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Last Updated: May 13, 2024

AMIKACIN SULFATE - Generic Drug Details

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What are the generic 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 twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has two hundred and six 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:	206
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

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
Apothecon	AMIKIN	amikacin sulfate	INJECTABLE;INJECTION	050495-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063313-001	Apr 11, 1994		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sagent Pharms Inc	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	203323-001	May 12, 2016	AP	RX	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
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063350-001	Jul 30, 1993		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
European Patent Office	3718532	COMPOSITIONS A BASE DE LIPIDE D'ANTI-INFECTIEUX POUR TRAITER DES INFECTIONS PULMONAIRES (LIPID-BASED COMPOSITIONS OF ANTIINFECTIVES FOR TREATING PULMONARY INFECTIONS)	⤷ Try a Trial
Israel	168279	שימוש של הרכב ליפוזומלי ואמינוגליקוסיד להכנת תרופה לטיפול או שיפור בזיהום (Use of liposomal aminoglycoside formulation in the manufacture of a medicament for treating or ameliorating pulmonary infection)	⤷ Try a Trial
Poland	3142643		⤷ Try a Trial
Japan	2019052170	徐放性抗感染剤 (SUSTAINED RELEASE ANTI-INFECTIVE AGENT)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007117509		⤷ Try a Trial
Japan	5800865		⤷ Try a Trial
Japan	2017515913	非結核性抗酸菌肺感染症を治療するための方法	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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