Kerydin is a drug owned by Anacor Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2014 to 2018 out of which none have expired yet. Kerydin's patents have been open to challenges since 07 January, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 26, 2027. Details of Kerydin'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). | |||
|
US7582621 (Pediatric) | Boron-containing small molecules |
Nov, 2027
(2 years from now) | Active |
| US7582621 | Boron-containing small molecules |
May, 2027
(2 years from now) | Active |
| US7767657 | Boron-containing small molecules |
May, 2027
(2 years from now) | Active |
|
US9549938 (Pediatric) | Boron-containing small molecules |
Aug, 2026
(1 year, 7 months from now) | Active |
|
US9566290 (Pediatric) | Boron-containing small molecules |
Aug, 2026
(1 year, 7 months from now) | Active |
|
US9572823 (Pediatric) | Boron-containing small molecules |
Aug, 2026
(1 year, 7 months from now) | Active |
|
US9566289 (Pediatric) | Boron-containing small molecules |
Aug, 2026
(1 year, 7 months from now) | Active |
| US9566289 | Boron-containing small molecules |
Feb, 2026
(1 year, 1 month from now) | Active |
| US9572823 | Boron-containing small molecules |
Feb, 2026
(1 year, 1 month from now) | Active |
| US9566290 | Boron-containing small molecules |
Feb, 2026
(1 year, 1 month from now) | Active |
| US9549938 | Boron-containing small molecules |
Feb, 2026
(1 year, 1 month 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 Kerydin's patents.
Latest Legal Activities on Kerydin's Patents
Given below is the list of recent legal activities going on the following patents of Kerydin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Application Return from OIPE | 18 Jul, 2022 | US9566290 |
| Correspondence Address Change Critical | 18 Jul, 2022 | US9566290 |
| Application Return TO OIPE | 18 Jul, 2022 | US9566290 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jan, 2022 | US7767657 |
| Maintenance Fee Reminder Mailed Critical | 19 Apr, 2021 | US7582621 |
| Review Certificate Mailed | 16 Apr, 2021 | US9572823 |
| Review Certificate Mailed | 08 Apr, 2021 | US9566289 |
| Review Certificate Mailed | 08 Apr, 2021 | US9549938 |
| Review Certificate Mailed | 08 Apr, 2021 | US9566290 |
| Review Certificate | 19 Mar, 2021 | US9566290 |
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 Kerydin and ongoing litigations to help you estimate the early arrival of Kerydin generic.
Kerydin's Litigations
Kerydin been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 20, 2015, against patent number US7767657. The petitioner Coalition for Affordable Drugs X, LLC, challenged the validity of this patent, with Anacor Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Kerydin's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9549938 | November, 2017 |
FWD Entered
(05 Jun, 2019) | Anacor Pharmaceuticals, Inc. | FlatWing Pharmaceuticals, LLC |
| US9566289 | November, 2017 |
FWD Entered
(05 Jun, 2019) | Anacor Pharmaceuticals, Inc. | FlatWing Pharmaceuticals, LLC |
| US9566290 | November, 2017 |
FWD Entered
(05 Jun, 2019) | Anacor Pharmaceuticals, Inc. | FlatWing Pharmaceuticals, LLC |
| US9572823 | November, 2017 |
FWD Entered
(05 Jun, 2019) | Anacor Pharmaceuticals, Inc. | FlatWing Pharmaceuticals, LLC |
| US9549938 | July, 2018 |
Terminated
(11 Oct, 2018) | Pfizer Inc. | Mylan Pharmaceuticals Inc. et al. |
| US9566289 | July, 2018 |
Terminated
(11 Oct, 2018) | Pfizer Inc. | Mylan Pharmaceuticals Inc. et al. |
| US9566290 | July, 2018 |
Terminated
(11 Oct, 2018) | Pfizer Inc. | Mylan Pharmaceuticals Inc. et al. |
| US9572823 | July, 2018 |
Terminated
(11 Oct, 2018) | Pfizer Inc. | Mylan Pharmaceuticals Inc. et al. |
| US7582621 | August, 2015 |
FWD Entered
(23 Feb, 2017) | Anacor Pharmaceuticals, Inc. | Coalition for Affordable Drugs X LLC |
| US7767657 | August, 2015 |
FWD Entered
(23 Feb, 2017) | Anacor Pharmaceuticals, Inc. | Coalition for Affordable Drugs X, LLC |
FDA has granted some exclusivities to Kerydin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kerydin, 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 Kerydin.
Exclusivity Information
Kerydin holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Kerydin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 07, 2019 |
| Pediatric Exclusivity(PED) | Jan 07, 2020 |
US patents provide insights into the exclusivity only within the United States, but Kerydin 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 Kerydin's family patents as well as insights into ongoing legal events on those patents.
Kerydin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kerydin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 26, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kerydin Generic API suppliers:
Tavaborole is the generic name for the brand Kerydin. 9 different companies have already filed for the generic of Kerydin, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Kerydin's generic
How can I launch a generic of Kerydin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Kerydin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Kerydin'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 Kerydin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.05 | 09 Jul, 2018 | 13 | 13 Oct, 2020 | 26 May, 2027 | Eligible |
About Kerydin
Kerydin is a drug owned by Anacor Pharmaceuticals Inc. It is used for treating onychomycosis (fungal infection of the toenail). Kerydin uses Tavaborole as an active ingredient. Kerydin was launched by Anacor Pharms Inc in 2014.
Approval Date:
Kerydin was approved by FDA for market use on 07 July, 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 Kerydin is 07 July, 2014, its NCE-1 date is estimated to be 07 January, 2019.
Active Ingredient:
Kerydin uses Tavaborole as the active ingredient. Check out other Drugs and Companies using Tavaborole ingredient
Treatment:
Kerydin is used for treating onychomycosis (fungal infection of the toenail).
Dosage:
Kerydin is available in solution form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5% | SOLUTION | Discontinued | TOPICAL |