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 twelve patents protecting this drug.

This drug has two hundred and 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. 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 28^th, 1993.

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Summary for ARIKAYCE KIT

International Patents:	206
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Insmed Incorporated	Phase 3
Insmed Incorporated	Phase 2

See all ARIKAYCE KIT clinical trials

Pharmacology for ARIKAYCE KIT

Drug Class	Aminoglycoside Antibacterial

US Patents and Regulatory Information for ARIKAYCE KIT

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

Patents protecting ARIKAYCE KIT

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

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Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

Sustained release of antiinfectives
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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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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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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 AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN

Systems for treating pulmonary infections
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Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN 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
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GENERATING ANTIBIOTIC INCENTIVES NOW
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Glossary

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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
>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

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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.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3142643		⤷ Sign Up
South Korea	20140045569	SUSTAINED RELEASE OF ANTIINFECTIVES	⤷ Sign Up
Canada	2614764	SUBSTANCES ANTI-INFECTIEUSES A LIBERATION LENTE (SUSTAINED RELEASE OF ANTIINFECTIVES)	⤷ Sign Up
Japan	2023033417	非結核性抗酸菌肺感染症を治療するための方法	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration