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Last Updated: November 22, 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 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

SponsorPhase
Alphacait, LLCPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 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
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
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 050495-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apothecon AMIKIN amikacin sulfate INJECTABLE;INJECTION 062562-002 Sep 20, 1984 DISCN No No ⤷  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

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

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
Cyprus 1116410 ⤷  Sign Up
South Korea 20140045569 SUSTAINED RELEASE OF ANTIINFECTIVES ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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