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Last Updated: November 7, 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
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 amikacin sulfate INJECTABLE;INJECTION 062311-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 064045-002 Sep 28, 1993 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063313-001 Apr 11, 1994 RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Igi Labs Inc AMIKACIN SULFATE amikacin sulfate INJECTABLE;INJECTION 063167-001 Dec 14, 1995 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apothecon AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER amikacin sulfate INJECTABLE;INJECTION 050618-002 Nov 30, 1987 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
Japan 2023021248 肺感染症を処置するためのシステム ⤷  Sign Up
Spain 2539591 ⤷  Sign Up
Portugal 3142643 ⤷  Sign Up
Spain 2820226 ⤷  Sign Up
European Patent Office 3766501 MÉTHODES DE TRAITEMENT D'INFECTIONS PULMONAIRES MYCOBACTÉRIENNES NON-TUBERCULEUSES (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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