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Last Updated: February 27, 2020

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KERYDIN Drug Profile


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When do Kerydin patents expire, and what generic alternatives are available?

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-one 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

See all KERYDIN clinical trials

Recent Litigation for KERYDIN

Identify potential future generic entrants

District Court Litigation
Case NameDate
Anacor Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc.2018-10-29
Anacor Pharmaceuticals, Inc. v. Lupin Limited2018-10-17

See all KERYDIN litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2018-07-10
Mylan Pharmaceuticals Inc.2018-07-06
FlatWing Pharmaceuticals, LLC2017-11-21

See all KERYDIN litigation

Pharmacology for KERYDIN
Synonyms for KERYDIN
1,3-dihydro-5-fluoro-1-hydroxy-2,1-benzoxaborole
174671-46-6
2,1-Benzoxaborole, 5-fluoro-1,3-dihydro-1-hydroxy-
3338AH
5-fluoro-1-hydroxy-3H-2,1-benzoxaborole
5-Fluoro-1-hydroxyl-1,3-dihydrobenzo[c][1,2]oxaborole
5-Fluoro-1,3-dihydro-1-hydroxy-2,1-benzoxaborole
5-fluoro-1,3-dihydro-2,1-benzoxaborol-1-ol
5-fluoro-2,1-benzoxaborol-1(3H)-ol
5-Fluoro-3H-benzo[c][1,2)oxaborol-1-ol
5-fluoro-3H-benzo[c][1,2]oxaborol-1-ol
5-FLUOROBENZO[C][1,2]OXABOROL-1(3H)-OL
AK163946
AKOS006303927
AN 2690
AN-2690
AN-2690(Tavaborole)
AN2690
BCP08730
BDBM50370987
C7H6BFO2
CHEBI:77942
CHEMBL443052
CS-1058
CTK8H2675
D10169
DB09041
DS-8392
DTXSID00169888
EX-A1086
FT-0697827
HSDB 8342
HY-10980
K124A4EUQ3
KB-74687
Kerydin (TN)
KS-00000SPV
LFQDNHWZDQTITF-UHFFFAOYSA-N
MB08883
MFCD10699483 (95%)
MolPort-027-845-281
NCGC00264110-01
SCH-900340
SCHEMBL500016
ST24044751
SY038332
Tavaborole
Tavaborole (USAN)
Tavaborole [USAN:INN]
UNII-K124A4EUQ3
W-5454
X3699
Z1739256284
ZINC169990691
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   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
Anacor Pharms Inc KERYDIN tavaborole SOLUTION;TOPICAL 204427-001 Jul 7, 2014 RX Yes Yes   Start Trial   Start Trial   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

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