Orange Book product · Brand (NDA)

KUVAN

SAPROPTERIN DIHYDROCHLORIDE

Brand (NDA)NDA 205065TE ABRX BIOMARIN PHARM

Dec 19, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 19, 2013
12 yr 8 mo ago
Today
Patent 9216178 expires
Listed drug product patent expiration.
Nov 01, 2032
in 6 yr 6 mo
Patent 9216178*PED expires
Listed listed patent expiration.
May 01, 2033
in 7 yr

Active ingredient

SAPROPTERIN DIHYDROCHLORIDE

Strength

100MG/PACKET

Dosage form

POWDER

Route

ORAL

TE code

Application

NDA 205065

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
9216178	Nov 01, 2032	in 6 yr 6 mo	Product
9216178*PED	May 01, 2033	in 7 yr