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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.

DrugProducts hereCompanies listing it
Dabigatran etexilate4817
Bivalirudin1513
Argatroban1812
Dabigatran etexilate mesylate31

Companies with the most products in this class

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Boehringer Ingelheim Pharmaceuticals, Inc.9pellet; capsuleNew drug applications (NDA)March 16, 2022
A-S Medication Solutions5capsule; capsule, coated pelletsGeneric drugs (ANDA)May 22, 2024
Hikma Pharmaceuticals USA Inc.4injectionNew drug applications (NDA)March 25, 2020
Alembic Pharmaceuticals Inc.3capsuleGeneric drugs (ANDA)August 13, 2024
Alembic Pharmaceuticals Limited3capsuleGeneric drugs (ANDA)August 13, 2024
Apotex Corp.3capsuleGeneric drugs (ANDA)February 13, 2024
Ascend Laboratories, LLC3capsule, coated pelletsGeneric drugs (ANDA)September 12, 2025
Aurobindo Pharma Limited3capsuleGeneric drugs (ANDA)May 14, 2025
Camber Pharmaceuticals, Inc.3capsuleGeneric drugs (ANDA)August 13, 2024
Dr. Reddy's Laboratories Inc.3capsuleGeneric drugs (ANDA)February 28, 2025
Major Pharmaceuticals3capsule, coated pelletsGeneric drugs (ANDA)June 23, 2025
Novadoz Pharmaceuticals LLC3capsuleGeneric drugs (ANDA)August 12, 2024
Par Health USA, LLC3injection; injection, solutionGeneric drugs (ANDA)June 19, 2023
Accord Healthcare Inc.2injection, powder, lyophilized, for solution; injectionGeneric drugs (ANDA)October 7, 2021
American Health Packaging2capsuleGeneric drugs (ANDA)July 14, 2026
AvKARE2capsuleGeneric drugs (ANDA)November 27, 2024
Eugia US LLC2injection, powder, lyophilized, for solution; injection, solutionGeneric drugs (ANDA)November 27, 2018
Fresenius Kabi USA, LLC2injection, powder, lyophilized, for solutionGeneric drugs (ANDA)October 30, 2017
Gland Pharma Limited2injection, solution; solutionGeneric drugs (ANDA)July 31, 2023
Meitheal Pharmaceuticals Inc.2injection, powder, lyophilized, for solutionGeneric drugs (ANDA)July 16, 2018
Mullan Pharmaceutical Inc.2injectionGeneric drugs (ANDA)March 10, 2026
Mylan Institutional LLC2injection, powder, lyophilized, for solution; injection, solutionGeneric drugs (ANDA)June 5, 2018
Mylan Pharmaceuticals Inc.2capsuleGeneric drugs (ANDA)February 25, 2025
XLCare Pharmaceuticals, Inc.2capsuleGeneric drugs (ANDA)August 1, 2023
Amneal Pharmaceuticals LLC1injection, solutionGeneric drugs (ANDA)January 26, 2018
AvPAK1capsuleGeneric drugs (ANDA)July 12, 2025
Avenacy, LLC1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)December 18, 2023
Caplin Steriles Limited1injectionGeneric drugs (ANDA)April 17, 2026
Civica, Inc.1injection, powder, lyophilized, for solutionAuthorized generics (NDA)December 21, 2020
Dr. Reddy's Laboratories Limited1injectionGeneric drugs (ANDA)May 31, 2017
Fresenius Kabi USA, LLC1injectionGeneric drugs (ANDA)May 24, 2021
Hainan Shuangcheng Pharmaceuticals Co., Ltd.1injection, powder, lyophilized, for solutionGeneric drugs (ANDA)October 23, 2019
Maia Pharmaceuticals, Inc.1injection, solutionNew drug applications (NDA)May 27, 2024
NorthStar RxLLC1capsuleGeneric drugs (ANDA)December 1, 2025
Plano Pharmaceuticals Inc.1solutionNew drug applications (NDA)May 9, 2011
Sagent Pharmaceuticals1injection, solutionGeneric drugs (ANDA)April 15, 2021
Sandoz Inc1injection, powder, lyophilized, for solutionAuthorized generics (NDA)June 15, 2015
Slate Run Pharmaceuticals, LLC1injection, powder, lyophilized, for suspensionGeneric drugs (ANDA)June 30, 2021
Uriel Pharmacy Inc.1pelletUnapproved homeopathic productsSeptember 1, 2009

Dosage forms

Dosage formProductsShare
Capsule3743.5%
Injection1214.1%
Injection, powder, lyophilized, for solution1112.9%
Capsule, coated pellets89.4%
Injection, solution78.2%
Pellet78.2%
Solution22.4%
Injection, powder, lyophilized, for suspension11.2%

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.