Sapropterin dihydrochloride - Generic Drug Details

What are the generic drug 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, Annora Pharma, Dr Reddys, and Par Pharm Inc, and is included in ten NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sapropterin dihydrochloride has one hundred and seventeen patent family members in twenty-six countries.

There is one drug master file entry for sapropterin dihydrochloride. Six suppliers are listed for this compound.

Summary for sapropterin dihydrochloride

International Patents:	117
US Patents:	10
Tradenames:	2
Applicants:	4
NDAs:	10
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	38
Patent Applications:	309
Drug Prices:	Drug price trends for sapropterin dihydrochloride
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sapropterin dihydrochloride
What excipients (inactive ingredients) are in sapropterin dihydrochloride?	sapropterin dihydrochloride excipients list
DailyMed Link:	sapropterin dihydrochloride at DailyMed

See drug prices for sapropterin dihydrochloride

Recent Clinical Trials for sapropterin dihydrochloride

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

Sponsor	Phase
West China Hospital	Phase 1
Ira Fox	Phase 1/Phase 2
West China Second University Hospital	Phase 2

See all sapropterin dihydrochloride clinical trials

Pharmacology for sapropterin dihydrochloride

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

Paragraph IV (Patent) Challenges for SAPROPTERIN DIHYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	500 mg per packet	205065	1	2017-02-23
KUVAN	Powder for Oral Solution	sapropterin dihydrochloride	100 mg per packet	205065	1	2015-11-09
KUVAN	Tablets	sapropterin dihydrochloride	100 mg	022181	1	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	TABLET;ORAL	207200-001	May 10, 2019	AB	RX	No	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes					Y
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420-002	Aug 18, 2022	AB	RX	No	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes					Y
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes					Y

International Patents for sapropterin dihydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2486899	КОМПОЗИЦИИ ТЕТРАГИДРОБИОПТЕРИНА И СПОСОБЫ ЕГО КОЛИЧЕСТВЕННОЙ ОЦЕНКИ (COMPOSITIONS OF TETRAHYDROBIOPTERINE AND METHODS OF ITS QUANTITATIVE ASSESSMENT)
Denmark	3138566
Slovenia	2139485
Germany	22154751
Portugal	2545939
Hong Kong	1139864	METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING
Hungary	E058126