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Last Updated: September 25, 2022

THIOLA Drug Patent 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. Two suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Thiola

A generic version of THIOLA was approved as tiopronin by TEVA PHARMS USA INC on April 26th, 2021.

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

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Recent Clinical Trials for THIOLA

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

SponsorPhase
Food and Drug Administration (FDA)Phase 2
University of WashingtonPhase 2
University of FloridaPhase 2

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Pharmacology for THIOLA
Anatomical Therapeutic Chemical (ATC) Classes for THIOLA

US Patents and Regulatory Information for THIOLA

THIOLA is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting THIOLA

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
Exclusivity Expiration: See Plans and Pricing

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 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mission Pharmacal Co THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843-001 Jun 28, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mission Pharmacal Co THIOLA EC tiopronin TABLET, DELAYED RELEASE;ORAL 211843-002 Jun 28, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Baxter
Dow
Harvard Business School
Boehringer Ingelheim

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