Levaquin is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 2 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 Aug 26, 2022. Details of Levaquin'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). | |||
|
US6806256 (Pediatric) | Taste masked liquid pharmaceutical compositions |
Aug, 2022
(2 years ago) |
Expired
|
| US6806256 | Taste masked liquid pharmaceutical compositions |
Feb, 2022
(2 years 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 Levaquin's patents.
Latest Legal Activities on Levaquin's Patents
Given below is the list of recent legal activities going on the following patents of Levaquin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Issue Date Used in PTA Calculation Critical | 19 Oct, 2004 | US6806256 |
| Recordation of Patent Grant Mailed Critical | 19 Oct, 2004 | US6806256 |
| Issue Notification Mailed Critical | 30 Sep, 2004 | US6806256 |
| Receipt into Pubs | 22 Sep, 2004 | US6806256 |
| Dispatch to FDC | 21 Sep, 2004 | US6806256 |
| Application Is Considered Ready for Issue Critical | 21 Sep, 2004 | US6806256 |
| Issue Fee Payment Received Critical | 14 Sep, 2004 | US6806256 |
| Issue Fee Payment Verified Critical | 14 Sep, 2004 | US6806256 |
| Receipt into Pubs | 10 Aug, 2004 | US6806256 |
| Workflow - File Sent to Contractor | 28 Jun, 2004 | US6806256 |
US patents provide insights into the exclusivity only within the United States, but Levaquin 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 Levaquin's family patents as well as insights into ongoing legal events on those patents.
Levaquin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Levaquin's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 26, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Levaquin Generic API suppliers:
Levofloxacin is the generic name for the brand Levaquin. 36 different companies have already filed for the generic of Levaquin, with Gland Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Levaquin's generic
How can I launch a generic of Levaquin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Levaquin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Levaquin'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 Levaquin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/mL; 50 mL, 100 mL and 150 mL vials | |||||
| 25 mg/mL | |||||
| 25 mg/mL | 30 Jul, 2009 | 1 | 20 Jun, 2011 | 26 Feb, 2022 | Eligible |
| 250 mg, 500 mg and 750 mg |
About Levaquin
Levaquin is a drug owned by Janssen Pharmaceuticals Inc. Levaquin uses Levofloxacin as an active ingredient. Levaquin was launched by Janssen Pharms in 2004.
Approval Date:
Levaquin was approved by FDA for market use on 21 October, 2004.
Active Ingredient:
Levaquin uses Levofloxacin as the active ingredient. Check out other Drugs and Companies using Levofloxacin ingredient
Dosage:
Levaquin is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 250MG/10ML | SOLUTION | Discontinued | ORAL |