Details for New Drug Application (NDA): 207356

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NDA 207356 describes ARIKAYCE KIT, which is a drug marketed by Insmed Inc and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the ARIKAYCE KIT profile page.

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.

Summary for 207356

Tradename:	ARIKAYCE KIT
Applicant:	Insmed Inc
Ingredient:	amikacin sulfate
Patents:	13

Pharmacology for NDA: 207356

Medical Subject Heading (MeSH) Categories for 207356

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 207356

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356	NDA	Insmed Incorporated	71558-590	71558-590-28	28 VIAL in 1 CARTON (71558-590-28) / 8.4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, LIPOSOMAL;INHALATION			Strength	EQ 590MG BASE/8.4ML
Approval Date:	Sep 28, 2018	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 28, 2030
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Sep 28, 2025
Regulatory Exclusivity Use:	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
Patent:	⤷ Sign Up	Patent Expiration:	May 15, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

Expired US Patents for NDA 207356

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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

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