Bivalirudin

For heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis…. Sold as Angiomax, Bivalirudin In 0.9% Sodium Chloride, Angiomax Rtu. Every FDA application for this active ingredient: 3 branded and 13 generic.

As of Nov 15, 2026, FDA lists 16 applications for Bivalirudin (sold as Angiomax, Bivalirudin In 0.9% Sodium Chloride, Angiomax Rtu), first approved Dec 15, 2000, with 2 new uses approved and 0 published complete response letters.

First approved: Dec 15, 2000
Applications: 16
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $0K
First approved in the EU: Sep 20, 2004

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Angiomax	Part B	$0K	-100%	0

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

For use as an anticoagulant in patients with or at risk of heparin-induced thrombocytopenia/heparin-induced…The Medicines Company · designated Nov 2, 2005

Approvals in the EU (EMA)

First approved in the EU 45 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Angiox, new substanceThe Medicines Company UK Ltd · Sep 20, 2004 · withdrawn

Clinical Trials

9 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary SyndromesPercutaneous Coronary Intervention, High Bleeding Risk · Shenyang Northern Hospital	Phase 4	Not yet recruiting	Feb 3, 2026
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic TherapyST-segment Elevation Myocardial Infarction (STEMI) · First Affiliated Hospital Xi'an Jiaotong University	Not applicable	Not yet recruiting	Mar 6, 2025
Use of Bivalirudin for Anticoagulation in Patients With Extracorporeal Membrane OxygenationExtracorporeal Membrane Oxygenation Complication · Xiaotong Hou	Not applicable	Recruiting	Feb 23, 2024
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp SystemHeart Failure, Cardiogenic Shock · Stanford University	Phase 2	Recruiting	Oct 12, 2023
A Study on the Impact of Bivalirudin Usage During PCI for High-risk Plaques on Post-PCI Coronary Microcirculation.Coronary Microvascular Dysfunction · Peking University First Hospital	Phase 4	Recruiting	Aug 9, 2023
BivaLirudin versUS Heparin in Extracorporeal Membrane OxygenationExtracorporeal Membrane Oxygenation Complication · Sydney Local Health District	Phase 2	Recruiting	Jul 25, 2023
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension · Duke University	—	Recruiting	Feb 20, 2020
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular DysfunctionCoronary Microvascular Disease, Ischemic Heart Disease · NYU Langone Health	Not applicable	Active, not recruiting	May 25, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 15, 2000	AngiomaxNDA 20873 · New molecular entity	Sandoz	22	Marketed
Jul 14, 2015	BivalirudinANDA 90811	Hospira	4	Discontinued
Jul 14, 2015	BivalirudinANDA 90816	Hospira	0	Discontinued
Oct 28, 2016	BivalirudinANDA 90189	Fresenius Kabi USA	1	Marketed
May 26, 2017	BivalirudinANDA 201577	Dr Reddys	2	Marketed
Jul 6, 2017	BivalirudinANDA 204876	Apotex	2	Discontinued
Nov 22, 2017	BivalirudinANDA 206551	Accord Hlthcare	3	Marketed
Dec 21, 2017	Bivalirudin In 0.9% Sodium ChlorideNDA 208374 · New formulation or manufacturer	Baxter Hlthcare Corp	1	Discontinued
Jun 1, 2018	BivalirudinANDA 202471	Mylan Institutional	1	Marketed
Jul 16, 2018	BivalirudinANDA 91602	Meitheal	2	Marketed
Jul 27, 2018	BivalirudinANDA 205962	Eugia Pharma	1	Discontinued
Jul 25, 2019	Angiomax RtuNDA 211215 · New formulation or manufacturer	Maia Pharms Inc	1	Marketed
Oct 23, 2019	BivalirudinANDA 210031	Shuangcheng	0	Marketed
May 28, 2021	BivalirudinANDA 213078	Hainan Poly	0	Marketed
—	BivalirudinANDA 91206	Pliva Hrvatska Doo	0	Discontinued
—	BivalirudinANDA 91468	Mylan Labs Ltd	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA