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Last Updated: May 28, 2024

Efinaconazole - Generic Drug Details

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What are the generic drug sources for efinaconazole and what is the scope of patent protection?

Efinaconazole is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Lupin Ltd, Nivagen Pharms Inc, Padagis Us, Teva Pharms Usa, Zydus, and Bausch, and is included in seven NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty-four patent family members in twenty-four countries.

There are fourteen drug master file entries for efinaconazole. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for efinaconazole

Identify potential brand extensions & 505(b)(2) entrants

Dong-A ST Co., Ltd.Phase 4
Western University of Health SciencesPhase 3
Bausch Health Americas, Inc.Phase 4

See all efinaconazole clinical trials

Generic filers with tentative approvals for EFINACONAZOLE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10%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 efinaconazole
Drug ClassAzole Antifungal
Paragraph IV (Patent) Challenges for EFINACONAZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JUBLIA Topical Solution efinaconazole 10% 203567 19 2018-06-06

US Patents and Regulatory Information for efinaconazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Nivagen Pharms Inc EFINACONAZOLE efinaconazole SOLUTION;TOPICAL 211969-001 Jun 21, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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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 verification 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.