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Last Updated: February 26, 2021

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Tavaborole - Generic Drug Details

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What are the generic drug sources for tavaborole and what is the scope of freedom to operate?

Tavaborole is the generic ingredient in two branded drugs marketed by Anacor Pharms Inc, Aleor Dermaceuticals, Amneal, Encube, and Perrigo Pharma Intl, and is included in five NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Tavaborole has eighty-five patent family members in twenty-three countries.

There are six drug master file entries for tavaborole. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for tavaborole

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SponsorPhase
PfizerPhase 4

See all tavaborole clinical trials

Generic filers with tentative approvals for TAVABOROLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5%SOLUTION;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for tavaborole

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 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Perrigo Pharma Intl TAVABOROLE tavaborole SOLUTION;TOPICAL 211848-001 Oct 13, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Encube TAVABOROLE tavaborole SOLUTION;TOPICAL 211297-001 Oct 13, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 AB 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 tavaborole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2343304 PA2020524 Lithuania   Start Trial PRODUCT NAME: KRISABOROLAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS FORMOJE; REGISTRATION NO/DATE: EU/1/19/1421 20200327
2343304 2020/024 Ireland   Start Trial PRODUCT NAME: CRISABOROLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/19/1421/001 EU/1/19/1421/004 20200327
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
2343304 CR 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
2343304 2020C/531 Belgium   Start Trial PRODUCT NAME: CRISABOROLE, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1421 20200401
2343304 301049 Netherlands   Start Trial PRODUCT NAME: CRISABOROLE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1421 20200401
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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