Home / Generic availability / Bivalirudin
When will generic Bivalirudin be available?
Based on the patents and exclusivity the FDA lists today, generic bivalirudin cannot be marketed in the United States before 2039-05-20, when the last listed protection expires.
Patents listed with the FDA
8 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 7582727 | 2028-07-27 | drug product | ANGIOMAX |
| 7598343 | 2028-07-27 | drug product | ANGIOMAX |
| 7582727*PED | 2029-01-27 | method of use | ANGIOMAX |
| 7598343*PED | 2029-01-27 | method of use | ANGIOMAX |
| 11903993 | 2039-05-20 | method of use | ANGIOMAX RTU |
| 11918622 | 2039-05-20 | method of use | ANGIOMAX RTU |
| 11992514 | 2039-05-20 | drug product | ANGIOMAX RTU |
| 12472224 | 2039-05-20 | drug product | ANGIOMAX RTU |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| ANGIOMAX | Brand (NDA) | SANDOZ INC | 2000-12-15 | reference listed drug, reference standard |
| BIVALIRUDIN | Generic (ANDA) | FRESENIUS KABI USA LLC | 2016-10-28 | |
| BIVALIRUDIN | Generic (ANDA) | HOSPIRA INC | 2015-07-14 | |
| BIVALIRUDIN | Generic (ANDA) | HOSPIRA INC | 2015-07-14 | |
| BIVALIRUDIN | Generic (ANDA) | MEITHEAL PHARMACEUTICALS INC | 2018-07-16 | |
| BIVALIRUDIN | Generic (ANDA) | DR REDDYS LABORATORIES LTD | 2017-05-26 | |
| BIVALIRUDIN | Generic (ANDA) | MYLAN INSTITUTIONAL LLC | 2018-06-01 | |
| BIVALIRUDIN | Generic (ANDA) | APOTEX INC | 2017-07-06 | |
| BIVALIRUDIN | Generic (ANDA) | EUGIA PHARMA SPECIALITIES LTD | 2018-07-27 | |
| BIVALIRUDIN | Generic (ANDA) | ACCORD HEALTHCARE INC | 2017-11-22 | |
| BIVALIRUDIN IN 0.9% SODIUM CHLORIDE | Brand (NDA) | BAXTER HEALTHCARE CORP | 2017-12-21 | reference listed drug |
| BIVALIRUDIN | Generic (ANDA) | HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | 2019-10-23 | |
| ANGIOMAX RTU | Brand (NDA) | MAIA PHARMACEUTICALS INC | 2019-07-25 | reference listed drug, reference standard |
| BIVALIRUDIN | Generic (ANDA) | HAINAN POLY PHARM CO LTD | 2021-05-28 |
What a generic Bivalirudin would have to match
Forms and strengths
For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg bivalirudin trifluoroacetate*. *The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.9 to 2.6 equivalents. For injection: 250 mg of bivalirudin as a lyophilized powder in a single-dose vial for reconstitution ( 3 )
How it is supplied
16.1 How Supplied Bivalirudin for Injection is supplied as follows: NDC Bivalirudin for Injection Package Factor 83634-400-10 250 mg Single-Dose Vial 10 vials per carton Bivalirudin for Injection is a sterile, lyophilized powder in single-dose, glass vials. Each vial contains 250 mg of bivalirudin equivalent to an average of 275 mg of bivalirudin trifluoroacetate*. *The range of bivalirudin trifluoroacetate is 270 to 280 mg based on a range of trifluoroacetic acid composition of 1.9 to 2.6 equivalents. 16.2 Storage Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion....
Storage
16.2 Storage Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex.
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-08-20.
Recalls involving Bivalirudin
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Accord Healthcare, Inc. | NC | Class II | 2023-07-03 | Presence of Particulate Matter: Particulate matter identified as fiber |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Degarelixprotection runs to February 2029
- Desmopressinprotection runs to May 2029
- Triptorelinprotection runs to June 2029
- Afamelanotideprotection runs to January 2033
- Bremelanotideprotection runs to November 2033
Frequently asked questions
When will generic Bivalirudin be available?
Based on the patents and exclusivity the FDA lists today, generic bivalirudin cannot be marketed in the United States before 2039-05-20, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-11-01. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.
Related data
- Bivalirudin clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book