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Last Updated: May 27, 2022

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 eleven patents protecting this drug.

This drug has one hundred and eighty-six 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. Five 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 TEVA PHARMS USA on September 28th, 1993.

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Summary for ARIKAYCE KIT
International Patents:186
US Patents:11
Applicants:1
NDAs:1
Clinical Trials: 7
Formulation / Manufacturing:see details
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

US Patents and Regulatory Information for ARIKAYCE KIT

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

Patents protecting ARIKAYCE KIT

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

Sustained release of antiinfectives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Systems for treating pulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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 2021143187 非結核性抗酸菌肺感染症を治療するための方法 (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) See Plans and Pricing
Japan 5415759 See Plans and Pricing
Japan 6980745 See Plans and Pricing
Portugal 3142643 See Plans and Pricing
Japan 5118302 See Plans and Pricing
China 103263387 Sustained release of antiinfectives See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Harvard Business School
Express Scripts
McKesson
AstraZeneca

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