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Naftin

(Naftifine hydrochloride foam, 3%)

Small molecule

LLegacy Health System

0

Indications

1

Total Trials

0

Active Trials

0

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

6

Patents

Clinical

Trials by Indication[1]

Safety and Efficacy1 trial

Safety and Efficacy of NAFT900 in Children With Tinea Capitis

Withdrawn·MMerz North America, Inc.·Phase 2·NCT02658292

Regulatory

FDA Approval Timeline[3]

Feb 29, 1988

NAFTIN

NDA NDA019599

Jun 18, 1990

NAFTIN

NDA NDA019356

Jun 27, 2013

NAFTIN

NDA NDA204286

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Naftifine hydrochloride foam, 3%. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naftifine hydrochloride foam, 3% compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA204286). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Naftin. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Legacy Health System company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: LLegacy Health System

Patent Landscape[4]

Patent Cliff

Jan 31, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9161914Jan 31, 2033

10729667Jan 31, 2033

8778365Jan 31, 2033

10695303Jan 31, 2033

10166206Jan 31, 2033

1 more patents

10166205Jan 31, 2033

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