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Last Updated: January 27, 2023

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, 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-five patent family members in twenty-nine countries.

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

Summary for amikacin sulfate
International Patents:195
US Patents:12
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 118
Clinical Trials: 5
Patent Applications: 5,756
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

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
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062562-002 Sep 20, 1984 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 See Plans and Pricing
Hospira AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063283-001 Oct 31, 1994 DISCN No No See Plans and Pricing See Plans and Pricing 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
European Patent Office 2649988 Libération prolongée d'aminoglycosides anti-infectieux (Sustained release of antiinfective aminoglycosides) See Plans and Pricing
Japan 6980745 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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.