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Last Updated: May 7, 2024

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, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, Sagent Pharms Inc, Apothecon, and Insmed Inc, and is included in twenty-six 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. Six suppliers are listed for this compound.

Summary for amikacin sulfate

International Patents:	204
US Patents:	12
Tradenames:	5
Applicants:	11
NDAs:	26
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	6
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

Anatomical Therapeutic Chemical (ATC) Classes for amikacin sulfate

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
Apothecon	AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	050618-002	Nov 30, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meitheal	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	064045-002	Sep 28, 1993	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
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
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063274-001	May 18, 1992		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	064099-001	Jun 20, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063315-001	Apr 11, 1994	AP	RX	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
Japan	2014098047	HIGH SPEED DELIVERY OF DRUG PREPARATION WITH LIPID AND TREATMENT METHOD THEREOF	⤷ Try a Trial
Portugal	1909759		⤷ Try a Trial
Hong Kong	1202812	治療肺部感染的系統 (SYSTEMS FOR TREATING PULMONARY INFECTIONS)	⤷ Try a Trial
Japan	2017193589	肺感染症を処置するためのシステム (SYSTEM FOR TREATING PULMONARY INFECTION)	⤷ Try a Trial
Japan	2021143187	非結核性抗酸菌肺感染症を治療するための方法 (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS)	⤷ Try a Trial
European Patent Office	2007398	VITESSES D'ADMINISTRATION ÉLEVÉES POUR PRÉPARATIONS MÉDICAMENTEUSES LIPIDIQUES ET MÉTHODES DE TRAITEMENT ASSOCIÉES (HIGH DELIVERY RATES FOR LIPID BASED DRUG FORMULATIONS, AND METHODS OF TREATMENT THEREOF)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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