For hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive…. Sold as Kuvan. Every FDA application for this active ingredient: 2 branded and 13 generic.
As of Nov 15, 2026, FDA lists 15 applications for Sapropterin Dihydrochloride (sold as Kuvan), first approved Dec 13, 2007, with 3 new uses approved and 0 published complete response letters.
| Sapropterin Dihydrochloride | Part D | $14.0M | -11% | 156 |
| Javygtor | Part D | $3.9M | +16% | 28 |
| Kuvan | Part D | $2.7M | -21% | 16 |
| Impact Of A Phe-Restricted Diet On Gut Health In Children With PKUPhenylketonuria · Birmingham Women's and Children's NHS Foundation Trust | — | Recruiting | Jul 27, 2026 |
| Prevalence and Determinants of Obesity in PKU PatientsPhenylketonuria (PKU) · Christel Tran | — | Enrolling by invitation | Jul 14, 2026 |
| A Single Patient Study of Sapropterin for Multisystem Smooth Muscle Dysfunction SyndromeMultisystemic Smooth Muscle Dysfunction Syndrome · Gregor Andelfinger | Not applicable | Recruiting | May 7, 2026 |
| Evaluation of BH4 Responsiveness in Our PKU PatientsPhenylketonuria (PKU) · Sohag University | Phase 1 | Active, not recruiting | Dec 1, 2025 |
| Novel Approaches for Improving Vascular Function in Veterans With HFpEFHeart Failure With Preserved Ejection Fraction, Inflammation · VA Office of Research and Development | Phase 1 | Recruiting | Mar 15, 2024 |
| The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent ClaudicationClaudication, Intermittent, Peripheral Artery Disease · Louis Messina | Phase 1 | Active, not recruiting | Mar 16, 2021 |
| Neurovascular Transduction During Exercise in Chronic Kidney DiseaseRenal Insufficiency, Chronic · Emory University | Phase 2 | Recruiting | Oct 28, 2016 |
| Dec 13, 2007 | KuvanNDA 22181 · New molecular entity | Biomarin Pharm | 12 | Marketed |
| Dec 19, 2013 | KuvanNDA 205065 · New dosage form | Biomarin Pharm | 6 | Marketed |
| May 10, 2019 | Sapropterin DihydrochlorideANDA 207200 | Ph Health | 1 | Marketed |
| Aug 20, 2019 | Sapropterin DihydrochlorideANDA 207207 | Ph Health | 2 | Marketed |
| Aug 20, 2019 | Sapropterin DihydrochlorideANDA 210027 | Ph Health | 3 | Marketed |
| Mar 30, 2021 | Sapropterin DihydrochlorideANDA 209452 | Dr Reddys | 3 | Marketed |
| Jun 15, 2021 | Sapropterin DihydrochlorideANDA 207685 | Dr Reddys | 2 | Marketed |
| May 13, 2022 | Sapropterin DihydrochlorideANDA 215798 | Dr Reddys | 3 | Marketed |
| Aug 18, 2022 | Sapropterin DihydrochlorideANDA 215420 | Annora Pharma | 1 | Marketed |
| Aug 23, 2022 | Sapropterin DihydrochlorideANDA 215534 | Annora Pharma | 1 | Marketed |
| Apr 29, 2025 | ZelvysiaANDA 218645 | Aucta | 0 | Marketed |
| Jun 9, 2025 | Sapropterin DihydrochlorideANDA 216797 | Aurobindo Pharma | 0 | Marketed |
| Jun 11, 2025 | Sapropterin DihydrochlorideANDA 218797 | Hikma | 0 | Marketed |
| Sep 3, 2025 | Sapropterin DihydrochlorideANDA 216432 | Hopewell Pharma | 0 | Marketed |
| Jan 8, 2026 | Sapropterin DihydrochlorideANDA 219511 | Micro Labs | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Aurobindo Pharma
Hikma