Luzu Patent Expiration

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. Luzu's patents have been open to challenges since 14 November, 2017. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US9012484 Crystal and pharmaceutical preparation containing the same crystal
Sep, 2033

(8 years from now)

Active
US9453006 Crystalline form having specific crystal habit and pharmaceutical composition containing this crystalline form as active ingredient
Sep, 2033

(8 years from now)

Active
US9199977 Crystal having crystal habits and pharmaceutical composition obtained by processing the crystal
Sep, 2033

(8 years from now)

Active
US5900488 Method for treating mycosis using imidazolylacetonitrile derivatives
Jan, 2020

(4 years ago)

Expired
These drug patents focus on the other aspects of the drug 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.

Given below is the list of recent legal activities going on the following patents of Luzu.

Activity Date Patent Number
Patent litigations
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

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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

Luzu has patent protection in a total of 7 countries. It's US patent count contributes only to 11.5% of its total global patent coverage. Click below to unlock the full patent family tree for Luzu.

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.

Alternative Brands for Luzu

Luzu which is used for treating fungal infections., 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
Pf Prism Cv
Vfend used for treating fungal infections.
Sebela Ireland Ltd
Naftin Used for treating fungal infections.
Vicuron Holdings
Eraxis Used for treating fungal infections.





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.

Approval Date:

Luzu was approved by FDA for market use on 14 November, 2013.

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 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