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 Endo Operations, 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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	38
Patent Applications:	277
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

Anatomical Therapeutic Chemical (ATC) Classes for SAPROPTERIN DIHYDROCHLORIDE

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

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
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015	AB	RX	Yes	No					Y
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	207685-001	Jun 15, 2021	AB	RX	No	No
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	215534-001	Aug 23, 2022	AB	RX	No	No
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes					Y
Endo Operations	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	207207-001	Aug 20, 2019	AB	RX	No	No
Endo Operations	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	210027-001	Aug 20, 2019	AB	RX	No	No
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
European Patent Office	4029519	TÉTRAHYDROBIOPTÉRINE POUR LE TRAITEMENT DES CONDITIONS ASSOCIÉES AUX NIVEAUX ÉLEVÉS DE PHÉNYLALANINE (TETRAHYDROBIOPTERIN FOR TREATING CONDITIONS ASSOCIATED WITH ELEVATED PHENYLALANINE LEVELS)
Spain	2906582
Lithuania	2545939
Japan	2008520574
Slovenia	2545939
Mexico	PA06005451	METODOS Y COMPOSICIONES PARA EL TRATAMIENTO DE TRASTORNOS METABOLICOS. (TREATMENT OF PHENYLKETONURIAS WITH BH4.)
Cyprus	1123764