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Tiopronin Patent Expiration

Tiopronin is Used for preventing cystine stone formation in individuals with severe homozygous cystinuria. It was first introduced by Mission Pharmacal Co in its drug Thiola on Aug 11, 1988. Another drug containing Tiopronin is Thiola Ec. 6 different companies have introduced drugs containing Tiopronin.


Tiopronin Patents

Given below is the list of patents protecting Tiopronin, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Thiola Ec US11458104 Enteric coated tiopronin tablet Nov 14, 2038 Mission Pharmacal


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tiopronin's patents.

Given below is the list recent legal activities going on the following patents of Tiopronin.

Event Date Patent/Publication
Patent litigations
Recordation of Patent Grant Mailed 04 Oct, 2022 US11458104
Application ready for PDX access by participating foreign offices 04 Oct, 2022 US11458104
Patent Issue Date Used in PTA Calculation 04 Oct, 2022 US11458104
Email Notification 15 Sep, 2022 US11458104
Issue Notification Mailed 14 Sep, 2022 US11458104
Dispatch to FDC 12 Sep, 2022 US11458104
Application Is Considered Ready for Issue 12 Sep, 2022 US11458104
Email Notification 05 Aug, 2022 US11458104
Mailing Corrected Notice of Allowability 05 Aug, 2022 US11458104
Corrected Notice of Allowability 01 Aug, 2022 US11458104



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Tiopronin Generics

Several generic applications have been filed for Tiopronin. The first generic version for Tiopronin was by Teva Pharmaceuticals Usa Inc and was approved on Apr 26, 2021. And the latest generic version is by Torrent Pharmaceuticals Ltd and was approved on Jan 30, 2024.

Given below is the list of companies who have filed for Tiopronin generic.


1. TORRENT

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Tiopronin. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG tablet, delayed release Prescription ORAL AB Jan 30, 2024
100MG tablet, delayed release Prescription ORAL AB Jan 30, 2024


2. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Tiopronin. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet Prescription ORAL AB Apr 26, 2021


3. AMNEAL

Amneal Eu Ltd has filed for 1 generic for Tiopronin. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG tablet, delayed release Prescription ORAL AB Aug 15, 2023


4. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Tiopronin. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG tablet, delayed release Prescription ORAL AB Feb 24, 2023
300MG tablet, delayed release Prescription ORAL AB Feb 24, 2023