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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: everolimus
Trade Name: Afinitor
Date Designated: 06/08/2009
Orphan Designation: Treatment of tuberous sclerosis complex including TSC-associated subependymal giant cell astrocytoma (SEGA), TSC-associated angiomyolipoma and TSC-associated lymphangioleiomyomatosis (LAM)
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: 10/29/2010
Approved Labeled Indication: Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection
Exclusivity End Date: 10/29/2017 
Exclusivity Protected Indication* :  
2 Generic Name: everolimus
Trade Name: Afinitor
Marketing Approval Date: 04/26/2012
Approved Labeled Indication: Treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC) not requiring immediate surgery.
Exclusivity End Date: 04/26/2019 
Exclusivity Protected Indication* :  
3 Generic Name: everolimus
Trade Name: Afinitor
Marketing Approval Date: 04/10/2018
Approved Labeled Indication: For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
Exclusivity End Date: 04/10/2025 
Exclusivity Protected Indication* :  For the adjunctive treatment of adult and pediatric patients age 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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