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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: levodopa and carbidopa
Trade Name: Duopa
Date Designated: 01/18/2000
Orphan Designation: Treatment of late stage Parkinson's disease
Orphan Designation Status: Designated/Approved
AbbVie, Inc.
1 N. Waukegan Road
Building AP30-1
North Chicago, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: levodopa and carbidopa
Trade Name: Duopa
Marketing Approval Date: 01/09/2015
Approved Labeled Indication: Treatment of motor flucuations in patients with advanced Parkinson's disease
Exclusivity End Date: 01/09/2022 
Exclusivity Protected Indication* :  Treatment of motor flucuations in patients with advanced Parkinson's disease
2 Generic Name: foscarbidopa and foslevodopa
Trade Name: Vyalev
Marketing Approval Date: 10/16/2024
Approved Labeled Indication: treatment of motor fluctuations in adults with advanced Parkinson's disease (PD)
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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