Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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: romiplostim
Trade Name: Nplate
Date Designated: 03/27/2003
Orphan Designation: Treatment of immune thrombocytopenic purpura
Orphan Designation Status: Designated/Approved
Amgen, Inc.
One Amgen Center Drive
Mail Stop: 27-2-D
Thousand Oaks, California 91320
United States

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

Marketing approved:

1 Generic Name: romiplostim
Trade Name: Nplate
Marketing Approval Date: 08/22/2008
Approved Labeled Indication: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Exclusivity End Date: 08/22/2015 
Exclusivity Protected Indication* :  
2 Generic Name: romiplostim
Trade Name: Nplate
Marketing Approval Date: 12/14/2018
Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity End Date: 12/14/2025 
Exclusivity Protected Indication* :  Nplate is indicated for the treatment of pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
3 Generic Name: romiplostim
Trade Name: Nplate
Marketing Approval Date: 10/17/2019
Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Exclusivity End Date: 10/17/2026 
Exclusivity Protected Indication* :  For the treatment of thrombocytopenia in adult patients with non-chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-