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Last Updated: April 16, 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

Sponsor	Phase
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2
Insmed Incorporated	Phase 2

See all amikacin sulfate clinical trials

Pharmacology for amikacin sulfate

Drug Class	Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for amikacin sulfate

Anti-Bacterial Agents

US Patents and Regulatory Information for amikacin sulfate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Meitheal	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	064045-001	Sep 28, 1993		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063264-001	Nov 30, 1994		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062311-002	Approved Prior to Jan 1, 1982		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

Expired US Patents for amikacin sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	⤷ Try a Trial	⤷ Try a Trial
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for amikacin sulfate

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Country	Patent Number	Title	Estimated Expiration
Mexico	PA05004580	LIBERACION SOSTENIDA DE ANTI - INFECCIOSOS. (SUSTAINED RELEASE OF ANTIINFECTIVES.)	⤷ Try a Trial
Russian Federation	2008102651	ЗАМЕДЛЕННОЕ ВЫСВОБОЖДЕНИЕ ПРОТИВОИНФЕКЦИОННЫХ АГЕНТОВ	⤷ Try a Trial
New Zealand	726256	Methods for treating pulmonary non-tuberculous mycobacterial infections	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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