ARIKAYCE KIT

Peak

amikacin

NDAINHALATIONSUSPENSION, LIPOSOMALPriority Review
Approved
Sep 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11

Mechanism of Action

12.1 Mechanism of Action ARIKAYCE is an antibacterial drug [see ]. 12.2 Pharmacodynamics ARIKAYCE exposure-response relationships and the time course of pharmacodynamic response are unknown. 12.3 Pharmacokinetics Sputum Concentrations Following once daily inhalation of 590 mg ARIKAYCE in…

Pharmacologic Class:

Aminoglycoside Antibacterial

Clinical Trials (5)

NCT04677569Phase 3Completed

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Started Apr 2021
425 enrolled
Mycobacterium Infections, Nontuberculous
NCT03038178Phase 2Completed

Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease

Started Oct 2016
NCT01799993Phase 3Completed

Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia

Started Apr 2013
725 enrolled
Pneumonia, Bacterial
NCT01316276Phase 3Completed

Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection

Started Oct 2012
206 enrolled
Cystic Fibrosis
NCT01315236Phase 2Completed

Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria

Started Apr 2012
90 enrolled
Mycobacterium Infections, Nontuberculous

Loss of Exclusivity

LOE Date
May 15, 2035
112 months away
Patent Expiry
May 15, 2035
Exclusivity Expiry
Sep 28, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
8632804
Dec 5, 2026
U-2416
8642075
Dec 5, 2026
Product
8679532
Dec 5, 2026
U-2415
8226975
Aug 15, 2028
Product
9566234
Jan 18, 2034
Product
U-2415