Zyvox is a drug owned by Pfizer Inc. It is protected by 6 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2021. Details of Zyvox's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6559305 | Linezolid—crystal form II |
Jan, 2021
(3 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US6514529 (Pediatric) | Oxazolidinone tablet formulation |
Sep, 2021
(3 years ago) |
Expired
|
|
US6559305 (Pediatric) | Linezolid—crystal form II |
Jul, 2021
(3 years ago) |
Expired
|
| US6514529 | Oxazolidinone tablet formulation |
Mar, 2021
(3 years ago) |
Expired
|
| US6559305 | Linezolid—crystal form II |
Jan, 2021
(3 years ago) |
Expired
|
|
US5688792 (Pediatric) | Substituted oxazine and thiazine oxazolidinone antimicrobials |
May, 2015
(9 years ago) |
Expired
|
| US5688792 | Substituted oxazine and thiazine oxazolidinone antimicrobials |
Nov, 2014
(10 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 Zyvox's patents.
Latest Legal Activities on Zyvox's Patents
Given below is the list of recent legal activities going on the following patents of Zyvox.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Correspondence Address Change Critical | 29 Aug, 2014 | US6559305 (Litigated) |
| Correspondence Address Change Critical | 28 Aug, 2014 | US6514529 |
| Patent Issue Date Used in PTA Calculation Critical | 06 May, 2003 | US6559305 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 06 May, 2003 | US6559305 (Litigated) |
| Issue Notification Mailed Critical | 17 Apr, 2003 | US6559305 (Litigated) |
| Receipt into Pubs | 07 Apr, 2003 | US6559305 (Litigated) |
| Application Is Considered Ready for Issue Critical | 03 Apr, 2003 | US6559305 (Litigated) |
| Receipt into Pubs | 02 Apr, 2003 | US6559305 (Litigated) |
| Receipt into Pubs | 03 Mar, 2003 | US6559305 (Litigated) |
| Workflow - File Sent to Contractor | 03 Mar, 2003 | US6559305 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Zyvox 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 Zyvox's family patents as well as insights into ongoing legal events on those patents.
Zyvox's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zyvox's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 15, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zyvox Generic API suppliers:
Linezolid is the generic name for the brand Zyvox. 23 different companies have already filed for the generic of Zyvox, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zyvox's generic
How can I launch a generic of Zyvox before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zyvox's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyvox'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 Zyvox -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 2 mg/mL, 100 mL bag | 29 Dec, 2009 | 1 | 16 Jul, 2015 | 18 Nov, 2014 | Extinguished |
| 2 mg/mL, 300 mL bag | 01 Sep, 2009 | 1 | 27 Jun, 2012 | 18 Nov, 2014 | Deferred |
| 100 mg/5 mL | 03 Aug, 2009 | 1 | 03 Jun, 2015 | 29 Jan, 2021 | Deferred |
| 600 mg | 21 Dec, 2005 | 1 | 18 May, 2015 | 18 Nov, 2014 | Eligible |
About Zyvox
Zyvox is a drug owned by Pfizer Inc. It is used for treating microbial infections. Zyvox uses Linezolid as an active ingredient. Zyvox was launched by Pfizer in 2000.
Approval Date:
Zyvox was approved by FDA for market use on 18 April, 2000.
Active Ingredient:
Zyvox uses Linezolid as the active ingredient. Check out other Drugs and Companies using Linezolid ingredient
Treatment:
Zyvox is used for treating microbial infections.
Dosage:
Zyvox is available in the following dosage forms - for suspension form for oral use, tablet form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600MG | TABLET | Prescription | ORAL |
| 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 600MG/300ML (2MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 200MG/100ML (2MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 100MG/5ML | FOR SUSPENSION | Prescription | ORAL |
| 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | INTRAVENOUS |