Drug
Who makes sapropterin dihydrochloride?
10 companies list sapropterin dihydrochloride as a human prescription drug, including under the names Kuvan, JAVYGTOR, ZELVYSIA. Forms: powder, for solution; tablet. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing sapropterin dihydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Par Health USA, LLCIndia | powder, for solution; tablet | ANDAANDA207200, ANDA207207, ANDA210027 | 3 | 5 |
| BioMarin International LimitedUnited States | powder, for solution; tablet | NDANDA022181, NDA205065 | 3 | 2 |
| Camber Pharmaceuticals, Inc.United States | powder, for solution; tablet | ANDAANDA215420, ANDA215534 | 3 | 1 |
| Dr. Reddys Laboratories Limited | powder, for solution; tablet | ANDAANDA207685, ANDA209452, ANDA215798 | 3 | 0 |
| NorthStar RxLLC | powder, for solution; tablet | ANDAANDA215420, ANDA215534 | 3 | 0 |
| Micro Labs LimitedIndia | powder, for solution | ANDAANDA219511 | 2 | 5 |
| Aucta Pharmaceuticals, Inc.United States | powder, for solution | ANDAANDA218645 | 2 | 2 |
| TruPharma LLC. | powder, for solution | ANDAANDA216432 | 2 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA216797 | 1 | 6 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA218797 | 1 | 4 |
Bulk ingredient listings
- Biophore India Pharmaceuticals Private LimitedIndia · 1 NDC
- DOTTIKON EXCLUSIVE SYNTHESIS AGSwitzerland · 1 NDC
- Dipharma Francis SrlItaly · 1 NDC
- Honour Lab LimitedIndia · 1 NDC
- Maithri Drugs Private LimitedIndia · 1 NDC
- SOLARA ACTIVE PHARMA SCIENCES LIMITEDIndia · 1 NDC
- Seven Star Pharmaceutical Co., Ltd.Taiwan · 1 NDC
- Shiratori Pharmaceutical Co., Ltd.Japan · 1 NDC
- Teva Pharmaceutical Works Private Limited CompanyHungary · 1 NDC
Orange Book patents
2 unexpired patents list sapropterin dihydrochloride as the active ingredient, expiring between Nov 2032 and May 2033. Application holder: BIOMARIN PHARMACEUTICAL INC.
Enquiry
Common questions
- Who makes sapropterin dihydrochloride?
- 10 companies list sapropterin dihydrochloride as a human prescription drug in the openFDA NDC Directory, led by Par Health USA, LLC, BioMarin International Limited, Camber Pharmaceuticals, Inc., Dr. Reddys Laboratories Limited, NorthStar RxLLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Kuvan?
- 9 companies list sapropterin dihydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies sapropterin dihydrochloride active ingredient?
- 9 companies list sapropterin dihydrochloride as a bulk ingredient, including Biophore India Pharmaceuticals Private Limited, DOTTIKON EXCLUSIVE SYNTHESIS AG, Dipharma Francis Srl, Honour Lab Limited.