PillRx only · Tablet · Oral
Sapropterin Dihydrochloride
Brands: Javygtor · Kuvan · Sapropterin Dihydrochloride
7 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US7 NDCs
7 active makers
7 active makers
UKComing
soon
soon
CAComing
soon
soon
AUComing
soon
soon
EUComing
soon
soon
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
498
Rx · 2026 Q1
175K
Units dispensed
-30%
Rx vs. year ago
5
Quarters · since 2025 Q1
Who makes it7 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Aurobindo Pharma Limited | unknown | 3 | SUPPLYING |
| Dr.Reddy's laboratories Limited | unknown | 3 | SUPPLYING |
| Hikma Pharmaceuticals USA Inc. | unknown | 1 | SUPPLYING |
| NorthStar RxLLC | unknown | 1 | SUPPLYING |
| BioMarin Pharmaceutical Inc. | unknown | 1 | SUPPLYING |
| Camber Pharmaceuticals, Inc. | unknown | 1 | SUPPLYING |
| Par Health USA, LLC | unknown | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Nov 22, 2024RECALLRecall (Class III): Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories …
Failed Impurities/Degradation Specifications — Recalling firm: Dr. Reddy's Laboratories, Inc. — U.S. Nationwide