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Last Updated: June 21, 2021

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THIOLA Drug Profile


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Which patents cover Thiola, and when can generic versions of Thiola launch?

Thiola is a drug marketed by Mission Pharma and Mission Pharmacal Co and is included in two NDAs.

The generic ingredient in THIOLA is tiopronin. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tiopronin profile page.

Summary for THIOLA
Drug patent expirations by year for THIOLA
Drug Prices for THIOLA

See drug prices for THIOLA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for THIOLA
Generic Entry Date for THIOLA*:
Constraining patent/regulatory exclusivity:
INDICATED IN COMBINATION WITH HIGH FLUID INTAKE, ALKALI, AND DIET MODIFICATION, FOR THE PREVENTION OF CYSTINE STONE FORMATION IN PEDIATRIC PATIENTS 20KG TO 9 YEARS OF AGE W/SEVERE HOMOZYGOUS CYSTINURIA, WHO ARE NOT RESPONSIVE TO THESE MEASURES ALONE
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for THIOLA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of WashingtonPhase 2
E. Sander ConnollyPhase 2
University of FloridaPhase 2

See all THIOLA clinical trials

Pharmacology for THIOLA

US Patents and Regulatory Information for THIOLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mission Pharma THIOLA tiopronin TABLET;ORAL 019569-001 Aug 11, 1988 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Mission Pharmacal Co THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843-001 Jun 28, 2019 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Mission Pharmacal Co THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843-002 Jun 28, 2019 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Boehringer Ingelheim

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