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Last Updated: July 12, 2020

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KERYDIN Drug Profile


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When do Kerydin patents expire, and when can generic versions of Kerydin launch?

Kerydin is a drug marketed by Anacor Pharms Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in twenty-one countries.

The generic ingredient in KERYDIN is tavaborole. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tavaborole profile page.

US ANDA Litigation and Generic Entry Outlook for Kerydin

Kerydin was eligible for patent challenges on July 7, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2026. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (tavaborole), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for KERYDIN
Drug Prices for KERYDIN

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Generic Entry Opportunity Date for KERYDIN
Generic Entry Date for KERYDIN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for KERYDIN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PfizerPhase 4

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Pharmacology for KERYDIN
Paragraph IV (Patent) Challenges for KERYDIN
Tradename Dosage Ingredient NDA Submissiondate
KERYDIN SOLUTION;TOPICAL tavaborole 204427 2018-07-09

US Patents and Regulatory Information for KERYDIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for KERYDIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2343304 CA 2020 00022 Denmark   Start Trial PRODUCT NAME: CRISABOROLE, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1421 20200401
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Merck
Baxter
Express Scripts
Boehringer Ingelheim
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.