Zilxi is a drug owned by Journey Medical Corp. It is protected by 8 US drug patents filed from 2020 to 2021 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 01, 2030. Details of Zilxi'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). | |||
| US10213512 | Topical tetracycline compositions |
Oct, 2030
(5 years from now) | Active |
| US8992896 | Topical tetracycline compositions |
Oct, 2030
(5 years from now) | Active |
| US9675700 | Topical tetracycline compositions |
Oct, 2030
(5 years from now) | Active |
| US8865139 | Topical tetracycline compositions |
Oct, 2030
(5 years from now) | Active |
| US10322186 | Topical tetracycline compositions |
Oct, 2030
(5 years from now) | Active |
| US10946101 | Surfactant-free water-free foamable compositions, breakable foams and gels and their uses |
Oct, 2030
(5 years from now) | Active |
| US10265404 | Compositions, gels and foams with rheology modulators and uses thereof |
Oct, 2030
(5 years from now) | Active |
| US8945516 | Surfactant-free water-free foamable compositions, breakable foams and gels and their uses |
Oct, 2030
(5 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 Zilxi's patents.
Latest Legal Activities on Zilxi's Patents
Given below is the list of recent legal activities going on the following patents of Zilxi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 19 Dec, 2022 | US10322186 |
| Recordation of Patent Grant Mailed Critical | 16 Mar, 2021 | US10946101 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Mar, 2021 | US10946101 |
| Email Notification Critical | 26 Feb, 2021 | US10946101 |
| Issue Notification Mailed Critical | 24 Feb, 2021 | US10946101 |
| Dispatch to FDC | 12 Feb, 2021 | US10946101 |
| Application Is Considered Ready for Issue Critical | 11 Feb, 2021 | US10946101 |
| Issue Fee Payment Received Critical | 10 Feb, 2021 | US10946101 |
| Issue Fee Payment Verified Critical | 10 Feb, 2021 | US10946101 |
| Email Notification Critical | 11 Jan, 2021 | US10946101 |
US patents provide insights into the exclusivity only within the United States, but Zilxi 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 Zilxi's family patents as well as insights into ongoing legal events on those patents.
Zilxi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zilxi's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 01, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zilxi Generic API suppliers:
Minocycline Hydrochloride is the generic name for the brand Zilxi. 26 different companies have already filed for the generic of Zilxi, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zilxi's generic
How can I launch a generic of Zilxi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Zilxi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Zilxi'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 Zilxi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.015 | 28 Feb, 2022 | 1 | 01 Oct, 2030 |
Alternative Brands for Zilxi
Zilxi which is used for treating inflammatory lesions of rosacea., has several other brand drugs in the same treatment category and using the same active ingredient (Minocycline Hydrochloride). 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 | ||
|---|---|---|---|---|
| Galderma Labs Lp |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Minocycline Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Bausch |
| ||
| Epi Hlth |
| ||
| Journey |
| ||
| Orapharma |
| ||
| Rempex |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Minocycline Hydrochloride, Zilxi's active ingredient. Check the complete list of approved generic manufacturers for Zilxi
About Zilxi
Zilxi is a drug owned by Journey Medical Corp. It is used for treating inflammatory lesions of rosacea. Zilxi uses Minocycline Hydrochloride as an active ingredient. Zilxi was launched by Journey in 2020.
Can you believe Zilxi received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Zilxi was approved by FDA for market use on 28 May, 2020.
Active Ingredient:
Zilxi uses Minocycline Hydrochloride as the active ingredient. Check out other Drugs and Companies using Minocycline Hydrochloride ingredient
Treatment:
Zilxi is used for treating inflammatory lesions of rosacea.
Dosage:
Zilxi is available in aerosol, foam form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 1.5% BASE | AEROSOL, FOAM | Prescription | TOPICAL |