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. 2 generic applications already hold tentative FDA approval, meaning the FDA has judged them acceptable and they are waiting on these dates.
Generics already cleared and waiting
A tentative approval means the FDA has already judged the generic to meet its standards but cannot allow marketing yet.
- MYLAN LABS LTD tentative approval 2017, application ANDA091468
- PLIVA HRVATSKA DOO tentative approval 2016, application ANDA091206
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 |
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. 2 generic applications already hold tentative FDA approval, meaning the FDA has judged them acceptable and they are waiting on these dates.
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 2026-09-23. 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.