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Flector

(Diclofenac epolamine)

Small molecule

IIBSA Institut Biochimique SA

0

Indications

3

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

2

Patents

Clinical

Trials by Indication[1]

Diclofenac2 trials

Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

Completed·NNorthwestern University·Phase 1·NCT01380353·30 enrolled

Evaluation of Bioavailability of Diclofenac Dermal Products

Completed·UUniversity of Maryland, Baltimore·Phase 1·NCT03145259·12 enrolled

Sprain1 trial

Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain

Completed·AActavis Inc.·Phase 3·NCT02324270·658 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 31, 2007

FLECTOR

NDA NDA021234

Dec 19, 2018

LICART

NDA NDA206976

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Diclofenac epolamine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Diclofenac epolamine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA206976). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Flector. U.S. Food & Drug Administration.
[5]
SEC EDGAR — IBSA Institut Biochimique SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: IIBSA Institut Biochimique SA

Patent Landscape[4]

Patent Cliff

Feb 20, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11351133Feb 20, 2035

11344520Feb 20, 2035

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