Sapropterin dihydrochloride - Generic Drug Details

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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
West China Second University Hospital	Phase 2
University of Pittsburgh	Phase 1/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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	207207-001	Aug 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215798-001	May 13, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-001	Dec 19, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for sapropterin dihydrochloride

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Country	Patent Number	Title	Estimated Expiration
South Korea	20150080026	테트라하이드로바이오프테린 투여 방법, 관련 조성물 및 측정 방법 (METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING)	⤷ Sign Up
Taiwan	200624120	Stable tablet formulation	⤷ Sign Up
Brazil	PI0809470	MÉTODOS DE ADMINISTRAR TETRAIDROBIOPTERINA, COMPOSIÇÕES ASSOCIADAS, E MÉTODOS DE MEDIÇÃO	⤷ Sign Up
Spain	2755334		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009088530		⤷ Sign Up
South Korea	20100016445	METHODS OF ADMINISTERING TETRAHYDROBIOPTERIN, ASSOCIATED COMPOSITIONS, AND METHODS OF MEASURING	⤷ Sign Up
Croatia	P20210239		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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