Naftin is a drug owned by Sebela Ireland Ltd. It is protected by 6 US drug patents filed from 2014 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 31, 2033. Details of Naftin'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). | |||
| US9161914 | Topical compositions and methods for making and using same |
Jan, 2033
(8 years from now) | Active |
| US10729667 | Topical compositions and methods for making and using same |
Jan, 2033
(8 years from now) | Active |
| US8778365 | Topical compositions and methods for making and using same |
Jan, 2033
(8 years from now) | Active |
| US10695303 | Topical compositions and methods for making and using same |
Jan, 2033
(8 years from now) | Active |
| US10166206 | Topical compositions and methods for making and using same |
Jan, 2033
(8 years from now) | Active |
| US10166205 | Topical compositions and methods for making and using same |
Jan, 2033
(8 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 Naftin's patents.
Latest Legal Activities on Naftin's Patents
Given below is the list of recent legal activities going on the following patents of Naftin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 17 Jan, 2024 | US10729667 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 13 Dec, 2023 | US10695303 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 05 Apr, 2023 | US9161914 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 15 Jun, 2022 | US10166205 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 15 Jun, 2022 | US10166206 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 29 Dec, 2021 | US8778365 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 Jul, 2021 | US10729667 |
| Email Notification Critical | 06 Jul, 2021 | US10729667 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Jul, 2021 | US10166206 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Jul, 2021 | US10166205 |
FDA has granted several exclusivities to Naftin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Naftin, 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 Naftin.
Exclusivity Information
Naftin holds 3 exclusivities. All of its exclusivities have expired in 2019. Details of Naftin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | Jan 13, 2015 |
| New Product(NP) | Jun 27, 2016 |
| M(M-191) | Nov 10, 2019 |
US patents provide insights into the exclusivity only within the United States, but Naftin 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 Naftin's family patents as well as insights into ongoing legal events on those patents.
Naftin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Naftin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 31, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Naftin Generic API suppliers:
Naftifine Hydrochloride is the generic name for the brand Naftin. 3 different companies have already filed for the generic of Naftin, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Naftin's generic
How can I launch a generic of Naftin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Naftin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Naftin'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 Naftin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.02 | 04 Feb, 2015 | 1 | 10 Apr, 2019 | 31 Jan, 2033 | Deferred |
Alternative Brands for Naftin
Naftin 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.
About Naftin
Naftin is a drug owned by Sebela Ireland Ltd. It is used for treating fungal infections. Naftin uses Naftifine Hydrochloride as an active ingredient. Naftin was launched by Sebela Ireland Ltd in 2013.
Approval Date:
Naftin was approved by FDA for market use on 27 June, 2013.
Active Ingredient:
Naftin uses Naftifine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Naftifine Hydrochloride ingredient
Treatment:
Naftin is used for treating fungal infections.
Dosage:
Naftin is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2% | GEL | Prescription | TOPICAL |