Orange Book product · Brand (NDA)

KUVAN

SAPROPTERIN DIHYDROCHLORIDE

Brand (NDA)NDA 022181TE ABRX BIOMARIN PHARM

Dec 13, 2007

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 13, 2007
18 yr 9 mo ago
Patent 7566462 expires
Listed drug product patent expiration.
Nov 16, 2025
7 mo ago
Patent 8003126 expires
Listed listed patent expiration.
Nov 16, 2025
7 mo ago
Patent 7566462*PED expires
Listed listed patent expiration.
May 16, 2026
1 mo ago
Patent 8003126*PED expires
Listed listed patent expiration.
May 16, 2026
1 mo ago
Today

Active ingredient

SAPROPTERIN DIHYDROCHLORIDE

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022181

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7566462	Nov 16, 2025	7 mo ago	Product
8003126	Nov 16, 2025	7 mo ago
7566462*PED	May 16, 2026	1 mo ago
8003126*PED	May 16, 2026	1 mo ago