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Last Updated: November 26, 2022

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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efinaconazole has eighty 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
See Plans and PricingSee Plans and Pricing10%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
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Zydus EFINACONAZOLE efinaconazole SOLUTION;TOPICAL 212178-001 Jul 15, 2022 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd EFINACONAZOLE efinaconazole SOLUTION;TOPICAL 212169-001 Mar 2, 2022 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nivagen Pharms Inc EFINACONAZOLE efinaconazole SOLUTION;TOPICAL 211969-001 Jun 21, 2021 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch JUBLIA efinaconazole SOLUTION;TOPICAL 203567-001 Jun 6, 2014 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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
Brazil PI0822162 Método para tratamento de doenças das unhas ou leito ungueal e composição farmacêutica para tratamento tópico de doença das unhas ou leito ungueal. See Plans and Pricing
Canada 3052643 PROCEDES, COMPOSITIONS ET DISPOSITIFS ANTI-INFECTIEUX (ANTI-INFECTIVE METHODS, COMPOSITIONS, AND DEVICES) See Plans and Pricing
Japan 6774518 See Plans and Pricing
Austria 434667 See Plans and Pricing
Canada 2706114 COMPOSITIONS ET PROCEDES DE TRAITEMENT DES MALADIES DE L'ONGLE (COMPOSITIONS AND METHODS FOR TREATING DISEASES OF THE NAIL) See Plans and Pricing
Australia 5852400 See Plans and Pricing
Portugal 1205559 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Moodys
Merck
Colorcon
Express Scripts

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.