Amikacin sulfate - Generic Drug Details

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, Qilu, Sagent Pharms Inc, Apothecon, and Insmed Inc, and is included in twenty-six NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has two hundred and eight 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:	208
US Patents:	13
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
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
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	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

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063274-001	May 18, 1992		DISCN	No	No
Hospira	AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	amikacin sulfate	INJECTABLE;INJECTION	064146-001	Apr 2, 1997		DISCN	No	No
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes
Abbott	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063266-001	Oct 31, 1994		DISCN	No	No
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes			Y
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	062562-002	Sep 20, 1984		DISCN	No	No

Expired US Patents for amikacin sulfate

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
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018

International Patents for amikacin sulfate

Country	Patent Number	Title	Estimated Expiration
Slovenia	2852391
Croatia	P20220158
Poland	1909759
South Korea	101437338
New Zealand	726256	Methods for treating pulmonary non-tuberculous mycobacterial infections
Portugal	2363114
European Patent Office	3184100	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)