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Last Updated: October 12, 2024

SAPROPTERIN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Sapropterin

A generic version of SAPROPTERIN was approved as sapropterin dihydrochloride by ENDO OPERATIONS on May 10th, 2019.

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Summary for SAPROPTERIN
US Patents:0
Applicants:3
NDAs:8
Drug Prices: Drug price information for SAPROPTERIN
DailyMed Link:SAPROPTERIN at DailyMed
Drug patent expirations by year for SAPROPTERIN
Drug Prices for SAPROPTERIN

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US Patents and Regulatory Information for SAPROPTERIN

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Annora Pharma SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 215534-001 Aug 23, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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
>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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