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Last Updated: September 22, 2021

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Amikacin sulfate - Generic Drug Details

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What are the generic sources for amikacin sulfate and what is the scope of patent protection?

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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has one hundred and seventy-nine 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
International Patents:179
US Patents:11
Tradenames:5
Applicants:10
NDAs:25
Drug Master File Entries: 15
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 103
Clinical Trials: 3
Patent Applications: 4
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in amikacin sulfate?amikacin sulfate excipients list
DailyMed Link:amikacin sulfate at DailyMed
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
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062311-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hospira AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063263-001 Nov 30, 1994 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062311-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Dow
Harvard Business School
Boehringer Ingelheim
Medtronic
Mallinckrodt
Baxter

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