FDA Orange Book · active-ingredient family
Efinaconazole
Efinaconazole: 1 brand, 7 generics; first approved Jun 06, 2014; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 7 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
7
Listed patents
18
Next patent expiry
Feb 22, 2026
6 mo ago
Brand (NDA) products
Originator applications
- BAUSCHNDA 2035672014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Rx AB
Generic (ANDA) products (7)
Abbreviated applications
- EFINACONAZOLEALEMBICANDA 2120272026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Rx AB - EFINACONAZOLEZYDUS LIFESCIENCESANDA 2121782022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Discontinued — - EFINACONAZOLELUPINANDA 2121692022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Discontinued — - EFINACONAZOLENIVAGEN PHARMS INCANDA 2119692021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Rx AB - EFINACONAZOLEAUROBINDO PHARMA LTDANDA 2120662021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Discontinued — - EFINACONAZOLEPADAGIS USANDA 2118512020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Discontinued — - EFINACONAZOLETEVA PHARMS USAANDA 2118272020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10% SOLUTION TOPICAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7214506 | 6 mo ago | U-281 | |
| 9566272 | in 1 yr 5 mo | U-1969 | |
| 9877955 | in 1 yr 5 mo | U-1969 | |
| 10512640 | in 1 yr 5 mo | U-1969 | |
| 11213519 | in 1 yr 5 mo | U-2720 | |
| 11872218 | in 1 yr 5 mo | U-1969 | |
| 10828369 | in 1 yr 5 mo | Product | |
| 8039494 | in 3 yr 11 mo | U-281 | |
| 9861698 | in 3 yr 11 mo | Product | |
| 10105444 | in 3 yr 11 mo | Product | |
| 8486978 | in 4 yr 3 mo | Product | |
| 9302009 | in 4 yr 3 mo | Product | |
| 10342875 | in 8 yr 3 mo | ProductU-2720 | |
| 11654139 | in 8 yr 3 mo | U-1969 | |
| 10828293 | in 8 yr 3 mo | U-2720 | |
| 10864274 | in 8 yr 3 mo | U-2720 | |
| 9662394 | in 8 yr 3 mo | Product | |
| 10478601 | in 8 yr 10 mo | ProductU-2721 |
Approval history
FDA approval span
First approval
12 yr 5 mo ago
Most recent approval
6 mo ago
Approvals span 2014–2026 across 8 FDA applications.
Brand (NDA) 113%
Generic (ANDA) 788%
Efinaconazole: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
