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Last Updated: March 19, 2024

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, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Sagent Pharms Inc, 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 two hundred and 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:204
US Patents:12
Tradenames:5
Applicants:10
NDAs:25
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 120
Clinical Trials: 5
Patent Applications: 5
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
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 050495-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063263-001 Nov 30, 1994 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Japan 2018199727 肺感染症を処置するためのシステム (SYSTEM FOR TREATING PULMONARY INFECTION) ⤷  Try a Trial
Russian Federation 2014151554 СИСТЕМЫ ДЛЯ ЛЕЧЕНИЯ ЛЕГОЧНЫХ ИНФЕКЦИЙ ⤷  Try a Trial
European Patent Office 2823820 Liposomes contenant un aminoglycoside pour le traitement d'infections pulmonaires (Liposomes comprising an aminoglycoside for the treatment of pulmonary infections) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.