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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

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. There are ten 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. Five 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:10
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 207356

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, LIPOSOMAL;INHALATIONStrengthEQ 590MG BASE/8.4ML
Approval Date:Sep 28, 2018TE: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:  Start TrialPatent Expiration:May 15, 2035Product Flag?Substance Flag?Delist Request?
Patented Use:TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN

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Serving leading biopharmaceutical companies globally:

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Dow

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