Levoxyl is a drug owned by King Pharmaceuticals Research And Development Llc. It is protected by 3 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 02, 2023. Details of Levoxyl'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). | |||
| US6555581 | Levothyroxine compositions and methods |
Feb, 2022
(2 years ago) |
Expired
|
| US7067148 | Stabilized pharmaceutical and thyroid hormone compositions and method of preparation |
Feb, 2022
(2 years ago) |
Expired
|
| US7101569 | Methods of administering levothyroxine pharmaceutical compositions |
Oct, 2023
(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 Levoxyl's patents.
Latest Legal Activities on Levoxyl's Patents
Given below is the list of recent legal activities going on the following patents of Levoxyl.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Feb, 2018 | US7101569 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Nov, 2017 | US7067148 |
| File Marked Found | 21 Sep, 2017 | US6555581 |
| Change in Power of Attorney (May Include Associate POA) | 16 Aug, 2016 | US6555581 |
| Email Notification | 16 Aug, 2016 | US6555581 |
| Correspondence Address Change | 15 Aug, 2016 | US6555581 |
| File Marked Found | 05 Feb, 2016 | US6555581 |
| File Marked Found | 28 Jan, 2016 | US6555581 |
| Correspondence Address Change | 02 Sep, 2014 | US6555581 |
| Correspondence Address Change | 02 Sep, 2014 | US7067148 |
US patents provide insights into the exclusivity only within the United States, but Levoxyl 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 Levoxyl's family patents as well as insights into ongoing legal events on those patents.
Levoxyl's family patents
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Generic Launch
Generic Release Date:
Levoxyl's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 02, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levoxyl Generics:
Levothyroxine Sodium is the generic name for the brand Levoxyl. 14 different companies have already filed for the generic of Levoxyl, with Mylan having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Levoxyl's generic
How can I launch a generic of Levoxyl before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Levoxyl's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Levoxyl'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 Levoxyl -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg |
About Levoxyl
Levoxyl is a drug owned by King Pharmaceuticals Research And Development Llc. It is used for treating hypothyroidism and preventing goiter. Levoxyl uses Levothyroxine Sodium as an active ingredient. Levoxyl was launched by King Pharms in 2001.
Market Authorisation Date:
Levoxyl was approved by FDA for market use on 25 May, 2001.
Active Ingredient:
Levoxyl uses Levothyroxine Sodium as the active ingredient. Check out other Drugs and Companies using Levothyroxine Sodium ingredient
Treatment:
Levoxyl is used for treating hypothyroidism and preventing goiter.
Dosage:
Levoxyl is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |
| 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium | TABLET | Prescription | ORAL |