Luzu is a drug owned by Bausch Health Us Llc. It is protected by 5 US drug patents filed from 2013 to 2016. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 28, 2034. Details of Luzu's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US5900488 | Method for treating mycosis using imidazolylacetonitrile derivatives |
Jan, 2020
(4 years ago) |
Expired
|
| US9012484 | Crystal and pharmaceutical preparation containing the same crystal |
Sep, 2033
(9 years from now) | Active |
| US9453006 | Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient |
Sep, 2033
(9 years from now) | Active |
| US9199977 | Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal |
Sep, 2033
(9 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8980931 | Method of evaluating pharmaceutical preparation containing luliconazole and index substance |
Apr, 2034
(9 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 Luzu's patents.
Latest Legal Activities on Luzu's Patents
Given below is the list of recent legal activities going on the following patents of Luzu.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Feb, 2024 | US9453006 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 May, 2023 | US9199977 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Sep, 2022 | US9012484 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Mar, 2020 | US9453006 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 May, 2019 | US9199977 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Oct, 2018 | US9012484 |
| Mail Post Card | 23 Aug, 2018 | US9012484 |
| Patent Issue Date Used in PTA Calculation | 27 Sep, 2016 | US9453006 |
| Recordation of Patent Grant Mailed | 27 Sep, 2016 | US9453006 |
| Email Notification | 08 Sep, 2016 | US9453006 |
FDA has granted several exclusivities to Luzu. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Luzu, 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 Luzu.
Exclusivity Information
Luzu holds 2 exclusivities. All of its exclusivities have expired in 2021. Details of Luzu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 14, 2018 |
| New Patient Population(NPP) | Feb 20, 2021 |
US patents provide insights into the exclusivity only within the United States, but Luzu 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 Luzu's family patents as well as insights into ongoing legal events on those patents.
Luzu's family patents
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Generic Launch
Generic Release Date:
Luzu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 28, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Luzu Generics:
There are no approved generic versions for Luzu as of now.
About Luzu
Luzu is a drug owned by Bausch Health Us Llc. It is used for treating fungal infections. Luzu uses Luliconazole as an active ingredient. Luzu was launched by Bausch in 2013.
Market Authorisation Date:
Luzu was approved by FDA for market use on 14 November, 2013.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Luzu is 14 November, 2013, its NCE-1 date is estimated to be 14 November, 2017
Active Ingredient:
Luzu uses Luliconazole as the active ingredient. Check out other Drugs and Companies using Luliconazole ingredient
Treatment:
Luzu is used for treating fungal infections.
Dosage:
Luzu is available in cream form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | CREAM | Prescription | TOPICAL |