Data / Drug companies / Darunavir
Darunavir: 14 companies and 30 products in the FDA NDC directory
Darunavir is listed in the FDA National Drug Code Directory by 14 companies, with 30 products in commercial distribution. 25 of the products (83.3%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet; suspension, and the newest product started marketing on January 21, 2025.
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- Companies listing it
- 14
- Products
- 30
- Generic (ANDA) products
- 25 (83.3%)
- Application numbers
- 11
- Routes
- Oral
- Brand names
- Prezista
- openFDA record search
- api.fda.gov
Companies that list darunavir
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Janssen Products, LP | 5 | tablet, film coated; suspension | New drug applications (NDA) | November 9, 2012 |
| Camber Pharmaceuticals, Inc. | 4 | tablet, film coated | Generic drugs (ANDA) | January 21, 2025 |
| American Health Packaging | 2 | tablet | Generic drugs (ANDA) | June 25, 2024 |
| Amneal Pharmaceuticals NY LLC | 2 | tablet, film coated | Generic drugs (ANDA) | December 9, 2023 |
| Aurobindo Pharma Limited | 2 | tablet, film coated | Generic drugs (ANDA) | November 28, 2023 |
| Cipla USA Inc. | 2 | tablet | Generic drugs (ANDA) | November 29, 2023 |
| Dr. Reddy's Laboratories Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | November 29, 2023 |
| Lupin Pharmaceuticals, Inc. | 2 | tablet, film coated | Generic drugs (ANDA) | June 1, 2023 |
| Novadoz Pharmaceuticals LLC | 2 | tablet, film coated | Generic drugs (ANDA) | November 28, 2023 |
| Viona Pharmaceuticals Inc | 2 | tablet, film coated | Generic drugs (ANDA) | May 1, 2024 |
| Zydus Lifesciences Limited | 2 | tablet, film coated | Generic drugs (ANDA) | May 1, 2024 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | November 29, 2023 |
| Bryant Ranch Prepack | 1 | tablet, film coated | Generic drugs (ANDA) | November 28, 2023 |
| NuCare Pharmaceuticals,Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | November 28, 2023 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 24 | 80% |
| Tablet | 5 | 16.7% |
| Suspension | 1 | 3.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 25 | 83.3% |
| New drug applications (NDA) | 5 | 16.7% |
Pharmacologic classes
| Class | Products |
|---|---|
| Protease Inhibitor | 30 |
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.