Tirosint is a drug owned by Institute Biochimique Sa (ibsa). It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2024. Details of Tirosint'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). | |||
| US7723390 | Pharmaceutical formulations for thyroid hormones |
Mar, 2024
(9 months ago) |
Expired
|
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's patents.
Latest Legal Activities on Tirosint's Patents
Given below is the list of recent legal activities going on the following patents of Tirosint.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Oct, 2021 | US7723390 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Sep, 2021 | US7691411 |
| Mail Certificate of Correction Memo | 23 Feb, 2021 | US7723390 |
| Certificate of Correction Memo | 18 Feb, 2021 | US7723390 |
| Post Issue Communication - Certificate of Correction | 18 Feb, 2021 | US7723390 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Oct, 2017 | US7723390 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Sep, 2017 | US7691411 |
| Patent Issue Date Used in PTA Calculation Critical | 25 May, 2010 | US7723390 |
| Recordation of Patent Grant Mailed Critical | 25 May, 2010 | US7723390 |
| Issue Notification Mailed Critical | 05 May, 2010 | US7723390 |
US patents provide insights into the exclusivity only within the United States, but Tirosint 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's family patents as well as insights into ongoing legal events on those patents.
Tirosint's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tirosint's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 14, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tirosint Generic API suppliers:
Levothyroxine Sodium is the generic name for the brand Tirosint. 16 different companies have already filed for the generic of Tirosint, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tirosint's generic
How can I launch a generic of Tirosint before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tirosint's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tirosint'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mcg and 150 mcg | 29 Dec, 2017 | 1 | 28 Oct, 2020 | 14 Mar, 2024 | Deferred |
| 88 mcg, 100 mcg and 125 mcg | 01 Aug, 2019 | 1 | 06 Jan, 2021 | 14 Mar, 2024 | Eligible |
| 112 mcg | 18 Dec, 2020 | 1 | 16 Apr, 2021 | 14 Mar, 2024 | Eligible |
| 200 mcg | 30 Dec, 2021 | 1 | 09 Nov, 2022 | 14 Mar, 2024 | Eligible |
| 137 mcg and 175 mcg | 04 Nov, 2022 | 1 | 02 May, 2023 | 14 Mar, 2024 | Eligible |
Alternative Brands for Tirosint
There are several other brand drugs using the same active ingredient (Levothyroxine Sodium) as Tirosint. 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 |
| |
| King Pharms |
| |
| Mylan |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levothyroxine Sodium, Tirosint's active ingredient. Check the complete list of approved generic manufacturers for Tirosint
About Tirosint
Tirosint is a drug owned by Institute Biochimique Sa (Ibsa). Tirosint uses Levothyroxine Sodium as an active ingredient. Tirosint was launched by Inst Biochimique in 2007.
Approval Date:
Tirosint was approved by FDA for market use on 01 August, 2007.
Active Ingredient:
Tirosint uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Dosage:
Tirosint is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.013MG | CAPSULE | Prescription | ORAL |
Tirosint is a drug owned by Ibsa Institut Biochimique Sa. It is protected by 2 US drug patents filed from 2016 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 14, 2024. Details of Tirosint'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). | |||
| US7723390 | Pharmaceutical formulations for thyroid hormones |
Mar, 2024
(9 months ago) |
Expired
|
| US7691411 | Pharmaceutical formulae for thyroid hormones and procedures for obtaining them |
Mar, 2024
(9 months ago) |
Expired
|
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's patents.
Latest Legal Activities on Tirosint's Patents
Given below is the list of recent legal activities going on the following patents of Tirosint.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Oct, 2021 | US7723390 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Sep, 2021 | US7691411 |
| Mail Certificate of Correction Memo | 23 Feb, 2021 | US7723390 |
| Certificate of Correction Memo | 18 Feb, 2021 | US7723390 |
| Post Issue Communication - Certificate of Correction | 18 Feb, 2021 | US7723390 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Oct, 2017 | US7723390 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Sep, 2017 | US7691411 |
| Patent Issue Date Used in PTA Calculation Critical | 25 May, 2010 | US7723390 |
| Recordation of Patent Grant Mailed Critical | 25 May, 2010 | US7723390 |
| Issue Notification Mailed Critical | 05 May, 2010 | US7723390 |
US patents provide insights into the exclusivity only within the United States, but Tirosint 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's family patents as well as insights into ongoing legal events on those patents.
Tirosint's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tirosint's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 14, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tirosint Generic API suppliers:
Levothyroxine Sodium is the generic name for the brand Tirosint. 16 different companies have already filed for the generic of Tirosint, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tirosint's generic
How can I launch a generic of Tirosint before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tirosint's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tirosint'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 75 mcg and 150 mcg | 29 Dec, 2017 | 1 | 28 Oct, 2020 | 14 Mar, 2024 | Deferred |
| 88 mcg, 100 mcg and 125 mcg | 01 Aug, 2019 | 1 | 06 Jan, 2021 | 14 Mar, 2024 | Eligible |
| 112 mcg | 18 Dec, 2020 | 1 | 16 Apr, 2021 | 14 Mar, 2024 | Eligible |
| 200 mcg | 30 Dec, 2021 | 1 | 09 Nov, 2022 | 14 Mar, 2024 | Eligible |
| 137 mcg and 175 mcg | 04 Nov, 2022 | 1 | 02 May, 2023 | 14 Mar, 2024 | Eligible |
Alternative Brands for Tirosint
There are several other brand drugs using the same active ingredient (Levothyroxine Sodium) as Tirosint. 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 |
| |
| King Pharms |
| |
| Mylan |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levothyroxine Sodium, Tirosint's active ingredient. Check the complete list of approved generic manufacturers for Tirosint
About Tirosint
Tirosint is a drug owned by Ibsa Institut Biochimique Sa. Tirosint uses Levothyroxine Sodium as an active ingredient. Tirosint was launched by Ibsa in 2007.
Approval Date:
Tirosint was approved by FDA for market use on 01 August, 2007.
Active Ingredient:
Tirosint uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Dosage:
Tirosint is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.125MG | CAPSULE | Prescription | ORAL |
| 0.112MG | CAPSULE | Prescription | ORAL |
| 0.088MG | CAPSULE | Prescription | ORAL |
| 0.2MG | CAPSULE | Prescription | ORAL |
| 0.15MG | CAPSULE | Prescription | ORAL |
| 0.025MG | CAPSULE | Prescription | ORAL |
| 0.137MG | CAPSULE | Prescription | ORAL |
| 0.175MG | CAPSULE | Prescription | ORAL |
| 0.05MG | CAPSULE | Prescription | ORAL |
| 0.013MG | CAPSULE | Prescription | ORAL |
| 0.1MG | CAPSULE | Prescription | ORAL |
| 0.075MG | CAPSULE | Prescription | ORAL |