amikacin sulfate

It is formulated by 5 pharmaceutical companies such as AVET LIFESCIENCES, FRESENIUS KABI USA, SAGENT PHARMS INC and others. It is marketed under 2 brand names, including AMIKACIN SULFATE, ARIKAYCE KIT. Available in 3 different strengths, such as EQ 250MG BASE/ML, EQ 50MG BASE/ML, EQ 590MG BASE/8.4ML, and administered through 2 routes including INJECTABLE;INJECTION, SUSPENSION, LIPOSOMAL;INHALATION.

Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

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Sourcing & Feasibility

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groups Licensing: 5 potential partners

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"82206","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"7dae257b5bc94bddac15","publication_number":"US7718189B2","cleaned_patent_number":"7718189","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-06","publication_date":"2010-05-18","legal_status":"Granted"} US7718189B2 Formulation 18 May, 2010 Granted 06 Jun, 2025
{"application_id":"82252","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"aef21cc9fa774f05befd","publication_number":"US8632804B2","cleaned_patent_number":"8632804","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-05","publication_date":"2014-01-21","legal_status":"Granted"} US8632804B2 21 Jan, 2014 Granted 05 Dec, 2026
{"application_id":"82253","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"aef21cc9fa774f05befd","publication_number":"US8642075B2","cleaned_patent_number":"8642075","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-05","publication_date":"2014-02-04","legal_status":"Granted"} US8642075B2 Formulation 04 Feb, 2014 Granted 05 Dec, 2026
{"application_id":"82233","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"aef21cc9fa774f05befd","publication_number":"US8679532B2","cleaned_patent_number":"8679532","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-05","publication_date":"2014-03-25","legal_status":"Granted"} US8679532B2 25 Mar, 2014 Granted 05 Dec, 2026
{"application_id":"82251","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"aef21cc9fa774f05befd","publication_number":"US8226975B2","cleaned_patent_number":"8226975","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-15","publication_date":"2012-07-24","legal_status":"Granted"} US8226975B2 Formulation 24 Jul, 2012 Granted 15 Aug, 2028
{"application_id":"82268","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"ac0b7088c2d84c3b84d8","publication_number":"US9566234B2","cleaned_patent_number":"9566234","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-01-18","publication_date":"2017-02-14","legal_status":"Granted"} US9566234B2 Formulation 14 Feb, 2017 Granted 18 Jan, 2034
{"application_id":"82309","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"0de10212a82145d18e3f","publication_number":"US10251900B2","cleaned_patent_number":"10251900","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2019-04-09","legal_status":"Granted"} US10251900B2 09 Apr, 2019 Granted 15 May, 2035
{"application_id":"82340","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"0de10212a82145d18e3f","publication_number":"US9895385B2","cleaned_patent_number":"9895385","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2018-02-20","legal_status":"Granted"} US9895385B2 20 Feb, 2018 Granted 15 May, 2035
{"application_id":"82344","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"0de10212a82145d18e3f","publication_number":"US10751355B2","cleaned_patent_number":"10751355","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2020-08-25","legal_status":"Granted"} US10751355B2 25 Aug, 2020 Granted 15 May, 2035
{"application_id":"82348","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"d19a8ba7465841bfa813","publication_number":"US11446318B2","cleaned_patent_number":"11446318","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2022-09-20","legal_status":"Granted"} US11446318B2 20 Sep, 2022 Granted 15 May, 2035
{"application_id":"124169","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"","publication_number":"US12016873B2","cleaned_patent_number":"12016873","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2024-06-25","legal_status":"Granted"} US12016873B2 25 Jun, 2024 Granted 15 May, 2035
{"application_id":"139402","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"","publication_number":"US12168021B2","cleaned_patent_number":"12168021","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2024-12-17","legal_status":"Granted"} US12168021B2 17 Dec, 2024 Granted 15 May, 2035
{"application_id":"139401","ingredient":"AMIKACIN SULFATE","trade_name":"ARIKAYCE KIT","family_id":"","publication_number":"US12168022B2","cleaned_patent_number":"12168022","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-05-15","publication_date":"2024-12-17","legal_status":"Granted"} US12168022B2 17 Dec, 2024 Granted 15 May, 2035

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

NCT ID Title Status Phase Conditions Start Date Completion Date

API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

ABBOTT Total Dosages: 1 Manufacturing Locations: 16
APOTHECON Total Dosages: 4 Manufacturing Locations: 1
AVET LIFESCIENCES Total Dosages: 1
FRESENIUS KABI USA Total Dosages: 2 Manufacturing Locations: 8
HIKMA Total Dosages: 4 Manufacturing Locations: 6
HOSPIRA Total Dosages: 1 Manufacturing Locations: 8
IGI LABS INC Total Dosages: 2
MEITHEAL Total Dosages: 2
QILU Total Dosages: 1 Manufacturing Locations: 8
SAGENT PHARMS INC Total Dosages: 1

Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.

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