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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amikacin sulfate has two hundred and seven 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:	207
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:	7,305
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
Hospira	AMIKACIN SULFATE	amikacin sulfate	INJECTABLE;INJECTION	063350-001	Jul 30, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	⤷ Sign Up	⤷ Sign Up
>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
Israel	216401	תכשיר אנטי-זיהומי המכיל אמיקצין ותערובת שומנים ושיטה להכנתו (Antiinfective formulation comprising amikacin and a lipid mixture and method of its preparation)	⤷ Sign Up
Portugal	2852391		⤷ Sign Up
Japan	2015025016	抗感染剤の徐放 (SUSTAINED RELEASE OF ANTIINFECTIVES)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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