Amikacin Sulfate Patent Expiration

Amikacin Sulfate is used for treating Mycobacterium Avium Complex (MAC) lung disease in adults as part of a combination drug regimen. It was first introduced by Apothecon Inc Div Bristol Myers Squibb in its drug Amikin on Approved Prior to Jan 1, 1982. Other drugs containing Amikacin Sulfate are Arikayce Kit, Amikin In Sodium Chloride 0.9% In Plastic Container. 11 different companies have introduced drugs containing Amikacin Sulfate.


Amikacin Sulfate Patents

Given below is the list of patents protecting Amikacin Sulfate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Arikayce Kit US10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections May 15, 2035 Insmed Inc
Arikayce Kit US10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections May 15, 2035 Insmed Inc
Arikayce Kit US11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections May 15, 2035 Insmed Inc
Arikayce Kit US12016873 Methods for treating pulmonary non-tuberculous mycobacterial infections May 15, 2035 Insmed Inc
Arikayce Kit US9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections May 15, 2035 Insmed Inc
Arikayce Kit US9566234 Systems for treating pulmonary infections Jan 18, 2034 Insmed Inc
Arikayce Kit US8226975 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Aug 15, 2028 Insmed Inc
Arikayce Kit US8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Dec 05, 2026 Insmed Inc
Arikayce Kit US8642075 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Dec 05, 2026 Insmed Inc
Arikayce Kit US8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof Dec 05, 2026 Insmed Inc
Arikayce Kit US7718189 Sustained release of antiinfectives Jun 06, 2025 Insmed Inc
Arikayce Kit US8802137 Sustained release of antiinfectives Apr 08, 2024

(Expired)

Insmed Inc
Arikayce Kit US9827317 Sustained release of antiinfectives Apr 08, 2024

(Expired)

Insmed Inc



Amikacin Sulfate's Family Patents

Family Patents

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Amikacin Sulfate Generic API Manufacturers

Several generic applications have been filed for Amikacin Sulfate. The first generic version for Amikacin Sulfate was by Apothecon Inc Div Bristol Myers Squibb and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Qilu Pharmaceutical Co Ltd and was approved on Mar 19, 2024.

Given below is the list of companies who have filed for Amikacin Sulfate generic, along with the locations of their manufacturing plants worldwide.


1. ABBOTT

Abbott Laboratories has filed for 1 generic for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Abbott.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Discontinued INJECTION N/A Nov 30, 1994


Manufacturing Plant Locations
New

Abbott's manufacturing plants are situated in 7 countries - United States, Netherlands, United Kingdom, Norway, Germany, France, Ireland. Given below are the details of these plant locations as well as the firm names of Abbott as present at those locations.

Country City Firm Name
United States
Scarborough Abbott Diagnostics Scarborough, Inc.
Alameda Abbott Diabetes Care, Inc.
Plymouth Abbott
Clearwater ABBOTT BLACKSTONE CO.
Barceloneta Abbott Healthcare (Puerto Rico) Ltd.
Barceloneta Abbott Diagnostics International, Ltd.
Netherlands
Olst Abbott Biologicals BV
United Kingdom
Witney ABBOTT DIABETES CARE LIMITED
Norway
Oslo Abbott Diagnostics Technologies AS
Germany
Wiesbaden Abbott GmbH
France
Chatillon Sur Chalaronne Abbott Healthcare SAS
Ireland
Co. Longford Abbott Ireland Diagnostics Division
Donegal ABBOTT IRELAND DIABETES CARE
Cootehill ABBOTT IRELAND LIMITED
Sligo Abbott Ireland
Sligo Abbott Ireland Limited





2. APOTHECON

Apothecon Inc Div Bristol Myers Squibb has filed for 2 different strengths of generic version for Amikacin Sulfate. All of these versions come by the name AMIKIN. Given below are the details of the strengths of this generic introduced by Apothecon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 50MG BASE/ML

injectable Discontinued INJECTION N/A Sep 20, 1984
EQ 250MG BASE/ML

injectable Discontinued INJECTION N/A Sep 20, 1984


Manufacturing Plant Locations
New

Apothecon's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Apothecon as present at those locations.

Country City Firm Name
India
Taluka Padra, Vadodara Apothecon Pharmaceuticals Private Limited





3. AVET LIFESCIENCES

Avet Lifesciences Ltd has filed for 1 generic for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Avet Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

(reference standard)

injectable Prescription INJECTION AP Dec 12, 2013





4. FRESENIUS KABI USA

Fresenius Kabi Usa Llc has filed for 2 different strengths of generic version for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Prescription INJECTION AP Dec 9, 2015
EQ 50MG BASE/ML

injectable Discontinued INJECTION N/A Dec 9, 2015


Manufacturing Plant Locations
New

Fresenius Kabi Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Fresenius Kabi Usa as present at those locations.

Country City Firm Name
United States
Skokie Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC
Bensenville Fresenius Kabi USA LLC (FK USA)
North Andover Fresenius Kabi USA, LLC





5. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Prescription INJECTION AP Apr 11, 1994
EQ 50MG BASE/ML

(reference standard)

injectable Prescription INJECTION N/A Apr 11, 1994


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





6. HOSPIRA

Hospira Worldwide, Inc has filed for 4 different strengths of generic version for Amikacin Sulfate. Out of these eq 500mg base/100ml version comes by the name AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Discontinued INJECTION N/A Jun 26, 1995
EQ 50MG BASE/ML

injectable Discontinued INJECTION N/A Nov 30, 1994
EQ 62.5MG BASE/ML

injectable Discontinued INJECTION N/A Oct 31, 1994
EQ 500MG BASE/100ML

injectable Discontinued INJECTION N/A Apr 2, 1997


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Morgan Hill Hospira Inc
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Rocky Mount Hospira, Inc.
Mcpherson Hospira, Inc., A Pfizer Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





7. IGI LABS INC

Igi Laboratories Inc has filed for 2 different strengths of generic version for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Igi Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Discontinued INJECTION N/A Dec 14, 1995
EQ 50MG BASE/ML

injectable Discontinued INJECTION N/A Dec 14, 1995





8. MEITHEAL

Meitheal Pharmaceuticals Inc has filed for 2 different strengths of generic version for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Meitheal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Prescription INJECTION AP Sep 28, 1993
EQ 50MG BASE/ML

injectable Discontinued INJECTION N/A Sep 28, 1993





9. QILU

Qilu Pharmaceutical Co Ltd has filed for 1 generic for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Qilu.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Prescription INJECTION AP Mar 19, 2024


Manufacturing Plant Locations
New

Qilu's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Qilu as present at those locations.

Country City Firm Name
China
Jinan Qilu Pharmaceutical Co., Ltd.
Dezhou Qilu SYNVA Pharmaceutical Co. Ltd
Hulunbeier Qilu Pharmaceutical Hulun Buir Branch
Jinan Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
Jinan Qilu Antibiotics Pharmaceutical Co. , Ltd.
Haikou Qilu Pharmaceutical (Hainan) Co. Ltd.
Hohhot Qilu Pharmaceutical (Inner Mongolia) Co., Ltd.





10. SAGENT PHARMS INC

Sagent Pharmaceuticals Inc has filed for 1 generic for Amikacin Sulfate. Given below are the details of the strengths of this generic introduced by Sagent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 250MG BASE/ML

injectable Prescription INJECTION AP May 12, 2016