Xerese is a drug owned by Bausch Health Us Llc. It is protected by 3 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 Feb 28, 2021. Details of Xerese'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE39264 | Pharmaceutical combination |
Feb, 2016
(8 years ago) |
Expired
|
| US6514980 | Nucleoside analogs in combination therapy of herpes simplex infections |
Jan, 2017
(7 years ago) |
Expired
|
| US7223387 | Antiviral formulations comprising propylene glycol and an isopropyl alkanoic acid ester |
Feb, 2021
(3 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 Xerese's patents.
Latest Legal Activities on Xerese's Patents
Given below is the list of recent legal activities going on the following patents of Xerese.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Nov, 2018 | US7223387 |
| Correspondence Address Change | 23 Feb, 2012 | US7223387 |
| Change in Power of Attorney (May Include Associate POA) | 23 Feb, 2012 | US7223387 |
| Patent Issue Date Used in PTA Calculation | 29 May, 2007 | US7223387 |
| Recordation of Patent Grant Mailed | 29 May, 2007 | US7223387 |
| Electronic Review | 12 May, 2007 | US7223387 |
| Issue Notification Mailed | 11 May, 2007 | US7223387 |
| Email Notification | 11 May, 2007 | US7223387 |
| Dispatch to FDC | 25 Apr, 2007 | US7223387 |
| Application Is Considered Ready for Issue | 25 Apr, 2007 | US7223387 |
FDA has granted several exclusivities to Xerese. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xerese, 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 Xerese.
Exclusivity Information
Xerese holds 2 exclusivities. All of its exclusivities have expired in 2017. Details of Xerese's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jul 31, 2012 |
| New Patient Population(NPP) | Jan 22, 2017 |
US patents provide insights into the exclusivity only within the United States, but Xerese 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 Xerese's family patents as well as insights into ongoing legal events on those patents.
Xerese's family patents
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Generic Launch
Generic Release Date:
Xerese's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 28, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xerese Generics:
There are no approved generic versions for Xerese as of now.
About Xerese
Xerese is a drug owned by Bausch Health Us Llc. It is used for early treatment of recurrent herpes labialis (cold sores) in adults and adolescents to reduce likelihood of ulcerative cold sores and shorten lesion healing time. Xerese uses Acyclovir; Hydrocortisone as an active ingredient. Xerese was launched by Bausch in 2009.
Market Authorisation Date:
Xerese was approved by FDA for market use on 31 July, 2009.
Active Ingredient:
Xerese uses Acyclovir; Hydrocortisone as the active ingredient. Check out other Drugs and Companies using Acyclovir; Hydrocortisone ingredient
Treatment:
Xerese is used for early treatment of recurrent herpes labialis (cold sores) in adults and adolescents to reduce likelihood of ulcerative cold sores and shorten lesion healing time.
Dosage:
Xerese is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5%;1% | CREAM | Prescription | TOPICAL |