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Last Updated: January 24, 2020

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ARIKAYCE KIT Drug Profile

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Which patents cover Arikayce Kit, and when can generic versions of Arikayce Kit launch?

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

This drug has one hundred and fifty-three 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.

US ANDA Litigation and Generic Entry Outlook for Arikayce Kit

A generic version of ARIKAYCE KIT was approved as amikacin sulfate by WEST-WARD PHARMS INT on January 24th, 2020.

  Start Trial

Summary for ARIKAYCE KIT
International Patents:153
US Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 4
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 2
Insmed IncorporatedPhase 3

See all ARIKAYCE KIT clinical trials

Pharmacology for ARIKAYCE KIT

US Patents and Regulatory Information for ARIKAYCE KIT

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Mallinckrodt
Baxter
McKinsey
McKesson

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