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FDA Orange Book · active-ingredient family

Efinaconazole

Efinaconazole is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:JUBLIA · NDA 203567

1

Brand (NDA)

7

Generics (ANDA)

18

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution

ProductApplicantApplicationTEApproved
JUBLIARLDBAUSCHNDA 203567ABJun 06, 2014

Generic (ANDA) products (7)

ProductApplicantApplicationTEApproved
EFINACONAZOLEALEMBICANDA 212027ABFeb 23, 2026
EFINACONAZOLEZYDUS LIFESCIENCESANDA 212178—Jul 15, 2022
EFINACONAZOLELUPINANDA 212169—Mar 02, 2022
EFINACONAZOLENIVAGEN PHARMS INCANDA 211969ABJun 21, 2021
EFINACONAZOLEAUROBINDO PHARMA LTDANDA 212066—Mar 29, 2021
EFINACONAZOLEPADAGIS USANDA 211851—Dec 16, 2020
EFINACONAZOLETEVA PHARMS USAANDA 211827ABDec 16, 2020

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7214506Feb 22, 20264 mo ago
U-281
9566272Jan 03, 2028in 1 yr 7 mo
U-1969
9877955Jan 03, 2028in 1 yr 7 mo
U-1969
10512640Jan 03, 2028in 1 yr 7 mo
U-1969
11213519Jan 03, 2028in 1 yr 7 mo
U-2720
11872218Jan 03, 2028in 1 yr 7 mo
U-1969
10828369Jan 03, 2028in 1 yr 7 mo
Product
8039494Jul 08, 2030in 4 yr 1 mo
U-281
9861698Jul 08, 2030in 4 yr 1 mo
Product
10105444Jul 08, 2030in 4 yr 1 mo
Product
8486978Oct 24, 2030in 4 yr 5 mo
Product
9302009Oct 24, 2030in 4 yr 5 mo
Product
10342875Oct 02, 2034in 8 yr 5 mo
ProductU-2720
11654139Oct 02, 2034in 8 yr 5 mo
U-1969
10828293Oct 02, 2034in 8 yr 5 mo
U-2720
10864274Oct 02, 2034in 8 yr 5 mo
U-2720
9662394Oct 02, 2034in 8 yr 5 mo
Product
10478601Apr 25, 2035in 9 yr
ProductU-2721

Efinaconazole — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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