Levothyroxine Sodium Patent Expiration

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


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
Patent litigations
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.

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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

Levothyroxine Sodium has patent protection in a total of 3 countries. It has a significant patent presence in the US with 85.7% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Levothyroxine Sodium.

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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 - powder form for intravenous use, solution 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
500MCG/5ML (100MCG/ML) SOLUTION Prescription INTRAVENOUS
200MCG/5ML (40MCG/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

(12 years from now)

Active

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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

Levothyroxine Sodium has patent protection in a total of 3 countries. It has a significant patent presence in the US with 60.0% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Levothyroxine Sodium.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

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