Bivalirudin Patent Expiration
Bivalirudin is Used for preventing blood clots in patients undergoing percutaneous coronary intervention (PCI). It was first introduced by Sandoz Inc
Bivalirudin Patents
Given below is the list of patents protecting Bivalirudin, 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 |
|---|---|---|---|---|
| Angiomax | US5196404 | Inhibitors of thrombin |
Dec 15, 2014
(Expired) | Sandoz |
| Angiomax |
US5196404 (Pediatric) | Inhibitors of thrombin |
Jun 15, 2015
(Expired) | Sandoz |
| Angiomax | US7582727 | Pharmaceutical formulations of bivalirudin and processes of making the same | Jul 27, 2028 | Sandoz |
| Angiomax |
US7582727 (Pediatric) | Pharmaceutical formulations of bivalirudin and processes of making the same | Jan 27, 2029 | Sandoz |
| Angiomax | US7598343 | Pharmaceutical formulations of bivalirudin and processes of making the same | Jul 27, 2028 | Sandoz |
| Angiomax |
US7598343 (Pediatric) | Pharmaceutical formulations of bivalirudin and processes of making the same | Jan 27, 2029 | Sandoz |
| Angiomax Rtu | US11903993 | Ready-to-use bivalirudin compositions | May 20, 2039 | Maia Pharms Inc |
| Angiomax Rtu | US11918622 | Ready-to-use bivalirudin compositions | May 20, 2039 | Maia Pharms Inc |
| Angiomax Rtu | US11992514 | Ready-to-use bivalirudin compositions | May 20, 2039 | Maia Pharms Inc |
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Bivalirudin Generics
Several generic applications have been filed for Bivalirudin. The first generic version for Bivalirudin was by Hospira Inc and was approved on Jul 14, 2015. And the latest generic version is by Slate Run Pharmaceuticals Llc and was approved on May 28, 2021.
Given below is the list of companies who have filed for Bivalirudin generic.
1. ACCORD HLTHCARE
Accord Healthcare Inc has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | Nov 22, 2017 |
2. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | May 26, 2017 |
3. SLATE RUN PHARMA
Slate Run Pharmaceuticals Llc has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Slate Run Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | May 28, 2021 |
4. HOSPIRA
Hospira Inc has filed for 1 generic for Bivalirudin. 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/VIAL | injectable | Discontinued | INTRAVENOUS | N/A | Jul 14, 2015 |
5. MYLAN INSTITUTIONAL
Mylan Institutional Llc has filed for 1 generic for Bivalirudin. 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/VIAL | injectable | Prescription | INTRAVENOUS | AP | Jun 1, 2018 |
6. MEITHEAL
Meitheal Pharmaceuticals Inc has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Meitheal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | Jul 16, 2018 |
7. EUGIA PHARMA
Eugia Pharma Specialities Ltd has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Eugia Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | Jul 27, 2018 |
8. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Bivalirudin. 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 |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | Oct 28, 2016 |
9. APOTEX
Apotex Inc has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Discontinued | INTRAVENOUS | N/A | Jul 6, 2017 |
10. SHUANGCHENG
Hainan Shuangcheng Pharmaceuticals Co Ltd has filed for 1 generic for Bivalirudin. Given below are the details of the strengths of this generic introduced by Shuangcheng.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 250MG/VIAL | injectable | Prescription | INTRAVENOUS | AP | Oct 23, 2019 |