Xyzal Allergy 24hr is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is protected by 1 US drug patent filed in 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 16, 2027. Details of Xyzal Allergy 24hr'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). | |||
| US8633194 | Pharmaceutical composition of piperazine derivatives |
Oct, 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 Xyzal Allergy 24hr's patents.
Latest Legal Activities on Xyzal Allergy 24hr's Patents
Given below is the list of recent legal activities going on the following patents of Xyzal Allergy 24hr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Review Certificate Mailed | 16 Aug, 2021 | US8633194 |
| Review Certificate | 22 Jul, 2021 | US8633194 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Jul, 2021 | US8633194 |
| Termination or Final Written Decision | 09 Jun, 2020 | US8633194 |
| Request for Trial Granted Critical | 15 Jul, 2019 | US8633194 |
| Petition Requesting Trial | 13 Dec, 2018 | US8633194 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jan, 2014 | US8633194 |
| Recordation of Patent Grant Mailed Critical | 21 Jan, 2014 | US8633194 |
| Issue Notification Mailed Critical | 31 Dec, 2013 | US8633194 |
| Dispatch to FDC | 20 Dec, 2013 | US8633194 |
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 Xyzal Allergy 24hr and ongoing litigations to help you estimate the early arrival of Xyzal Allergy 24hr generic.
Xyzal Allergy 24hr's Litigations
Xyzal Allergy 24hr been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 13, 2018, against patent number US8633194. The petitioner Apotex Inc. et al., challenged the validity of this patent, with UCB Biopharma Sprl et al. as the respondent. Click below to track the latest information on how companies are challenging Xyzal Allergy 24hr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8633194 | December, 2018 |
Final Written Decision
(09 Jun, 2020) | UCB Biopharma Sprl et al. | Apotex Inc. et al. |
Several oppositions have been filed on Xyzal Allergy 24hr's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xyzal Allergy 24hr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xyzal Allergy 24hr patents.
Xyzal Allergy 24hr's Oppositions Filed in EPO
Xyzal Allergy 24hr has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 23, 2010, by Zentiva K.S.. This opposition was filed on patent number EP05758582A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP05758582A | Jun, 2010 | Zentiva k.s. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Xyzal Allergy 24hr 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 Allergy 24hr's family patents as well as insights into ongoing legal events on those patents.
Xyzal Allergy 24hr's Family Patents
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Generic Launch
Generic Release Date:
Xyzal Allergy 24hr's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 16, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xyzal Allergy 24hr Generic API suppliers:
Levocetirizine Dihydrochloride is the generic name for the brand Xyzal Allergy 24hr. 20 different companies have already filed for the generic of Xyzal Allergy 24hr, 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 Allergy 24hr's generic
How can I launch a generic of Xyzal Allergy 24hr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xyzal Allergy 24hr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xyzal Allergy 24hr'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 Allergy 24hr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.5 mg/mL | 04 Jan, 2018 | 1 | Deferred |
Alternative Brands for Xyzal Allergy 24hr
There are several other brand drugs using the same active ingredient (Levocetirizine Dihydrochloride) as Xyzal Allergy 24hr. 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 Allergy 24hr's active ingredient. Check the complete list of approved generic manufacturers for Xyzal Allergy 24hr
About Xyzal Allergy 24hr
Xyzal Allergy 24Hr is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. Xyzal Allergy 24Hr uses Levocetirizine Dihydrochloride as an active ingredient. Xyzal Allergy 24Hr was launched by Chattem Sanofi in 2017.
Approval Date:
Xyzal Allergy 24hr was approved by FDA for market use on 31 January, 2017.
Active Ingredient:
Xyzal Allergy 24hr uses Levocetirizine Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Levocetirizine Dihydrochloride ingredient
Dosage:
Xyzal Allergy 24hr is available in solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2.5MG/5ML | SOLUTION | Over the counter | ORAL |