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Sapropterin dihydrochloride - Generic Drug Details

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What are the generic sources for sapropterin dihydrochloride and what is the scope of freedom to operate?

Sapropterin dihydrochloride is the generic ingredient in two branded drugs marketed by Biomarin Pharm and Par Pharm Inc, and is included in five NDAs. There are eleven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has eighty-seven patent family members in twenty-four countries.

There are three drug master file entries for sapropterin dihydrochloride. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for sapropterin dihydrochloride

International Patents:	87
US Patents:	11
Tradenames:	2
Applicants:	2
NDAs:	5
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	70
Clinical Trials:	32
Patent Applications:	337
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sapropterin dihydrochloride
DailyMed Link:	sapropterin dihydrochloride at DailyMed

Recent Clinical Trials for sapropterin dihydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Censa Pharmaceuticals, Inc.	Phase 1/Phase 2
Merck KGaA	Phase 2
BioMarin Pharmaceutical	Phase 4

See all sapropterin dihydrochloride clinical trials

Recent Litigation for sapropterin dihydrochloride

Identify potential future generic entrants

District Court Litigation

Case Name	Date
BIOMARIN PHARMACEUTICAL INC. v. PAR PHARMACEUTICAL, INC.	2015-03-06

See all sapropterin dihydrochloride litigation

Generic filers with tentative approvals for SAPROPTERIN DIHYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET;ORAL
		100MG/PACKET	POWDER FOR ORAL SOLUTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for sapropterin dihydrochloride

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

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	NDA	Submissiondate
KUVAN	POWDER;ORAL	sapropterin dihydrochloride	205065	2017-02-23
KUVAN	POWDER;ORAL	sapropterin dihydrochloride	205065	2015-11-09
KUVAN	TABLET;ORAL	sapropterin dihydrochloride	022181	2014-06-05

US Patents and Regulatory Information for sapropterin dihydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm Inc	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	207207-001	Aug 20, 2019	AB	RX	No	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007		RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015		RX	Yes	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes			Y
Par Pharm Inc	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	207200-001	May 10, 2019		DISCN	No	No

International Patents for sapropterin dihydrochloride

Country	Patent Number	Estimated Expiration
Cyprus	1113543
Japan	2014012740
China	101678025
Mexico	2007005039
Hong Kong	1139864
Brazil	PI0416566
Canada	2678124