Levothyroxine Sodium is a drug owned by Fresenius Kabi Usa Llc. It is protected by 6 US drug patents filed from 2015 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 01, 2036. Details of Levothyroxine Sodium'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9168238 | Levothyroxine formulations |
Aug, 2032
(8 years from now) | Active |
| US9168239 | Levothyroxine formulations |
Aug, 2032
(8 years from now) | Active |
| US9006289 | Levothyroxine formulations |
Oct, 2032
(8 years from now) | Active |
| US11135190 | Levothyroxine liquid formulations |
Dec, 2036
(12 years from now) | Active |
| US9782376 | Levothyroxine liquid formulations |
Dec, 2036
(12 years from now) | Active |
| US10398669 | Levothyroxine liquid formulations |
Dec, 2036
(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 Levothyroxine Sodium's patents.
Latest Legal Activities on Levothyroxine Sodium's Patents
Given below is the list of recent legal activities going on the following patents of Levothyroxine Sodium.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2023 | US10537538 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2023 | US9168238 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2023 | US9168239 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Mar, 2023 | US10398669 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 Dec, 2022 | US9050307 |
| Change in Power of Attorney (May Include Associate POA) | 01 Dec, 2022 | US9168238 |
| Email Notification | 01 Dec, 2022 | US9168239 |
| Change in Power of Attorney (May Include Associate POA) | 01 Dec, 2022 | US9168239 |
| Email Notification | 01 Dec, 2022 | US9168238 |
| Correspondence Address Change | 21 Nov, 2022 | US9168238 |
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 Levothyroxine Sodium and ongoing litigations to help you estimate the early arrival of Levothyroxine Sodium generic.
Levothyroxine Sodium's Litigations
Levothyroxine Sodium has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jan 19, 2017, against patent number US9168239. The petitioner Mylan Institutional Inc., challenged the validity or infringement of this patent, with Fresenius Kabi USA LLC as the respondent. Click below to track the latest information on how companies are challenging Levothyroxine Sodium's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9006289 | January, 2017 | Terminated-Settled | Fresenius Kabi USA, LLC | Mylan Institutional Inc. |
| US9168238 | January, 2017 | Terminated-Settled | Fresenius Kabi USA, LLC | Mylan Institutional Inc. |
| US9168239 | January, 2017 | Terminated-Settled | Fresenius Kabi USA LLC | Mylan Institutional Inc. |
US patents provide insights into the exclusivity only within the United States, but Levothyroxine Sodium 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 Levothyroxine Sodium's family patents as well as insights into ongoing legal events on those patents.
Levothyroxine Sodium's family patents
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Generic Launch
Generic Release Date:
Levothyroxine Sodium's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levothyroxine Sodium Generics:
Levothyroxine Sodium is the generic name for the brand Levothyroxine Sodium. 14 different companies have already filed for the generic of Levothyroxine Sodium, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Levothyroxine Sodium's generic
How can I launch a generic of Levothyroxine Sodium before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Levothyroxine Sodium's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Levothyroxine Sodium'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 Levothyroxine Sodium -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mcg/vial and 500 mcg/vial | 14 Apr, 2015 | 2 | 29 Jun, 2016 | 03 Oct, 2032 | Eligible |
| 200 mcg/vial | 01 May, 2015 | 1 | 07 Dec, 2015 | 03 Oct, 2032 | Deferred |
About Levothyroxine Sodium
Levothyroxine Sodium is a drug owned by Fresenius Kabi Usa Llc. Levothyroxine Sodium uses Levothyroxine Sodium as an active ingredient. Levothyroxine Sodium was launched by Fresenius Kabi Usa in 2011.
Market Authorisation Date:
Levothyroxine Sodium was approved by FDA for market use on 24 June, 2011.
Active Ingredient:
Levothyroxine Sodium uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Dosage:
Levothyroxine Sodium is available in the following dosage forms - solution form for intravenous use, powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MCG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 100MCG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 500MCG/VIAL | POWDER | Prescription | INTRAVENOUS |
| 100MCG/5ML (20MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 200MCG/5ML (40MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 500MCG/5ML (100MCG/ML) | SOLUTION | Prescription | INTRAVENOUS |
Levothyroxine Sodium is a drug owned by Hikma Pharmaceuticals Usa Inc. It is protected by 1 US drug patent filed in 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 20, 2036. Details of Levothyroxine Sodium'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11154498 | Stabilized liquid formulation of levothyroxine |
Jul, 2036
(11 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 Levothyroxine Sodium's patents.
Latest Legal Activities on Levothyroxine Sodium's Patents
Given below is the list of recent legal activities going on the following patents of Levothyroxine Sodium.
| Event | Date | Patent/Publication |
|---|---|---|
| | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2023 | US10537538 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2023 | US9168238 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 27 Apr, 2023 | US9168239 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Mar, 2023 | US10398669 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 07 Dec, 2022 | US9050307 |
| Change in Power of Attorney (May Include Associate POA) | 01 Dec, 2022 | US9168238 |
| Email Notification | 01 Dec, 2022 | US9168239 |
| Change in Power of Attorney (May Include Associate POA) | 01 Dec, 2022 | US9168239 |
| Email Notification | 01 Dec, 2022 | US9168238 |
| Correspondence Address Change | 21 Nov, 2022 | US9168238 |
US patents provide insights into the exclusivity only within the United States, but Levothyroxine Sodium 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 Levothyroxine Sodium's family patents as well as insights into ongoing legal events on those patents.
Levothyroxine Sodium's family patents
Coming Soon
Patent Strength Analyzer
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Thank you for your response 🥳
Generic Launch
Generic Release Date:
Levothyroxine Sodium's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 20, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levothyroxine Sodium Generics:
Levothyroxine Sodium is the generic name for the brand Levothyroxine Sodium. 14 different companies have already filed for the generic of Levothyroxine Sodium, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Levothyroxine Sodium's generic
How can I launch a generic of Levothyroxine Sodium before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Levothyroxine Sodium's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Levothyroxine Sodium'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 Levothyroxine Sodium -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mcg/vial and 500 mcg/vial | 14 Apr, 2015 | 2 | 29 Jun, 2016 | 03 Oct, 2032 | Eligible |
| 200 mcg/vial | 01 May, 2015 | 1 | 07 Dec, 2015 | 03 Oct, 2032 | Deferred |
About Levothyroxine Sodium
Levothyroxine Sodium is a drug owned by Hikma Pharmaceuticals Usa Inc. Levothyroxine Sodium uses Levothyroxine Sodium as an active ingredient. Levothyroxine Sodium was launched by Hikma in 2021.
Market Authorisation Date:
Levothyroxine Sodium was approved by FDA for market use on 17 May, 2021.
Active Ingredient:
Levothyroxine Sodium uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Dosage:
Levothyroxine Sodium is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MCG/ML | SOLUTION | Prescription | INTRAVENOUS |