OpenRx Open Medications Explorer
© 2026 OpenRx · public-domain U.S. government data
On this page

Kuvan

sapropterin dihydrochloride · Powder, for Solution

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Kuvan
Generic name
sapropterin dihydrochloride
Dosage form
Powder, for Solution
Route
Oral
Marketing category
NDA · NDA
Labeler
BioMarin Pharmaceutical Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Sapropterin Dihydrochloride 100 mg/1 1486687 View
Sapropterin Dihydrochloride 500 mg/1 1486687 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder, for Solution
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Breast Cancer Resistance Protein Inhibitors [MoA] MoA All 44 members
P-Glycoprotein Inhibitors [MoA] MoA All 105 members
Phenylalanine Hydroxylase Activator [EPC] EPC 5 members — no class page
Phenylalanine Hydroxylase Activators [MoA] MoA 5 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
205065
Application type
NDA · New Drug Application
Approval date
December 19, 2013
Sponsor
BIOMARIN PHARM
Products on application
2
Submissions recorded
7
Products approved under application 205065.
Product Trade name Form Strength Ingredient Status TE Flags
205065-001 KUVAN FOR SOLUTION SAPROPTERIN DIHYDROCHLORIDE Prescription AB RLD RS
205065-002 KUVAN FOR SOLUTION SAPROPTERIN DIHYDROCHLORIDE Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9216178 November 1, 2032 001 No January 15, 2016
9216178 November 1, 2032 002 No January 15, 2016
9216178*PED May 1, 2033 001 No —
9216178*PED May 1, 2033 002 No —

Approval history

Source: Drugs@FDA
Most recent submissions on application 205065.
Type No. Action Status Date Review
Supplement 8 Labeling Approved August 26, 2024 Standard
Supplement 6 Labeling Approved March 16, 2020 Standard
Supplement 7 Labeling Approved December 13, 2019 Standard
Supplement 5 Labeling Approved May 2, 2019 Standard
Supplement 2 Labeling Approved August 9, 2016 Standard
Supplement 1 Manufacturing (CMC) Approved October 28, 2015 Standard
Original application 1 Type 3 - New Dosage Form Approved December 19, 2013 Standard

Review documents

  • 0 · Supplement · October 2, 2024
  • 0 · Supplement · September 9, 2024
  • 0 · Supplement · March 17, 2020
  • 0 · Supplement · March 17, 2020
  • 0 · Supplement · December 17, 2019
  • 0 · Supplement · December 17, 2019
  • 0 · Supplement · May 3, 2019
  • 0 · Supplement · May 3, 2019
  • 0 · Supplement · August 9, 2016
  • 0 · Supplement · August 9, 2016
  • 0 · Supplement · April 8, 2016
  • 0 · Original application · March 6, 2014
  • 0 · Original application · March 6, 2014
  • 0 · Original application · December 23, 2013
  • 0 · Original application · December 20, 2013

Adverse event reports

Source: openFDA FAERS
6,334
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SAPROPTERIN DIHYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
68135-301-22 68135-301 BioMarin Pharmaceutical Inc. 30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11) February 21, 2014
68135-482-11 68135-482 BioMarin Pharmaceutical Inc. 30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10) May 27, 2015
68135-301 68135-301 BioMarin Pharmaceutical Inc. — February 21, 2014
68135-482 68135-482 BioMarin Pharmaceutical Inc. — May 27, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.