Tirosint-sol is a drug owned by Ibsa Institut Biochimique Sa. It is protected by 3 US drug patents filed from 2020 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2039. Details of Tirosint-sol'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). | |||
| US11241382 | Administration regimen of compositions of T4 thyroid hormone with high oral absorption |
Sep, 2039
(14 years from now) | Active |
| US11096913 | High-stability packaged solutions of T4 thyroid hormone |
Feb, 2037
(12 years from now) | Active |
| US10537538 | High-stability packaged solutions of T4 thyroid hormone |
Feb, 2037
(12 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 Tirosint-sol's patents.
Latest Legal Activities on Tirosint-sol's Patents
Given below is the list of recent legal activities going on the following patents of Tirosint-sol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2023 | US10537538 |
| Recordation of Patent Grant Mailed Critical | 08 Feb, 2022 | US11241382 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Feb, 2022 | US11241382 |
| Email Notification Critical | 21 Jan, 2022 | US11241382 |
| Issue Notification Mailed Critical | 19 Jan, 2022 | US11241382 |
| Dispatch to FDC | 07 Jan, 2022 | US11241382 |
| Application Is Considered Ready for Issue Critical | 07 Jan, 2022 | US11241382 |
| Issue Fee Payment Received Critical | 23 Dec, 2021 | US11241382 |
| Issue Fee Payment Verified Critical | 23 Dec, 2021 | US11241382 |
| Mail Notice of Allowance Critical | 05 Nov, 2021 | US11241382 |
Several oppositions have been filed on Tirosint-sol's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tirosint-sol's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tirosint-sol patents.
Tirosint-sol's Oppositions Filed in EPO
Tirosint-sol has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Apr 21, 2021, by Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.. This opposition was filed on patent number EP17794903A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17794903A | Apr, 2021 | Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Tirosint-sol 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 Tirosint-sol's family patents as well as insights into ongoing legal events on those patents.
Tirosint-sol's Family Patents
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Generic Launch
Generic Release Date:
Tirosint-sol's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 17, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tirosint-sol Generic API suppliers:
Levothyroxine Sodium is the generic name for the brand Tirosint-sol. 16 different companies have already filed for the generic of Tirosint-sol, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tirosint-sol's generic
How can I launch a generic of Tirosint-sol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tirosint-sol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tirosint-sol'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 Tirosint-sol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL | 30 Sep, 2022 | 1 | 28 Feb, 2037 |
Alternative Brands for Tirosint-sol
Tirosint-sol which is used for treating hypothyroidism and suppressing pituitary thyrotropin levels., has several other brand drugs using the same active ingredient (Levothyroxine Sodium). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Azurity |
| |
| Cediprof Inc |
| |
| Fresenius Kabi Usa |
| |
| Genus Lifesciences |
| |
| Hikma |
| |
| Ibsa |
| |
| Inst Biochimique |
| |
| King Pharms |
| |
| Mylan |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levothyroxine Sodium, Tirosint-sol's active ingredient. Check the complete list of approved generic manufacturers for Tirosint-sol
About Tirosint-sol
Tirosint-Sol is a drug owned by Ibsa Institut Biochimique Sa. It is used for treating hypothyroidism and suppressing pituitary thyrotropin levels. Tirosint-Sol uses Levothyroxine Sodium as an active ingredient. Tirosint-Sol was launched by Ibsa in 2016.
Approval Date:
Tirosint-sol was approved by FDA for market use on 15 December, 2016.
Active Ingredient:
Tirosint-sol uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Treatment:
Tirosint-sol is used for treating hypothyroidism and suppressing pituitary thyrotropin levels.
Dosage:
Tirosint-sol is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 13MCG/ML | SOLUTION | Prescription | ORAL |
| 62.5MCG/ML | SOLUTION | Prescription | ORAL |
| 44MCG/ML | SOLUTION | Prescription | ORAL |
| 37.5MCG/ML | SOLUTION | Prescription | ORAL |
| 200MCG/ML | SOLUTION | Prescription | ORAL |
| 175MCG/ML | SOLUTION | Prescription | ORAL |
| 150MCG/ML | SOLUTION | Prescription | ORAL |
| 137MCG/ML | SOLUTION | Prescription | ORAL |
| 125MCG/ML | SOLUTION | Prescription | ORAL |
| 112MCG/ML | SOLUTION | Prescription | ORAL |
| 100MCG/ML | SOLUTION | Prescription | ORAL |
| 88MCG/ML | SOLUTION | Prescription | ORAL |
| 75MCG/ML | SOLUTION | Prescription | ORAL |
| 50MCG/ML | SOLUTION | Prescription | ORAL |
| 25MCG/ML | SOLUTION | Prescription | ORAL |