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Last Updated: March 28, 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, 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

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2
Insmed IncorporatedPhase 2

See all AMIKACIN SULFATE clinical trials

Pharmacology for AMIKACIN SULFATE
Medical Subject Heading (MeSH) Categories for AMIKACIN SULFATE

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
Apothecon AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER amikacin sulfate INJECTABLE;INJECTION 050618-001 Nov 30, 1987 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
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 050495-002 Approved Prior to Jan 1, 1982 DISCN Yes 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 062311-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for AMIKACIN SULFATE

Country Patent Number Title Estimated Expiration
Japan 2009536612 ⤷  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
Israel 216401 תכשיר אנטי-זיהומי המכיל אמיקצין ותערובת שומנים ושיטה להכנתו (Antiinfective formulation comprising amikacin and a lipid mixture and method of its preparation) ⤷  Try a Trial
Japan 2016153431 脂質を用いた薬物製剤の高速送達とその処置方法 (HIGH-SPEED DELIVERY OF LIPID BASED DRUG FORMULATIONS, AND METHODS OF TREATMENT THEREOF) ⤷  Try a Trial
Cyprus 1116410 ⤷  Try a Trial
Lithuania 2852391 ⤷  Try a Trial
Croatia P20201515 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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