Antizol is a drug owned by Par Pharmaceutical Inc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 30, 2027. Details of Antizol'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. | |||
| US7553863 | Ultrapure 4-methylpyrazole |
Jun, 2027
(2 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 Antizol's patents.
Latest Legal Activities on Antizol's Patents
Given below is the list of recent legal activities going on the following patents of Antizol.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Sep, 2020 | US7553863 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 23 Jun, 2017 | US7553863 |
| Post Issue Communication - Certificate of Correction | 14 Sep, 2009 | US7553863 |
| Recordation of Patent Grant Mailed Critical | 30 Jun, 2009 | US7553863 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Jun, 2009 | US7553863 |
| Email Notification Critical | 12 Jun, 2009 | US7553863 |
| Issue Notification Mailed Critical | 10 Jun, 2009 | US7553863 |
| Dispatch to FDC | 28 May, 2009 | US7553863 |
| Application Is Considered Ready for Issue Critical | 27 May, 2009 | US7553863 |
| Issue Fee Payment Verified Critical | 26 May, 2009 | US7553863 |
US patents provide insights into the exclusivity only within the United States, but Antizol 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 Antizol's family patents as well as insights into ongoing legal events on those patents.
Antizol's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Antizol's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 30, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Antizol Generic API suppliers:
Fomepizole is the generic name for the brand Antizol. 4 different companies have already filed for the generic of Antizol, with Mylan Institutional having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Antizol's generic
How can I launch a generic of Antizol before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Antizol's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Antizol'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 Antizol -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.5 g/1.5 mL | 14 Apr, 2014 | 1 | 30 Jun, 2027 | Extinguished |
About Antizol
Antizol is a drug owned by Par Pharmaceutical Inc. Antizol uses Fomepizole as an active ingredient. Antizol was launched by Par Pharm Inc in 1997.
Approval Date:
Antizol was approved by FDA for market use on 04 December, 1997.
Active Ingredient:
Antizol uses Fomepizole as the active ingredient. Check out other Drugs and Companies using Fomepizole ingredient
Dosage:
Antizol is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |