Xepi is a drug owned by Ferrer Internacional Sa. It is protected by 3 US drug patents filed in 2018. Out of these, 2 drug patents are active and 1 has expired. Xepi's patents have been open to challenges since 11 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 29, 2032. Details of Xepi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6335447 | Quinolonecarboxylic acid derivatives or salts thereof |
Nov, 2023
(1 year, 11 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9180200 | Pharmaceutical topical compositions |
Jan, 2032
(6 years from now) | Active |
| US9399014 | Pharmaceutical topical compositions |
Dec, 2029
(4 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 Xepi's patents.
Latest Legal Activities on Xepi's Patents
Given below is the list of recent legal activities going on the following patents of Xepi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jan, 2024 | US9399014 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 27 Jan, 2020 | US9399014 |
| Recordation of Patent Grant Mailed
Critical | 26 Jul, 2016 | US9399014 |
| Patent Issue Date Used in PTA Calculation
Critical | 26 Jul, 2016 | US9399014 |
| Email Notification
Critical | 06 Jul, 2016 | US9399014 |
| Issue Notification Mailed
Critical | 05 Jul, 2016 | US9399014 |
| Dispatch to FDC | 23 Jun, 2016 | US9399014 |
| Application Is Considered Ready for Issue
Critical | 22 Jun, 2016 | US9399014 |
| Issue Fee Payment Verified
Critical | 22 Jun, 2016 | US9399014 |
| Issue Fee Payment Received
Critical | 22 Jun, 2016 | US9399014 |
FDA has granted several exclusivities to Xepi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Xepi, 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
Xepi.
Exclusivity Information
Xepi holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Xepi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 11, 2022 |
US patents provide insights into the exclusivity only within the United States, but
Xepi 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 Xepi's family patents as well as insights into
ongoing legal events
on those patents.
Xepi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xepi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 29, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xepi Generics:
There are no approved generic versions for Xepi as of now.
Alternative Brands for Xepi
Xepi which is used for treating impetigo caused by Staphylococcus aureus or Streptococcus pyogenes., 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 | ||
|---|---|---|---|---|
| Almirall |
| |||
About Xepi
Xepi is a drug owned by Ferrer Internacional Sa. It is used for treating impetigo caused by Staphylococcus aureus or Streptococcus pyogenes. Xepi uses Ozenoxacin as an active ingredient. Xepi was launched by Ferrer Internacional in 2017.
Approval Date:
Xepi was approved by FDA for market use on 11 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xepi is 11 December, 2017, its NCE-1 date is estimated to be 11 December, 2021.
Active Ingredient:
Xepi uses Ozenoxacin as the active ingredient. Check out other Drugs and Companies using Ozenoxacin ingredient
Treatment:
Xepi is used for treating impetigo caused by Staphylococcus aureus or Streptococcus pyogenes.
Dosage:
Xepi is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Discontinued | TOPICAL |