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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Tiopronin
Trade Name: Thiola
Date Designated: 01/17/1986
Orphan Designation: Prevention of cystine nephrolithiasis in patients with homozygous cystinuria.
Orphan Designation Status: Designated/Approved
Mission Pharmacal Company
P.O. Box 786099
San Antonio, Texas 78278
United States

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

Marketing approved:

1 Generic Name: Tiopronin
Trade Name: Thiola
Marketing Approval Date: 08/11/1988
Approved Labeled Indication: Indicated for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria with urinary cystine greater than 500 mg/day, who are resistant to treatment with conservative measures of high fluid intake, alkali and diet modification or who have adverse reactions to d-penicillamine.
Exclusivity End Date: 08/11/1995 
Exclusivity Protected Indication* :  
2 Generic Name: Tiopronin
Trade Name: Thiola
Marketing Approval Date: 06/28/2019
Approved Labeled Indication: THIOLA EC is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.
Exclusivity End Date: 06/28/2026 
Exclusivity Protected Indication* :  
3 Generic Name: Tiopronin
Trade Name: Thiola
Marketing Approval Date: 06/28/2019
Approved Labeled Indication: THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.
Exclusivity End Date: 06/28/2026 
Exclusivity Protected Indication* :  Indicated in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in pediatric patients between 20 kg and 9 years of age with severe homozygous cystinuria, who are not responsive to these measures alone
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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