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Last Updated: December 19, 2025

SAPROPTERIN Drug Patent Profile

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When do Sapropterin patents expire, and when can generic versions of Sapropterin launch?

Sapropterin is a drug marketed by Annora Pharma, Dr Reddys, Hopewell Pharma, Ph Health, Aurobindo Pharma, and Zenara. and is included in eleven NDAs.

The generic ingredient in SAPROPTERIN is sapropterin dihydrochloride. There are three drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sapropterin dihydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sapropterin

A generic version of SAPROPTERIN was approved as sapropterin dihydrochloride by PH HEALTH on May 10^th, 2019.

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Summary for SAPROPTERIN

US Patents:	0
Applicants:	6
NDAs:	11
Drug Prices:	Drug price information for SAPROPTERIN
DailyMed Link:	SAPROPTERIN at DailyMed

Drug patent expirations by year for SAPROPTERIN

Drug Prices for SAPROPTERIN

US Patents and Regulatory Information for SAPROPTERIN

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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
Annora Pharma	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215420-001	Aug 18, 2022	AB	RX	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Ph Health	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	207207-001	Aug 20, 2019	AB	RX	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
Dr Reddys	SAPROPTERIN DIHYDROCHLORIDE	sapropterin dihydrochloride	POWDER;ORAL	215798-001	May 13, 2022	AB	RX	No	No	⤷ Get Started Free	⤷ Get Started Free				⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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