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Last Updated: April 19, 2024

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 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
University of Pittsburgh	Phase 1/Phase 2
Ira Fox	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
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	POWDER;ORAL	205065-002	Oct 27, 2015	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Par Pharm Inc	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	TABLET;ORAL	207200-001	May 10, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biomarin Pharm	KUVAN	sapropterin dihydrochloride	TABLET;ORAL	022181-001	Dec 13, 2007	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>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
Russian Federation	2470642	АНАЛОГИ ПТЕРИНА ДЛЯ ЛЕЧЕНИЯ СОСТОЯНИЯ, ЧУВСТВИТЕЛЬНОГО К ВН4 (PTERIN ANALOGUES FOR TREATING BH4 SENSITIVE CONDITION)	⤷ Try a Trial
Japan	2008520574		⤷ Try a Trial
Canada	2678125	FORMES CRISTALLINES DE DIHYDROCHLORURE DE (6R)-L-ERYTHRO-TETRAHYDROBIOPTERINE (CRYSTALLINE FORMS OF (6R)-L-ERYTHRO-TETRAHYDROBIOPTERIN DIHYDROCHLORIDE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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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.