Wednesday, July 8, 2026

Drug profile · INN

bivalirudin

bivalirudin (BIVALIRUDIN ARX) is a thrombin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

FDA: approved EMA: withdrawn TGA: approved Blood and blood forming organs (B01) B01AE06
US status approved
Patents linked 3
Pipeline programs 1
News articles 0
Drug details — bivalirudin
US status
approved
Class
Blood and blood forming organs (B01)
Route
INJECTION
Patents
3
Programs
1
Data quality
0.89

Quick answer

bivalirudin (BIVALIRUDIN ARX) is a thrombin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

Key facts

INN bivalirudin
Brand BIVALIRUDIN ARX
Mechanism Thrombin inhibitor
Target Prothrombin
Therapeutic class Blood and blood forming organs (B01)
Route INJECTION
Formulation INJECTABLE
ATC code B01AE06

Mechanism of action

Thrombin inhibitor

Primary target: Prothrombin

Approval history

Authority Status Date
FDA approved
EMA withdrawn
TGA approved

Pipeline programs

  1. Bivalirudin Unknown · First People's Hospital · ST-segment Elevation Myocardial Infarction (STEMI)

Related & competitor drugs

  1. apixaban Blood and blood forming organs (B01)
  2. argatroban Thrombin inhibitor
  3. berotralstat Blood and blood forming organs (B06)
  4. c1 inhibitor (human) Blood and blood forming organs (B06)
  5. clopidogrel Blood and blood forming organs (B01)
  6. dabigatran etexilate Blood and blood forming organs (B01)
  1. US 11992514

    Ready-to-use bivalirudin compositions

    Expires Mon May 23 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11918622

    Ready-to-use bivalirudin compositions

    Expires Mon Feb 29 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11903993

    Ready-to-use bivalirudin compositions

    Expires Mon Feb 15 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is bivalirudin?

bivalirudin (BIVALIRUDIN ARX) is a thrombin inhibitor. Associated with Lacuna Pharma Pty Ltd. Route of administration: injection. Current US regulatory status: approved.

What is the brand name for bivalirudin?

BIVALIRUDIN ARX is a marketed brand name for bivalirudin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of bivalirudin?

bivalirudin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.