Children's Zyrtec Allergy is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 02, 2018. Details of Children's Zyrtec Allergy'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). | |||
| US6455533 | Pharmaceutical compositions for oral administration, comprising an active substance and a cyclodextrin |
Jul, 2018
(6 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Children's Zyrtec Allergy 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 Children's Zyrtec Allergy's family patents as well as insights into ongoing legal events on those patents.
Children's Zyrtec Allergy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Children's Zyrtec Allergy's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 02, 2018 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Children's Zyrtec Allergy Generics:
There are no approved generic versions for Children's Zyrtec Allergy as of now.
How can I launch a generic of Children's Zyrtec Allergy before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Children's Zyrtec Allergy's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Children's Zyrtec Allergy'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 Children's Zyrtec Allergy -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 25 Mar, 2005 |
About Children's Zyrtec Allergy
Children'S Zyrtec Allergy is a drug owned by Johnson And Johnson Consumer Inc Mcneil Consumer Healthcare Div. It is used for treating symptoms of seasonal and perennial allergic rhinitis. Children'S Zyrtec Allergy uses Cetirizine Hydrochloride as an active ingredient. Children'S Zyrtec Allergy was launched by J And J Consumer Inc in 2020.
Approval Date:
Children's Zyrtec Allergy was approved by FDA for market use on 30 November, 2020.
Active Ingredient:
Children's Zyrtec Allergy uses Cetirizine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cetirizine Hydrochloride ingredient
Treatment:
Children's Zyrtec Allergy is used for treating symptoms of seasonal and perennial allergic rhinitis.
Dosage:
Children's Zyrtec Allergy is available in tablet, chewable form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE | Over the counter | ORAL |
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, CHEWABLE | Discontinued | ORAL |