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: everolimus
Trade Name: Afinitor
Date Designated: 02/14/2008
Orphan Designation: Treatment of neuroendocrine tumors
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
One Health Plaza, 315/5450A
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: everolimus
Trade Name: Afinitor
Marketing Approval Date: 05/05/2011
Approved Labeled Indication: Treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.
Exclusivity End Date: 05/05/2018 
Exclusivity Protected Indication* :  
2 Generic Name: everolimus
Trade Name: Afinitor
Marketing Approval Date: 02/26/2016
Approved Labeled Indication: Treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease; and treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, with unresectable, locally advanced or metastatic disease.
Exclusivity End Date: 02/26/2023 
Exclusivity Protected Indication* :  Treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) (excluding pancreatic) or lung origin, with unresectable, locally advanced or metastatic disease.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-