Drug
Who makes bivalirudin?
13 companies list bivalirudin as a human prescription drug. Forms: injection; injection, powder, lyophilized, for solution; injection, powder, lyophilized, for suspension; injection, solution. Routes: intracavernous, intravenous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing bivalirudin
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Dr. Reddy's Laboratories LimitedIndia | injection | ANDAANDA201577 | 1 | 15 |
| Fresenius Kabi USA, LLCUnited States | injection, powder, lyophilized, for solution | ANDAANDA090189 | 1 | 6 |
| Par Health USA, LLCIndia | injection, solution | NDANDA211215 | 1 | 5 |
| Sandoz Industrial Products S.AAustria | injection, powder, lyophilized, for solution | NDA AUTHORIZED GENERICNDA020873 | 1 | 5 |
| ACCORD HEALTHCARE LIMITEDUnited Kingdom | injection, powder, lyophilized, for solution | ANDAANDA206551 | 1 | 2 |
| Civica, Inc. dba CivicaRxUnited States | injection, powder, lyophilized, for solution | NDA AUTHORIZED GENERICNDA020873 | 1 | 1 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd.China | injection, powder, lyophilized, for solution | ANDAANDA210031 | 1 | 1 |
| Slate Run Pharmaceuticals, LLCUnited States | injection, powder, lyophilized, for suspension | ANDAANDA213078 | 1 | 1 |
| Avenacy, Inc. | injection, powder, lyophilized, for solution | ANDAANDA210031 | 1 | 0 |
| Eugia US LLC | injection, powder, lyophilized, for solution | ANDAANDA205962 | 1 | 0 |
| MAIA Pharmaceuticals, Inc. | injection, solution | NDANDA211215 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | injection, powder, lyophilized, for solution | ANDAANDA091602 | 1 | 0 |
| Mylan Institutional Inc. | injection, powder, lyophilized, for solution | ANDAANDA202471 | 1 | 0 |
Bulk ingredient listings
- Sinopep-Allsino Biopharmaceutical Co., Ltd.China · 2 NDC
- Ambiopharm, Inc.United States · 1 NDC
- Bachem AGSwitzerland · 1 NDC
- Chengdu Shengnuo Biopharm Co., Ltd.China · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.China · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
Orange Book patents
8 unexpired patents list bivalirudin as the active ingredient, expiring between Jul 2028 and May 2039. Application holders: MAIA PHARMACEUTICALS INC, SANDOZ INC.
Enquiry
Common questions
- Who makes bivalirudin?
- 13 companies list bivalirudin as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddy's Laboratories Limited, Fresenius Kabi USA, LLC, Par Health USA, LLC, Sandoz Industrial Products S.A, ACCORD HEALTHCARE LIMITED. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic bivalirudin?
- 9 companies list bivalirudin under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies bivalirudin active ingredient?
- 8 companies list bivalirudin as a bulk ingredient, including Sinopep-Allsino Biopharmaceutical Co., Ltd., Ambiopharm, Inc., Bachem AG, Chengdu Shengnuo Biopharm Co., Ltd..