Data / Drug companies / Topoisomerase Inhibitor
Topoisomerase Inhibitor drugs: 8 drugs from 23 companies in the FDA NDC directory
Topoisomerase Inhibitor is an FDA established pharmacologic class. The FDA National Drug Code Directory lists 57 products in this class from 23 companies, covering 8 drugs by generic name. The main marketing category is generic drugs (ANDA), and the newest product started marketing on September 14, 2026.
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- 23Companies
- 57Products
- 8Drugs by generic name
Drugs in the Topoisomerase Inhibitor class
Ranked by number of companies that list the drug.
| Drug | Products here | Companies listing it |
|---|---|---|
| Irinotecan hydrochloride | 23 | 12 |
| Etoposide | 18 | 9 |
| Topotecan hydrochloride | 4 | 4 |
| Topotecan | 4 | 3 |
| Irinotecan hydrochloide | 3 | 3 |
| Mitoxantrone | 3 | 2 |
| Etoposide phosphate | 1 | 1 |
| Mitoxantrone hydrochloride | 1 | 1 |
Companies with the most products in this class
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 7 | injection | Generic drugs (ANDA) | December 20, 2010 |
| BluePoint Laboratories | 5 | injection, solution, concentrate; injection | Generic drugs (ANDA) | December 1, 2025 |
| Meitheal Pharmaceuticals Inc. | 5 | injection, solution, concentrate | Generic drugs (ANDA) | June 1, 2025 |
| Eugia US LLC | 4 | injection, solution | Generic drugs (ANDA) | April 11, 2022 |
| Fresenius Kabi USA, LLC | 4 | injection, solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | November 30, 2010 |
| Accord Healthcare Inc. | 3 | injection; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | July 8, 2020 |
| Pharmacia & Upjohn Company LLC | 3 | injection, solution | New drug applications (NDA) | December 30, 2024 |
| Qilu Pharmaceutical Co., Ltd. | 3 | injection, solution | Generic drugs (ANDA) | May 3, 2016 |
| Actavis Pharma, Inc. | 2 | injection, solution; injection, powder, lyophilized, for solution | Generic drugs (ANDA) | March 12, 2015 |
| Apotex Corp. | 2 | injection, solution | Generic drugs (ANDA) | July 1, 2023 |
| Avyxa Pharma, LLC | 2 | injection | New drug applications (NDA) | September 14, 2026 |
| Gland Pharma Limited | 2 | injection | Generic drugs (ANDA) | November 18, 2019 |
| Hospira, Inc. | 2 | injection, solution, concentrate; injection, solution | Generic drugs (ANDA) | February 27, 2008 |
| NorthStar Rx LLC | 2 | injection | Generic drugs (ANDA) | November 15, 2020 |
| Sandoz Inc | 2 | capsule | New drug applications (NDA) | July 7, 2017 |
| Xiromed, LLC | 2 | injection | Generic drugs (ANDA) | November 18, 2019 |
| Amneal Pharmaceuticals NY LLC | 1 | capsule | Authorized generics (NDA) | May 15, 2026 |
| H2-Pharma, LLC | 1 | injection, powder, lyophilized, for solution | New drug applications (NDA) | June 1, 2009 |
| Hospira, Inc. | 1 | injection, solution, concentrate | New drug applications (NDA) | February 21, 2011 |
| Ipsen Biopharmaceuticals, Inc. | 1 | injection, powder, for solution | New drug applications (NDA) | October 22, 2015 |
| Mylan Pharmaceuticals Inc. | 1 | capsule | Generic drugs (ANDA) | October 22, 2001 |
| Novartis Pharmaceuticals Corporation | 1 | injection, powder, lyophilized, for solution | New drug applications (NDA) | December 21, 2016 |
| Onesource Specialty Pharma Limited | 1 | capsule | New drug applications (NDA) | May 29, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection | 19 | 33.3% |
| Injection, solution | 17 | 29.8% |
| Injection, solution, concentrate | 10 | 17.5% |
| Capsule | 5 | 8.8% |
| Injection, powder, lyophilized, for solution | 5 | 8.8% |
| Injection, powder, for solution | 1 | 1.8% |
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.