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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204427

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NDA 204427 describes KERYDIN, which is a drug marketed by Anacor Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the KERYDIN profile page.

The generic ingredient in KERYDIN is tavaborole. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tavaborole profile page.
Summary for 204427
Tradename:KERYDIN
Applicant:Anacor Pharms Inc
Ingredient:tavaborole
Patents:5
Formulation / Manufacturing:see details
Pharmacology for NDA: 204427
Ingredient-typeBoron Compounds
Mechanism of ActionProtein Synthesis Inhibitors
Suppliers and Packaging for NDA: 204427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KERYDIN tavaborole SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 N 10337-905-44
KERYDIN tavaborole SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 N 10337-905-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength5%
Approval Date:Jul 7, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 7, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:May 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT FOR ONYCHOMYCOSIS THAT IS TINEA UNGUIUM
Patent:➤ Try a Free TrialPatent Expiration:Feb 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONYCHOMYCOSIS OF A TOENAIL

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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 verifification 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.

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