Zyrtec-d 12 Hour is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is protected by 4 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 Jun 10, 2022. Details of Zyrtec-d 12 Hour'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). | |||
| US7226614 | Tablet comprising cetirizine and pseudoephedrine |
Jun, 2022
(2 years ago) |
Expired
|
| US7014867 | Tablet comprising cetirizine and pseudoephedrine |
Jun, 2022
(2 years ago) |
Expired
|
| US6469009 | Pharmaceutical compositions for the treatment of rhinitis |
Jul, 2019
(5 years ago) |
Expired
|
| US6489329 | Pharmaceutical compositions for the treatment of rhinitis |
Apr, 2016
(8 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 Zyrtec-d 12 Hour's patents.
Latest Legal Activities on Zyrtec-d 12 Hour's Patents
Given below is the list of recent legal activities going on the following patents of Zyrtec-d 12 Hour.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Nov, 2018 | US7226614 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Sep, 2017 | US7014867 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 05 Jun, 2007 | US7226614 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Jun, 2007 | US7226614 |
| Issue Notification Mailed Critical | 16 May, 2007 | US7226614 |
| Dispatch to FDC | 07 May, 2007 | US7226614 |
| Application Is Considered Ready for Issue Critical | 01 May, 2007 | US7226614 |
| Issue Fee Payment Received Critical | 25 Apr, 2007 | US7226614 |
| Issue Fee Payment Verified Critical | 25 Apr, 2007 | US7226614 |
| Mail Notice of Allowance Critical | 06 Apr, 2007 | US7226614 |
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 Zyrtec-d 12 Hour and ongoing litigations to help you estimate the early arrival of Zyrtec-d 12 Hour generic.
Zyrtec-d 12 Hour's Litigations
Zyrtec-d 12 Hour been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Mar 30, 2001, against patent number US6469009. The petitioner , challenged the validity of this patent, with VAN DE VENNE et al as the respondent. Click below to track the latest information on how companies are challenging Zyrtec-d 12 Hour's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6469009 | March, 2001 |
Decision
(11 Jul, 2002) | VAN DE VENNE et al | |
US patents provide insights into the exclusivity only within the United States, but Zyrtec-d 12 Hour 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 Zyrtec-d 12 Hour's family patents as well as insights into ongoing legal events on those patents.
Zyrtec-d 12 Hour's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zyrtec-d 12 Hour's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 10, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zyrtec-d 12 Hour Generic API suppliers:
Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride is the generic name for the brand Zyrtec-d 12 Hour. 6 different companies have already filed for the generic of Zyrtec-d 12 Hour, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zyrtec-d 12 Hour's generic
How can I launch a generic of Zyrtec-d 12 Hour before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zyrtec-d 12 Hour's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zyrtec-d 12 Hour'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 Zyrtec-d 12 Hour -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg/120 mg | 02 Jun, 2004 | 1 | 25 Feb, 2008 | 13 Jul, 2019 | Extinguished |
Alternative Brands for Zyrtec-d 12 Hour
Zyrtec-d 12 Hour which is used for relieving symptoms of seasonal and perennial allergic rhinitis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||||
|---|---|---|---|---|---|---|
| J And J Consumer Inc |
| |||||
About Zyrtec-d 12 Hour
Zyrtec-D 12 Hour is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is used for relieving symptoms of seasonal and perennial allergic rhinitis. Zyrtec-D 12 Hour uses Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride as an active ingredient. Zyrtec-D 12 Hour was launched by J And J Consumer Inc in 2007.
Approval Date:
Zyrtec-d 12 Hour was approved by FDA for market use on 09 November, 2007.
Active Ingredient:
Zyrtec-d 12 Hour uses Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cetirizine Hydrochloride; Pseudoephedrine Hydrochloride ingredient
Treatment:
Zyrtec-d 12 Hour is used for relieving symptoms of seasonal and perennial allergic rhinitis.
Dosage:
Zyrtec-d 12 Hour is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG;120MG | TABLET, EXTENDED RELEASE | Over the counter | ORAL |