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Miebo

(Perfluorohexyloctane)

Small molecule

BBausch Health Americas, Inc.

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

10

Patents

Clinical

Trials by Indication[1]

Dry Eye Disease1 trial

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

Completed·BBausch & Lomb Incorporated·Phase 2·NCT07128628·443 enrolled

Unspecified1 trial

A Study to Evaluate Concomitant Perfluorohexyloctane Use With Contact Lens Wear

Completed·BBausch & Lomb Incorporated·Phase 4·NCT07054606·104 enrolled

Regulatory

FDA Approval Timeline[3]

May 18, 2023

MIEBO

NDA NDA216675

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Perfluorohexyloctane. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Perfluorohexyloctane compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA216675). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Miebo. 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

Sep 12, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12005033Sep 12, 2033

10449164Sep 12, 2033

10369117Sep 12, 2033

10058615Sep 12, 2033

10576154Oct 1, 2035

5 more patents

12128010Sep 29, 2036

10682315Sep 29, 2036

11357738Sep 29, 2036

RE50060Jun 21, 2037

10507132Jun 21, 2037

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