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Kimyrsa

(Single-Dose IV Oritavancin Diphosphate)

Small molecule

MMelinta Therapeutics, Inc.

0

Indications

5

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

4

Patents

Clinical

Trials by Indication[1]

Vancomycin2 trials

Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT01252732·1,019 enrolled

Oritavancin Versus IV Vancomycin for the Treatment of Participants With Acute Bacterial Skin and Skin Structure Infection (SOLO I)

Completed·MMelinta Therapeutics, Inc.·Phase 3·NCT01252719·968 enrolled

Interaction1 trial

Drug-Drug Interaction Potential of Orbactiv (Oritavancin) Co-Administered With Warfarin in Healthy Subjects

Completed·MMelinta Therapeutics, Inc.·Phase 1·NCT02340988·36 enrolled

Cardiac1 trial

A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants

Completed·MMelinta Therapeutics, Inc.·Phase 1·NCT01762839·150 enrolled

Infusion1 trial

Open Label Study Evaluating the Effects of a Single Oritavancin Infusion on Cytochrome P450 in Healthy Volunteers

Completed·MMelinta Therapeutics, Inc.·Phase 1·NCT01784536·16 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 6, 2014

ORBACTIV

NDA NDA206334

Mar 12, 2021

KIMYRSA

NDA NDA214155

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Single-Dose IV Oritavancin Diphosphate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Single-Dose IV Oritavancin Diphosphate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA214155). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Kimyrsa. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Melinta Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: MMelinta Therapeutics, Inc.

Patent Landscape[4]

Patent Cliff

Aug 29, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8420592Aug 29, 2029

12514899Aug 29, 2029

9682061Apr 26, 2030

9649352Jul 16, 2035

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