 Dec 2016

Price : $50

At a glance

  • Originator Weizmann Institute of Science
  • Developer Lundbeck A/S; Proneuron Biotechnologies; Takeda; Teva Neuroscience; Teva Pharmaceutical Industries
  • Class Peptides; Polymers
  • Mechanism of Action Immunomodulators; MHC class II gene modulators
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Multiple sclerosis
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple sclerosis
  • Discontinued Amyotrophic lateral sclerosis; Glaucoma; Huntington's disease; Neurological disorders

Most Recent Events

  • 06 Dec 2016 Teva receives positive outcome to remove the pregnancy contraindication from glatiramer acetate label in Europe
  • 05 Sep 2016 Generic equivalent RemurelTM available in Europe for Multiple Sclerosis
  • 01 Sep 2016 The US Patent and Trademark Office found the US Patent No. 8 969 302 protecting 40 mg/mL glatiramer acetate, unpatentable, and rules in favor of Mylan in its inter partes review proceeding
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