Xyzal is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. 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 Jan 26, 2014. Details of Xyzal'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). | |||
|
US5698558 (Pediatric) | Methods for treating allergic disorders using optically pure (-) cetirizine |
Jan, 2014
(10 years ago) |
Expired
|
| US5698558 | Methods for treating allergic disorders using optically pure (-) cetirizine |
Jul, 2013
(11 years ago) |
Expired
|
FDA has granted several exclusivities to Xyzal. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xyzal, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Xyzal.
Exclusivity Information
Xyzal holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Xyzal's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Aug 21, 2012 |
| Pediatric Exclusivity(PED) | Feb 21, 2013 |
US patents provide insights into the exclusivity only within the United States, but Xyzal 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 Xyzal's family patents as well as insights into ongoing legal events on those patents.
Xyzal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xyzal's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 26, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xyzal Generic API suppliers:
Levocetirizine Dihydrochloride is the generic name for the brand Xyzal. 20 different companies have already filed for the generic of Xyzal, with Hetero Labs Ltd Iii having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xyzal's generic
How can I launch a generic of Xyzal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xyzal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xyzal'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 Xyzal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg/mL | 14 Jan, 2009 | 1 | 07 Nov, 2011 | 24 Sep, 2012 | Eligible |
| 5 mg | 17 Dec, 2007 | 1 | 26 Nov, 2010 | 24 Sep, 2012 | Eligible |
Alternative Brands for Xyzal
Xyzal which is used for treating symptoms of seasonal and perennial allergic rhinitis., has several other brand drugs using the same active ingredient (Levocetirizine Dihydrochloride). 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 | |
|---|---|---|
| Chattem Sanofi |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levocetirizine Dihydrochloride, Xyzal's active ingredient. Check the complete list of approved generic manufacturers for Xyzal
About Xyzal
Xyzal is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is used for treating symptoms of seasonal and perennial allergic rhinitis. Xyzal uses Levocetirizine Dihydrochloride as an active ingredient. Xyzal was launched by Chattem Sanofi in 2007.
Approval Date:
Xyzal was approved by FDA for market use on 25 May, 2007.
Active Ingredient:
Xyzal uses Levocetirizine Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Levocetirizine Dihydrochloride ingredient
Treatment:
Xyzal is used for treating symptoms of seasonal and perennial allergic rhinitis.
Dosage:
Xyzal is available in the following dosage forms - solution form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 2.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION | Discontinued | ORAL |