Last Updated: May 14, 2026

Sapropterin - Generic Drug Details


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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
Ph Health SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 207200-001 May 10, 2019 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Micro Labs SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 219511-001 Jan 8, 2026 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aucta ZELVYSIA sapropterin dihydrochloride POWDER;ORAL 218645-001 Apr 29, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tp Anda Holdings SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 216432-001 Sep 3, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Aurobindo Pharma SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride TABLET;ORAL 216797-001 Jun 9, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Tp Anda Holdings SAPROPTERIN DIHYDROCHLORIDE sapropterin dihydrochloride POWDER;ORAL 216432-002 Sep 3, 2025 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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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