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Last Updated: December 6, 2022

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, Hikma, Hospira, Igi Labs Inc, Sagent Pharms Inc, Teva Pharms Usa, Apothecon, and Insmed Inc, and is included in twenty-five NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for amikacin sulfate
International Patents:194
US Patents:12
Tradenames:5
Applicants:10
NDAs:25
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 113
Clinical Trials: 5
Patent Applications: 7,800
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
Alphacait, LLCPhase 2
Insmed IncorporatedPhase 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
Sagent Pharms Inc AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 203323-001 May 12, 2016 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Igi Labs Inc AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063167-001 Dec 14, 1995 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for amikacin sulfate

Country Patent Number Title Estimated Expiration
Poland 1962805 See Plans and Pricing
Spain 2820226 See Plans and Pricing
Canada 2631872 COMPOSITIONS A BASE DE LIPIDE D'ANTI-INFECTIEUX POUR TRAITERDES INFECTIONS PULMONAIRES ET PROCEDES D'UTILISATION DE CELLES-CI (LIPID-BASED COMPOSITIONS OF ANTIINFECTIVES FOR TREATING PULMONARY INFECTIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Baxter

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