Details for New Drug Application (NDA): 022181

✉ Email this page to a colleague

NDA 022181 describes KUVAN, which is a drug marketed by Biomarin Pharm and is included in two NDAs. It is available from one supplier. 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. Seven suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

Summary for 022181

Tradename:	KUVAN
Applicant:	Biomarin Pharm
Ingredient:	sapropterin dihydrochloride
Patents:	9

Pharmacology for NDA: 022181

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Phenylalanine Hydroxylase Activators

Suppliers and Packaging for NDA: 022181

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181	NDA	BioMarin Pharmaceutical Inc.	68135-300	68135-300-02	120 TABLET in 1 BOTTLE (68135-300-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Dec 13, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Try for Free	Patent Expiration:	May 16, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try for Free	Patent Expiration:	May 17, 2025	Product Flag?		Substance Flag?		Delist Request?
Patent:	⤷ Try for Free	Patent Expiration:	May 17, 2025	Product Flag?		Substance Flag?		Delist Request?

Expired US Patents for NDA 022181

Subscribe to access the full database, or Try for Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	⤷ Try for Free	⤷ Try for Free
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	⤷ Try for Free	⤷ Try for Free
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	⤷ Try for Free	⤷ Try for Free
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	⤷ Try for Free	⤷ Try for Free
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.