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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Queensland Health
McKesson
Cipla
Fuji
Dow
Merck
Johnson and Johnson
US Army

Generated: June 21, 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 five 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 10337-905-10
KERYDIN tavaborole SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 N 10337-905-44

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:➤ Sign UpPatent Expiration:May 26, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT FOR ONYCHOMYCOSIS THAT IS TINEA UNGUIUM
Patent:➤ Sign UpPatent Expiration:Feb 16, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONYCHOMYCOSIS OF A TOENAIL

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Healthtrust
Chinese Patent Office
Johnson and Johnson
Citi
McKinsey
Daiichi Sankyo
Deloitte
Boehringer Ingelheim

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