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Last Updated: April 13, 2024

Efinaconazole - Generic Drug Details


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What are the generic sources for efinaconazole and what is the scope of freedom to operate?

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

SponsorPhase
Dong-A ST Co., Ltd.Phase 4
Western University of Health SciencesPhase 3
Valeant Pharmaceuticals International, Inc.Phase 4

See all efinaconazole clinical trials

Generic filers with tentative approvals for EFINACONAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial10%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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus EFINACONAZOLE efinaconazole SOLUTION;TOPICAL 212178-001 Jul 15, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for efinaconazole

Country Patent Number Title Estimated Expiration
Japan 5872656 ⤷  Try a Trial
Japan 5623913 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013005434 ⤷  Try a Trial
Malaysia 179756 STABILIZED EFINACONAZOLE FORMULATIONS ⤷  Try a Trial
Japan 6516759 ⤷  Try a Trial
Russian Federation 2519664 КОМПОЗИЦИИ И СПОСОБЫ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ НОГТЕЙ (COMPOSITIONS AND METHODS OF TREATING NAIL DISEASES) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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