Prescription medicine
Sapropterin Brand names: Kuvan, Javygtor, Zelvysia
Sapropterin (Kuvan) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
Check it at the source: the sapropterin FDA label on DailyMed (effective August 26, 2024, BioMarin Pharmaceutical Inc.); the NDA 22181 record on Drugs@FDA; every sapropterin label on DailyMed.
Highlights of the record
FDA label of August 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
Forms and strengths
- 100 mg
- 500 mg
Powder for solution; tablet.
On the market
- Earliest approval on file
- December 13, 2007 Kuvan, Biomarin Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first May 10, 2019; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 1, 2033 Kuvan for solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2022 2 Class I among all firms' recalls; latest November 22, 2024
- FAERS reports
- 6,334 through July 30, 2026
What is sapropterin used for?
From the label: indications and usageKUVAN ® is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe-restricted diet. KUVAN is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin‑ (BH4‑) responsive Phenylketonuria (PKU). KUVAN is to be used in conjunction with a Phe‑restricted diet.
FDA pharmacologic class: Phenylalanine Hydroxylase Activator.
Source: FDA drug label (Kuvan), BioMarin Pharmaceutical Inc., effective August 26, 2024 (SPL set af38711e-8873-4790-a92d-4d583e23fb89), via openFDA; the full label on DailyMed
Is there a generic for sapropterin (Kuvan)?
The FDA approved the first generic sapropterin on May 10, 2019. 13 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sapropterin from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Kuvan for solution, the last expiring on May 1, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2007 earliest approval on file
- 2019 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has sapropterin been recalled?
The FDA's Enforcement Report lists 4 recalls naming sapropterin since 2022: 2 Class I (the most serious), 0 Class II, 2 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 22, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications |
| April 8, 2024 | Class I | Dr. Reddy's Laboratories, Inc. | Sub-potent Drug; powder discoloration associated with decreased potency |
| February 17, 2022 | Class III | Dr. Reddy's Laboratories, Inc. | Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the sapropterin label say about other medicines?
The sapropterin label names 10 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Divalproex | drug interactions | Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved … |
| Levodopa | drug interactions | Clinically Relevant Drug Interactions Levodopa Clinical Impact Sapropterin dihydrochloride may increase the availability of tyrosine, a precursor of levodopa. Neurologic events were reported postmarketing in patients receiving sapropterin and levodopa concomitantly for a non-PKU indication [see Warnings and … |
| Methotrexate | drug interactions | Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved … |
| Nitric oxide | drug interactions | Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; … |
| Phenobarbital | drug interactions | Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved … |
| Sildenafil | drug interactions | Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; … |
| Tadalafil | drug interactions | Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; … |
| Trimethoprim | drug interactions | Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved … |
| Valproic acid | drug interactions | Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved … |
| Vardenafil | drug interactions | Drugs Affecting Nitric Oxide‑Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; … |
Source: FDA drug label (Kuvan), BioMarin Pharmaceutical Inc., effective August 26, 2024 (SPL set af38711e-8873-4790-a92d-4d583e23fb89), via openFDA; the full label on DailyMed
What do FAERS reports show for sapropterin?
The FDA Adverse Event Reporting System holds 6,334 reports that list sapropterin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 74 are coded as a death and 435 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sapropterin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other