• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
Generic Name: glatiramer acetate
Trade Name: Copaxone
Date Designated: 11/09/1987
Orphan Designation: Treatment of multiple sclerosis
Orphan Designation Status: Designated/Approved
Teva Pharmaceuticals USA
1510 Delp Drive
Kulpsville, Pennsylvania 19443
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: glatiramer acetate
Trade Name: Copaxone
Marketing Approval Date: 12/20/1996
Approved Labeled Indication: For reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis.
Exclusivity End Date: 12/20/2003 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-