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Last Updated: July 8, 2020

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 and one Paragraph IV challenge. Additional details are available on the KERYDIN profile page.

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.
Summary for 204427
Applicant:Anacor Pharms Inc
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 204427
Generic Entry Date for 204427*:
Constraining patent/regulatory exclusivity:

*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.

Pharmacology for NDA: 204427
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 10337-905-10 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-10) > 10 mL in 1 BOTTLE, WITH APPLICATOR
KERYDIN tavaborole SOLUTION;TOPICAL 204427 NDA PharmaDerm, A division of Fougera Pharmaceuticals Inc. 10337-905 10337-905-44 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10337-905-44) > 4 mL in 1 BOTTLE, WITH APPLICATOR
Paragraph IV (Patent) Challenges for 204427
Tradename Dosage Ingredient NDA Submissiondate
KERYDIN SOLUTION;TOPICAL tavaborole 204427 2018-07-09

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength5%
Approval Date:Jul 7, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 7, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:  Start TrialPatent Expiration:Nov 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Aug 16, 2026Product Flag?Substance Flag?Delist Request?Y

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