Details for New Drug Application (NDA): 205065

NDA 205065 describes KUVAN, which is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from two suppliers. There are ten patents protecting this drug and three Paragraph IV challenges. Additional details are available on the KUVAN profile page.

The generic ingredient in KUVAN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

Summary for 205065

Tradename:	KUVAN
Applicant:	Biomarin Pharm
Ingredient:	sapropterin dihydrochloride
Patents:	6

Pharmacology for NDA: 205065

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators

Suppliers and Packaging for NDA: 205065

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065	NDA	BioMarin Pharmaceutical Inc.	68135-301	68135-301-22	30 PACKET in 1 CARTON (68135-301-22) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-301-11)
KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065	NDA	BioMarin Pharmaceutical Inc.	68135-482	68135-482-11	30 PACKET in 1 CARTON (68135-482-11) / 1 POWDER, FOR SOLUTION in 1 PACKET (68135-482-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;ORAL			Strength	100MG/PACKET
Approval Date:	Dec 19, 2013	TE:	AB	RLD:	Yes
Patent:		Patent Expiration:	May 17, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:		Patent Expiration:	May 17, 2025	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:		Patent Expiration:	May 17, 2025	Product Flag?		Substance Flag?		Delist Request?	Y

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