Data / Drug companies / Sapropterin dihydrochloride
Sapropterin dihydrochloride: 10 companies and 23 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Sapropterin dihydrochloride is listed in the FDA National Drug Code Directory by 10 companies, with 23 products in commercial distribution. 20 of the products (87.0%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are powder, for solution; tablet, and the newest product started marketing on April 1, 2026.
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- Companies listing it
- 10
- Products
- 23
- Generic (ANDA) products
- 20 (87.0%)
- Application numbers
- 15
- Routes
- Oral
- Brand names
- Javygtor, Kuvan, Zelvysia
- openFDA record search
- api.fda.gov
Companies that list sapropterin dihydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| BioMarin Pharmaceutical Inc. | 3 | powder, for solution; tablet | New drug applications (NDA) | May 27, 2015 |
| Camber Pharmaceuticals, Inc. | 3 | powder, for solution; tablet | Generic drugs (ANDA) | August 23, 2022 |
| Dr. Reddy's Laboratories Inc. | 3 | powder, for solution; tablet | Generic drugs (ANDA) | November 16, 2022 |
| NorthStar RxLLC | 3 | powder, for solution; tablet | Generic drugs (ANDA) | December 1, 2023 |
| Par Health USA, LLC | 3 | powder, for solution; tablet | Generic drugs (ANDA) | October 1, 2020 |
| Aucta Pharmaceuticals, Inc. | 2 | powder, for solution | Generic drugs (ANDA) | April 29, 2025 |
| Micro Labs Limited | 2 | powder, for solution | Generic drugs (ANDA) | April 1, 2026 |
| TruPharma, LLC | 2 | powder, for solution | Generic drugs (ANDA) | January 30, 2026 |
| Aurobindo Pharma Limited | 1 | tablet | Generic drugs (ANDA) | June 9, 2025 |
| Hikma Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | October 23, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Powder, for solution | 16 | 69.6% |
| Tablet | 7 | 30.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 20 | 87% |
| New drug applications (NDA) | 3 | 13% |
Pharmacologic classes
| Class | Products |
|---|---|
| Phenylalanine Hydroxylase Activator | 23 |
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.