Argatroban Patent Expiration

Argatroban was first introduced by Sandoz Inc in its drug Argatroban on Jun 30, 2000. Other drugs containing Argatroban are Argatroban In Sodium Chloride, Argatroban In Dextrose, Argatroban In 0.9% Sodium Chloride. 13 different companies have introduced drugs containing Argatroban.


Argatroban Patents

Given below is the list of patents protecting Argatroban, 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
Argatroban In Sodium Chloride US7589106 Alcohol free formulation of argatroban Sep 26, 2027 Cipla
Argatroban In Sodium Chloride US7687516 Alcohol free formulation of argatroban Sep 26, 2027 Cipla
Argatroban US5214052 Method for dissolving arginineamides and pharmaceutical compositions containing them Jun 30, 2014

(Expired)

Sandoz



Argatroban's Family Patents

Family Patents

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Argatroban Generic API Manufacturers

Several generic applications have been filed for Argatroban. The first generic version for Argatroban was by Endo Operations Ltd and was approved on Jun 30, 2014. And the latest generic version is by Gland Pharma Ltd and was approved on Jul 31, 2023.

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


1. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 1 generic for Argatroban. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/2.5ML (100MG/ML)

injectable Prescription INJECTION AP Jan 26, 2018





2. CAPLIN

Caplin Steriles Ltd has filed for 1 generic for Argatroban. Given below are the details of the strengths of this generic introduced by Caplin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG/50ML (1MG/ML)

injectable Prescription INJECTION AP Jan 21, 2021


Manufacturing Plant Locations
New

Caplin's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Caplin as present at those locations.

Country City Firm Name
United States
Creve Coeur Caplin, Dr David
India
Gummidipoondi Caplin Steriles Limited





3. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Argatroban. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/2.5ML (100MG/ML)

injectable Prescription INJECTION AP Jun 30, 2014





4. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 2 different strengths of generic version for Argatroban. Out of these 125mg/125ml (1mg/ml) version comes by the name ARGATROBAN IN SODIUM CHLORIDE. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
125MG/125ML (1MG/ML)

injectable Prescription INTRAVENOUS AP May 22, 2017
50MG/50ML (1MG/ML)

injectable Prescription INJECTION AP Jul 31, 2023





5. HOSPIRA

Hospira Inc has filed for 1 generic for Argatroban. Given below are the details of the strengths of this generic introduced by Hospira.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/2.5ML (100MG/ML)

(reference standard)

injectable Prescription INJECTION AP Sep 21, 2016


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
Lake Forest Hospira Inc
Clayton Hospira, Inc.
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Rocky Mount Hospira, Inc.
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





6. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Argatroban. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG/2.5ML (100MG/ML)

injectable Prescription INJECTION AP Jun 30, 2014


Manufacturing Plant Locations
New

Mylan Institutional'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 Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.