Data / Drug companies / Direct Thrombin Inhibitor
Direct Thrombin Inhibitor drugs: 4 drugs from 39 companies in the FDA NDC directory
Direct Thrombin Inhibitor is an FDA established pharmacologic class. The FDA National Drug Code Directory lists 85 products in this class from 39 companies, covering 4 drugs by generic name. The main marketing category is generic drugs (ANDA), and the newest product started marketing on July 14, 2026.
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- 39Companies
- 85Products
- 4Drugs by generic name
Drugs in the Direct Thrombin Inhibitor class
Ranked by number of companies that list the drug.
| Drug | Products here | Companies listing it |
|---|---|---|
| Dabigatran etexilate | 48 | 17 |
| Bivalirudin | 15 | 13 |
| Argatroban | 18 | 12 |
| Dabigatran etexilate mesylate | 3 | 1 |
Companies with the most products in this class
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | 9 | pellet; capsule | New drug applications (NDA) | March 16, 2022 |
| A-S Medication Solutions | 5 | capsule; capsule, coated pellets | Generic drugs (ANDA) | May 22, 2024 |
| Hikma Pharmaceuticals USA Inc. | 4 | injection | New drug applications (NDA) | March 25, 2020 |
| Alembic Pharmaceuticals Inc. | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Alembic Pharmaceuticals Limited | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Apotex Corp. | 3 | capsule | Generic drugs (ANDA) | February 13, 2024 |
| Ascend Laboratories, LLC | 3 | capsule, coated pellets | Generic drugs (ANDA) | September 12, 2025 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | May 14, 2025 |
| Camber Pharmaceuticals, Inc. | 3 | capsule | Generic drugs (ANDA) | August 13, 2024 |
| Dr. Reddy's Laboratories Inc. | 3 | capsule | Generic drugs (ANDA) | February 28, 2025 |
| Major Pharmaceuticals | 3 | capsule, coated pellets | Generic drugs (ANDA) | June 23, 2025 |
| Novadoz Pharmaceuticals LLC | 3 | capsule | Generic drugs (ANDA) | August 12, 2024 |
| Par Health USA, LLC | 3 | injection; injection, solution | Generic drugs (ANDA) | June 19, 2023 |
| Accord Healthcare Inc. | 2 | injection, powder, lyophilized, for solution; injection | Generic drugs (ANDA) | October 7, 2021 |
| American Health Packaging | 2 | capsule | Generic drugs (ANDA) | July 14, 2026 |
| AvKARE | 2 | capsule | Generic drugs (ANDA) | November 27, 2024 |
| Eugia US LLC | 2 | injection, powder, lyophilized, for solution; injection, solution | Generic drugs (ANDA) | November 27, 2018 |
| Fresenius Kabi USA, LLC | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 30, 2017 |
| Gland Pharma Limited | 2 | injection, solution; solution | Generic drugs (ANDA) | July 31, 2023 |
| Meitheal Pharmaceuticals Inc. | 2 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 16, 2018 |
| Mullan Pharmaceutical Inc. | 2 | injection | Generic drugs (ANDA) | March 10, 2026 |
| Mylan Institutional LLC | 2 | injection, powder, lyophilized, for solution; injection, solution | Generic drugs (ANDA) | June 5, 2018 |
| Mylan Pharmaceuticals Inc. | 2 | capsule | Generic drugs (ANDA) | February 25, 2025 |
| XLCare Pharmaceuticals, Inc. | 2 | capsule | Generic drugs (ANDA) | August 1, 2023 |
| Amneal Pharmaceuticals LLC | 1 | injection, solution | Generic drugs (ANDA) | January 26, 2018 |
| AvPAK | 1 | capsule | Generic drugs (ANDA) | July 12, 2025 |
| Avenacy, LLC | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | December 18, 2023 |
| Caplin Steriles Limited | 1 | injection | Generic drugs (ANDA) | April 17, 2026 |
| Civica, Inc. | 1 | injection, powder, lyophilized, for solution | Authorized generics (NDA) | December 21, 2020 |
| Dr. Reddy's Laboratories Limited | 1 | injection | Generic drugs (ANDA) | May 31, 2017 |
| Fresenius Kabi USA, LLC | 1 | injection | Generic drugs (ANDA) | May 24, 2021 |
| Hainan Shuangcheng Pharmaceuticals Co., Ltd. | 1 | injection, powder, lyophilized, for solution | Generic drugs (ANDA) | October 23, 2019 |
| Maia Pharmaceuticals, Inc. | 1 | injection, solution | New drug applications (NDA) | May 27, 2024 |
| NorthStar RxLLC | 1 | capsule | Generic drugs (ANDA) | December 1, 2025 |
| Plano Pharmaceuticals Inc. | 1 | solution | New drug applications (NDA) | May 9, 2011 |
| Sagent Pharmaceuticals | 1 | injection, solution | Generic drugs (ANDA) | April 15, 2021 |
| Sandoz Inc | 1 | injection, powder, lyophilized, for solution | Authorized generics (NDA) | June 15, 2015 |
| Slate Run Pharmaceuticals, LLC | 1 | injection, powder, lyophilized, for suspension | Generic drugs (ANDA) | June 30, 2021 |
| Uriel Pharmacy Inc. | 1 | pellet | Unapproved homeopathic products | September 1, 2009 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 37 | 43.5% |
| Injection | 12 | 14.1% |
| Injection, powder, lyophilized, for solution | 11 | 12.9% |
| Capsule, coated pellets | 8 | 9.4% |
| Injection, solution | 7 | 8.2% |
| Pellet | 7 | 8.2% |
| Solution | 2 | 2.4% |
| Injection, powder, lyophilized, for suspension | 1 | 1.2% |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.