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Bivalirudin Patent Expiration

Bivalirudin is Used for preventing blood clots in patients undergoing percutaneous coronary intervention (PCI). It was first introduced by Sandoz Inc in its drug Angiomax on Dec 15, 2000. Other drugs containing Bivalirudin are Bivalirudin In 0.9% Sodium Chloride, Angiomax Rtu. 13 different companies have introduced drugs containing Bivalirudin.


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 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
Angiomax US7582727

(Pediatric)

 Pharmaceutical formulations of bivalirudin and processes of making the same Jan 27, 2029 Sandoz
Angiomax US7598343

(Pediatric)

 Pharmaceutical formulations of bivalirudin and processes of making the same Jan 27, 2029 Sandoz
Angiomax US7582727 Pharmaceutical formulations of bivalirudin and processes of making the same Jul 27, 2028 Sandoz
Angiomax US7598343 Pharmaceutical formulations of bivalirudin and processes of making the same Jul 27, 2028 Sandoz
Angiomax US5196404

(Pediatric)

 Inhibitors of thrombin Jun 15, 2015

(Expired)

 Sandoz
Angiomax US5196404 Inhibitors of thrombin Dec 15, 2014

(Expired)

 Sandoz



Bivalirudin's Family Patents

Family Patents

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Bivalirudin Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
Brantford Apotex Pharmachem Inc.
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





3. 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





4. 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


Manufacturing Plant Locations
New

Eugia Pharma'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 Eugia Pharma as present at those locations.

Country City Firm Name
India
Riico Industrial Area EUGIA Pharma Specialities Limited
Pashamylaram Eugia Pharma Specialities Limited
Medchal-Malkajgiri District EUGIA Pharma Specialities Limited





5. 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


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
Bensenville Fresenius Kabi USA LLC (FK USA)
Skokie Fresenius Kabi USA LLC
North Andover Fresenius Kabi USA, LLC
Melrose Park Fresenius Kabi USA LLC
Melrose Park Fresenius Kabi USA, LLC
Lake Zurich Fresenius Kabi USA, LLC
Wilson Fresenius Kabi USA, LLC
Grand Island Fresenius Kabi USA, LLC





6. 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


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.





7. 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





8. 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


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.





9. 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





10. 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