Argatroban Patent Expiration
Argatroban was first introduced by Sandoz Inc
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 | US5214052 | Method for dissolving arginineamides and pharmaceutical compositions containing them |
Jun 30, 2014
(Expired) | Sandoz |
| 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 |
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Argatroban Generics
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.
1. 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |