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Last Updated: July 12, 2020

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Amikacin sulfate - Generic Drug Details

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What are the generic drug sources for amikacin sulfate and what is the scope of freedom to operate?

Amikacin sulfate is the generic ingredient in five branded drugs marketed by Abbott, Emcure Pharms Ltd, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Sagent Pharms Inc, Teva Pharms Usa, West-ward Pharms Int, Apothecon, and Insmed Inc, and is included in twenty-five NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has one hundred and sixty-one patent family members in twenty-nine countries.

There are fifteen drug master file entries for amikacin sulfate. Five suppliers are listed for this compound.

Summary for amikacin sulfate
Recent Clinical Trials for amikacin sulfate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Insmed IncorporatedPhase 2
Insmed IncorporatedPhase 1/Phase 2

See all amikacin sulfate clinical trials

Pharmacology for amikacin sulfate
Medical Subject Heading (MeSH) Categories for amikacin sulfate

US Patents and Regulatory Information for amikacin sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbott AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063266-001 Oct 31, 1994 DISCN No No   Start Trial   Start Trial   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
Fresenius Kabi Usa AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 205604-001 Dec 9, 2015 AP RX No No   Start Trial   Start Trial   Start Trial
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062311-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   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:

Medtronic
Mallinckrodt
AstraZeneca
Boehringer Ingelheim
Baxter
McKesson

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