Prescription medicine
Bivalirudin First approved as Angiomax
Bivalirudin (Angiomax) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
Check it at the source: the bivalirudin FDA label on DailyMed (effective September 30, 2019, Sandoz Inc); the NDA 20873 record on Drugs@FDA; every bivalirudin label on DailyMed.
Highlights of the record
FDA label of September 30, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageBivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome.
Forms and strengths
- 250 mg
- 250 mg/5ml
Injection (powder) (lyophilized) for solution; injection (solution); injection (powder) (lyophilized) for suspension; injection.
On the market
- Earliest approval on file
- December 15, 2000 Angiomax, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first July 14, 2015; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 9 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 27, 2029 Angiomax injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest July 3, 2023
- FAERS reports
- 959 through July 30, 2026
What is bivalirudin used for?
From the label: indications and usageBivalirudin for injection is indicated for use as an anticoagulant for use in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia and heparin-induced thrombocytopenia and thrombosis syndrome. Bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS).
FDA pharmacologic class: Anti-coagulant and Direct Thrombin Inhibitor.
Source: FDA drug label (bivalirudin), Sandoz Inc, effective September 30, 2019 (SPL set ce56f806-7845-429d-a1ce-c2dbf79b22eb), via openFDA; the full label on DailyMed
Is there a generic for bivalirudin (Angiomax)?
The FDA approved the first generic bivalirudin on July 14, 2015. 11 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists bivalirudin from 9 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Angiomax injection, the last expiring on January 27, 2029; a patent listed only for Angiomax Rtu injection runs to May 20, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2000 earliest approval on file
- 2015 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has bivalirudin been recalled?
The FDA's Enforcement Report lists 1 recall naming bivalirudin since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 3, 2023 | Class II | Accord Healthcare, Inc. | Presence of Particulate Matter: Particulate matter identified as fiber. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bivalirudin label say about other medicines?
The bivalirudin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name bivalirudin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Heparin | drug interactions | DRUG INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), coadministration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant … |
| Warfarin | drug interactions | DRUG INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), coadministration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant … |
Source: FDA drug label (bivalirudin), Sandoz Inc, effective September 30, 2019 (SPL set ce56f806-7845-429d-a1ce-c2dbf79b22eb), via openFDA; the full label on DailyMed
What do FAERS reports show for bivalirudin?
The FDA Adverse Event Reporting System holds 959 reports that list bivalirudin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 152 are coded as a death and 416 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Bivalirudin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other