Jublia is a drug owned by Bausch Health Americas Inc. It is protected by 18 US drug patents filed from 2014 to 2024 out of which none have expired yet. Jublia's patents have been open to challenges since 06 June, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 25, 2035. Details of Jublia'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). | |||
| US10478601 | Applicator |
Apr, 2035
(10 years from now) | Active |
| US10342875 | Stabilized efinaconazole compositions |
Oct, 2034
(9 years from now) | Active |
| US10828293 | Anti-infective methods, compositions, and devices |
Oct, 2034
(9 years from now) | Active |
| US11654139 | Anti-infective methods, compositions, and devices |
Oct, 2034
(9 years from now) | Active |
| US10864274 | Stabilized efinaconazole formulations |
Oct, 2034
(9 years from now) | Active |
| US9662394 | Stabilized efinaconazole compositions |
Oct, 2034
(9 years from now) | Active |
| US9302009 | Compositions and methods for treating diseases of the nail |
Oct, 2030
(5 years from now) | Active |
| US8486978 | Compositions and methods for treating diseases of the nail |
Oct, 2030
(5 years from now) | Active |
| US10105444 | Compositions and methods for treating diseases of the nail |
Jul, 2030
(5 years from now) | Active |
| US9861698 | Compositions and methods for treating diseases of the nail |
Jul, 2030
(5 years from now) | Active |
| US8039494 | Compositions and methods for treating diseases of the nail |
Jul, 2030
(5 years from now) | Active |
| US11872218 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US9566272 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US9877955 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US10512640 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US11213519 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US10828369 | Compositions and methods for treating diseases of the nail |
Jan, 2028
(3 years from now) | Active |
| US7214506 | Method for treating onychomycosis |
Feb, 2026
(1 year, 3 months 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 Jublia's patents.
Latest Legal Activities on Jublia's Patents
Given below is the list of recent legal activities going on the following patents of Jublia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 May, 2024 | US10864274 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Apr, 2024 | US10828293 |
| Recordation of Patent Grant Mailed Critical | 16 Jan, 2024 | US11872218 |
| Patent eGrant Notification | 16 Jan, 2024 | US11872218 |
| Recordation of Patent eGrant | 16 Jan, 2024 | US11872218 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Jan, 2024 | US11872218 |
| Email Notification Critical | 16 Jan, 2024 | US11872218 |
| Mail Patent eGrant Notification | 16 Jan, 2024 | US11872218 |
| Email Notification Critical | 28 Dec, 2023 | US11872218 |
| Issue Notification Mailed Critical | 27 Dec, 2023 | US11872218 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Jublia and ongoing litigations to help you estimate the early arrival of Jublia generic.
Jublia's Litigations
Jublia been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 12, 2017, against patent number US7214506. The petitioner Argentum Pharmaceuticals LLC et al., challenged the validity of this patent, with Kaken Pharmaceutical Co., Ltd. et al. as the respondent. Click below to track the latest information on how companies are challenging Jublia's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7214506 | November, 2016 |
FWD Entered
(06 Jun, 2018) | Kaken Pharmaceutical Co., Ltd. | Acrux DDS Pty Ltd. |
| US7214506 | May, 2017 |
Terminated-Settled
(13 Nov, 2017) | Kaken Pharmaceutical Co., Ltd. et al. | Argentum Pharmaceuticals LLC et al. |
FDA has granted some exclusivities to Jublia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jublia, 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 Jublia.
Exclusivity Information
Jublia holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Jublia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 06, 2019 |
| New Patient Population(NPP) | Apr 27, 2023 |
US patents provide insights into the exclusivity only within the United States, but Jublia 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 Jublia's family patents as well as insights into ongoing legal events on those patents.
Jublia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jublia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 25, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jublia Generic API suppliers:
Efinaconazole is the generic name for the brand Jublia. 6 different companies have already filed for the generic of Jublia, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Jublia's generic
How can I launch a generic of Jublia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jublia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jublia'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 Jublia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 | 06 Jun, 2018 | 19 | 16 Dec, 2020 | 02 Oct, 2034 | Eligible |
About Jublia
Jublia is a drug owned by Bausch Health Americas Inc. It is used for treating onychomycosis and tinea unguium. Jublia uses Efinaconazole as an active ingredient. Jublia was launched by Bausch in 2014.
Approval Date:
Jublia was approved by FDA for market use on 06 June, 2014.
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 Jublia is 06 June, 2014, its NCE-1 date is estimated to be 06 June, 2018.
Active Ingredient:
Jublia uses Efinaconazole as the active ingredient. Check out other Drugs and Companies using Efinaconazole ingredient
Treatment:
Jublia is used for treating onychomycosis and tinea unguium.
Dosage:
Jublia is available in solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10% | SOLUTION | Prescription | TOPICAL |