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Last Updated: November 7, 2024

ARIKAYCE KIT Drug Patent Profile


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When do Arikayce Kit patents expire, and what generic alternatives are available?

Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has two hundred and seven patent family members in twenty-nine countries.

The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Arikayce Kit

A generic version of ARIKAYCE KIT was approved as amikacin sulfate by MEITHEAL on September 28th, 1993.

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Summary for ARIKAYCE KIT
International Patents:207
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 7
DailyMed Link:ARIKAYCE KIT at DailyMed
Drug patent expirations by year for ARIKAYCE KIT
Recent Clinical Trials for ARIKAYCE KIT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
Insmed IncorporatedPhase 3
Insmed IncorporatedPhase 2

See all ARIKAYCE KIT clinical trials

Pharmacology for ARIKAYCE KIT

US Patents and Regulatory Information for ARIKAYCE KIT

ARIKAYCE KIT is protected by thirteen US patents and two FDA Regulatory Exclusivities.

Patents protecting ARIKAYCE KIT

Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

Sustained release of antiinfectives
Patent Number: ⤷  Sign Up
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Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
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Patent Expiration: ⤷  Sign Up

Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
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Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN

Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
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Patent Expiration: ⤷  Sign Up

Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Sustained release of antiinfectives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

Systems for treating pulmonary infections
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Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Sustained release of antiinfectives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

FDA Regulatory Exclusivity protecting ARIKAYCE KIT

TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ARIKAYCE KIT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ARIKAYCE KIT

See the table below for patents covering ARIKAYCE KIT around the world.

Country Patent Number Title Estimated Expiration
Japan 2023021248 肺感染症を処置するためのシステム ⤷  Sign Up
Spain 2539591 ⤷  Sign Up
Portugal 3142643 ⤷  Sign Up
Spain 2820226 ⤷  Sign Up
European Patent Office 3766501 MÉTHODES DE TRAITEMENT D'INFECTIONS PULMONAIRES MYCOBACTÉRIENNES NON-TUBERCULEUSES (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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