Thiola Ec is a drug owned by Mission Pharmacal Co. It is protected by 1 US drug patent filed in 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 14, 2038. Details of Thiola Ec's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11458104 | Enteric coated tiopronin tablet |
Nov, 2038
(13 years from now) | Active |
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 Thiola Ec's patents.
Latest Legal Activities on Thiola Ec's Patents
Given below is the list of recent legal activities going on the following patents of Thiola Ec.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 04 Oct, 2022 | US11458104 |
| Application ready for PDX access by participating foreign offices Critical | 04 Oct, 2022 | US11458104 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Oct, 2022 | US11458104 |
| Email Notification Critical | 15 Sep, 2022 | US11458104 |
| Issue Notification Mailed Critical | 14 Sep, 2022 | US11458104 |
| Dispatch to FDC | 12 Sep, 2022 | US11458104 |
| Application Is Considered Ready for Issue Critical | 12 Sep, 2022 | US11458104 |
| Email Notification Critical | 05 Aug, 2022 | US11458104 |
| Mailing Corrected Notice of Allowability | 05 Aug, 2022 | US11458104 |
| Corrected Notice of Allowability | 01 Aug, 2022 | US11458104 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Thiola Ec and ongoing litigations to help you estimate the early arrival of Thiola Ec generic.
Thiola Ec's Litigations
Thiola Ec been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Oct 25, 2021, against patent number US11458104. The petitioner , challenged the validity of this patent, with Mission Pharmacal Company as the respondent. Click below to track the latest information on how companies are challenging Thiola Ec's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US11458104 | October, 2021 |
Decision
(15 Mar, 2022) | Mission Pharmacal Company | |
FDA has granted some exclusivities to Thiola Ec. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Thiola Ec, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Thiola Ec.
Exclusivity Information
Thiola Ec holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Thiola Ec's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| ODE*(ODE*) | Jun 28, 2026 |
US patents provide insights into the exclusivity only within the United States, but Thiola Ec is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Thiola Ec's family patents as well as insights into ongoing legal events on those patents.
Thiola Ec's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Thiola Ec's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 14, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Thiola Ec Generic API suppliers:
Tiopronin is the generic name for the brand Thiola Ec. 5 different companies have already filed for the generic of Thiola Ec, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Thiola Ec's generic
How can I launch a generic of Thiola Ec before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Thiola Ec's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Thiola Ec's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Thiola Ec -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg and 300 mg | 11 Oct, 2022 | 2 | 24 Feb, 2023 | 14 Nov, 2038 | Eligible |
About Thiola Ec
Thiola Ec is a drug owned by Mission Pharmacal Co. It is used for preventing cystine stone formation in individuals with severe homozygous cystinuria. Thiola Ec uses Tiopronin as an active ingredient. Thiola Ec was launched by Mission Pharmacal in 2019.
Approval Date:
Thiola Ec was approved by FDA for market use on 28 June, 2019.
Active Ingredient:
Thiola Ec uses Tiopronin as the active ingredient. Check out other Drugs and Companies using Tiopronin ingredient
Treatment:
Thiola Ec is used for preventing cystine stone formation in individuals with severe homozygous cystinuria.
Dosage:
Thiola Ec is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET, DELAYED RELEASE | Prescription | ORAL |
| 300MG | TABLET, DELAYED RELEASE | Prescription | ORAL |