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Jublia

(Efinaconazole)

Small molecule

BBausch Health Americas, Inc.

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

18

Patents

Clinical

Trials by Indication[1]

Onychomycosis1 trial

Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis

Completed·BBausch Health Americas, Inc.·Phase 4·NCT02812771·62 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

Completed·WWestern University of Health Sciences·Phase 3·NCT03168841·40 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 6, 2014

JUBLIA

NDA NDA203567

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Efinaconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Efinaconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA203567). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Jublia. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBausch Health Americas, Inc.

Patent Landscape[4]

Patent Cliff

Jan 3, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7214506Feb 22, 2026

9877955Jan 3, 2028

11872218Jan 3, 2028

11213519Jan 3, 2028

9566272Jan 3, 2028

13 more patents

10828369Jan 3, 2028

10512640Jan 3, 2028

8039494Jul 8, 2030

10105444Jul 8, 2030

9861698Jul 8, 2030

9302009Oct 24, 2030

8486978Oct 24, 2030

9662394Oct 2, 2034

10828293Oct 2, 2034

10342875Oct 2, 2034

11654139Oct 2, 2034

10864274Oct 2, 2034

10478601Apr 25, 2035

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