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.

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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 Rtu US12472224 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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Clinical Trials

Recent Clinical Trials on Bivalirudin:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation Sydney Local Health District NA RECRUITING
(May 1, 2026)
PHASE2


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 Hainan Poly Pharm Co Ltd 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.