Bronitin Mist

(Norepinephrine Bitartrate)

ApprovedSmall molecule

LLongeveron Inc.

Bronitin Mist is one of 45 small molecule programs targeting Sepsis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

SepsisActive, not recruiting

HypotensionActive, not recruiting

SepsisApproved

Active, not recruiting

HypotensionPhase 3

Active, not recruiting

Competition

Competitive Landscape

308 competitors in Sepsis

#DrugCompanyPhaseTrials

Bronitin Mist

LLongeveron Inc.

Approved

1 2

Corlanor

Amgen

Preclinical

2 3

Simdax

Orion Corporation, Orion Pharma

Preclinical

1 4

Zemplar

Primaxin

Zyvox

Levophed

GGeneral Hospital of Ningxia Medical University

Preclinical

2 8

Epsom Salt

FFresenius Kabi Oncology Ltd.

Preclinical

1 9

Aquasol a

BBandim Health Project

Preclinical

1 10

Micardis

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Post-ApprovalRecruiting

Sex Differences

NCT05997732

Clinical

Trials by Indication[1]

Hypotension2 trials

Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy

Completed·KKasr El Aini Hospital·Phase 3·NCT05521152·31 enrolled

Determination of the ED50 and ED95 of Prophylactic Norepinephrine Infusion for Preventing Post-induction Hypotension in Elderly Patients Undergoing Major Abdominal Surgery

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT05637164·40 enrolled

Sepsis1 trial

Early Administration of Norepinephrine in Sepsis

Recruiting·TTunis University·Phase 4·NCT05836272·200 enrolled

Sex Differences1 trial

Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences

Recruiting·UUniversity of Alberta·Phase 4·NCT05997732·30 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

LEVOPHED

NDA NDA007513

Jan 1, 1982

BRONITIN MIST

NDA NDA016126

Jan 1, 1982

MEDIHALER-EPI

NDA NDA010374

Sep 15, 2022

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NDA NDA215700

Oct 6, 2022

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NDA NDA214628

Feb 28, 2025

EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NDA NDA218475

Feb 6, 2026

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NDA NDA214313

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Norepinephrine Bitartrate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Norepinephrine Bitartrate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Norepinephrine Bitartrate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214313). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bronitin Mist. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Longeveron Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LLongeveron Inc.

Patent Landscape[5]

Patent Cliff

Feb 26, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10251848Feb 26, 2035

RE49422Feb 26, 2035

RE49443Feb 26, 2035

10226436Jan 30, 2038

10568850Jan 30, 2038

8 more patents

12245996Jan 30, 2038

10159657Jan 30, 2038

11413259Jan 30, 2038

10420735Jan 30, 2038

11602508Jan 30, 2038

10888534Apr 26, 2039

12097170Mar 8, 2041

12290494Mar 8, 2041

Bronitin Mist

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Hypotension2 trials

Sepsis1 trial

Sex Differences1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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