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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: budesonide
Trade Name: Tarpeyo
Date Designated: 05/17/2010
Orphan Designation: To slow the progression of immunoglobulin A nephropathy & delay kidney failure in patients affected by the disease.
Orphan Designation Status: Designated/Approved
Calliditas Therapeutics AB
Kungsbron 1
Stockholm SE-111 22
Sweden

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

Marketing approved:

1 Generic Name: budesonide
Trade Name: Tarpeyo
Marketing Approval Date: 12/15/2021
Approved Labeled Indication: to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) > or = 1.5 g/g
Exclusivity End Date: 12/15/2028 
Exclusivity Protected Indication* :  to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) > or = 1.5 g/g
2 Generic Name: budesonide
Trade Name: Tarpeyo
Marketing Approval Date: 12/20/2023
Approved Labeled Indication: to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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