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KUVAN

NDA

SAPROPTERIN DIHYDROCHLORIDE | N022181 | BIOMARIN PHARMACEUTICAL INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expired (2)TodayPED (+6 mo)

2026

Today

7566462

May. 16, 2026

8003126

May. 16, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BIOMARIN PHARMACEUTICAL INC. et al v. PAR PHARMACEUTICAL, INC. 3:2015cv01706 8 patentsANDA 207200sapropterin dihydrochloride	D.N.J.	2015-03-06	Terminated 2017-04-18	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
K&L Gates, L.L.P. - Citizen Petition FDA-2013-P-0846 · 4 docket documents K&L Gates filed this citizen petition on behalf of a generic drug manufacturer client pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA permit the use of KUVAN (sapropterin dihydrochloride) tablets obtained in Israel as the reference product for bioequiv	505(q)	2013-07-23	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

37 trials from ClinicalTrials.gov — 1 recruiting, 27 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Neurovascular Transduction During Exercise in Chronic Kidney Disease NCT02947750	Phase 2	Recruiting	Emory University	150	2016-10 → 2027-04-30
Sapropterin Expanded Access Program NCT00484991	—	APPROVED_FOR_MARKETING	BioMarin Pharmaceutical	—	—
Impact of KUVAN® on Gastric Relaxation in Women With Diabetic Gastroparesis.NCT01135186	N/A	Completed	Stanford University	9	2010-05 → 2012-11
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response NCT00841100	Phase 2	Completed	University of Miami	21	2008-12 → 2011-07-19
Kuvan® in Phenylketonuria Patients Less Than 4 Years Old NCT01376908	Phase 3	Completed	BioMarin Pharmaceutical	56	2011-06 → 2017-02-17
Kuvan®'s Effect on the Cognition of Children With Phenylketonuria NCT01965912	Phase 4	Completed	BioMarin Pharmaceutical	34	2013-10 → 2023-01-04
Tetrahydrobiopterin Treatment in Children With Idiopathic Cognitive Developmental Disorders NCT01141595	N/A	Completed	The University of Texas Health Science Center, Houston	10	2010-07 → 2011-09
Study of Phenoptin in Subjects With Phenylketonuria Who Participated in Protocols PKU-004 or PKU-006 NCT00332189	Phase 3	Completed	BioMarin Pharmaceutical	111	2006-07 → 2009-08
A Phase 1 Study to Evaluate Effects of Sapropterin Dihydrochloride on QTc Intervals in Healthy Adult Subjects NCT00789568	Phase 1	Completed	BioMarin Pharmaceutical	56	2008-10 → 2009-10
Phase 3 Open-label Study to Evaluate the Response and Safety of Kuvan® in Subjects With Phenylketonuria NCT01732471	Phase 3	Completed	Merck KGaA, Darmstadt, Germany	90	2012-11 → 2013-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2532.66

Highest Price

$2532.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
68135-0300-02KUVAN 100MG TAB	$2532.66	FSS	BioMarin Pharmaceutical, Inc.	05/31/2026
68135-0300-02KUVAN 100MG TAB	$2532.66	Big4	BioMarin Pharmaceutical, Inc.	05/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Kuvan (2024)

Total Spending

$3.5M

Total Claims

229

Beneficiaries

Avg Cost/Unit

$126.92

Spending Trend

$29.7M(2019)→$30.6M(2020)→$19.5M(2021)→$10.3M(2022)→$6.8M(2023)→$3.5M(2024)

YoY Change:-6.7%

5yr CAGR:-0.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE

DMF 266822012

ASYMCHEM LABORATORIES TIANJIN CO LTDSAPROPTERIN

DMF 284162014

INNOPHARMAX INCSAPROPTERIN DIHYDROCHLORIDE

DMF 335532019

HONOUR LAB LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 339282019

SOLARA ACTIVE PHARMA SCIENCES LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 341852019

DIPHARMA SASAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS)

DMF 349262020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 361472021

MAITHRI DRUGS PRIVATE LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 410772024

CHONGQING MIDECO PHARMACEUTICAL CO LTDSAPROPTERIN DIHYDROCHLORIDE

DMF 421462025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Sep 9, 2024	SUPPL -24	View Letter (PDF)
Mar 17, 2020	SUPPL -20	View Letter (PDF)
Dec 17, 2019	SUPPL -18	View Letter (PDF)
May 3, 2019	SUPPL -19	View Letter (PDF)
Feb 13, 2019	SUPPL -17	View Letter (PDF)
Jun 15, 2016	SUPPL -14	View Letter (PDF)
Apr 24, 2014	SUPPL -13	View Letter (PDF)
Dec 20, 2013	SUPPL -10	View Letter (PDF)
Dec 20, 2013	SUPPL -9	View Letter (PDF)
Jun 24, 2008	SUPPL -1	View Letter (PDF)
Dec 13, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

RLDAB

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 13, 2007

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7566462	Nov 16, 2025PED: May 16, 2026	PED	—	Yes	—	—
8003126	Nov 16, 2025PED: May 16, 2026	PED	—	—	—	—