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  1. pharmadog
  2. ›drugs
  3. ›SAPROPTERIN DIHYDROCHLORIDE
drug · small molecule
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SAPROPTERIN DIHYDROCHLORIDE

Marketedupdated 3mo ago
by $RLFTY MindMaze Therapeutics Holding SA🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 5
  • companyDr. Reddy's Laboratories Ltd2 co-mentions · 1 sources
  • tagApproval2 co-mentions · 1 sources
  • companyMicro Labs Ltd1 co-mentions · 1 sources
  • tagSmall Molecule1 co-mentions · 1 sources
  • tagRecall1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for phenylketonuria and hyperphenylalaninemia and 10 investigational indications.

targets

Phenylalanine-4-hydroxylase

all catalysts(1)

approval · 1
Jan 8, 2026
approval
7mo ago
SAPROPTERIN DIHYDROCHLORIDE — FDA approval
SAPROPTERIN DIHYDROCHLORIDE
→

Trials studying SAPROPTERIN DIHYDROCHLORIDE

  • phase2PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDACrecruitingn=20
  • —Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponderscompletedn=21

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 1, 2032
~6.2 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (8)

  • May 1, 2033patentUS 9216178*PED
  • May 1, 2033patentUS 9216178*PED
  • Nov 1, 2032formulationUS 9216178
  • Nov 1, 2032formulationUS 9216178
  • May 16, 2026patentUS 7566462*PED
  • May 16, 2026patentUS 8003126*PED
  • Nov 16, 2025formulationUS 7566462
  • Nov 16, 2025patentUS 8003126

News(0)

no news has mentioned this drug yet

brand
SAPROPTERIN DIHYDROCHLORIDE
trade names
Kuvan, Sapropterin dipharma
generic
SAPROPTERIN DIHYDROCHLORIDE
MOA
Phenylalanine-4-hydroxylase activator
indication
Phenylketonuria (PKU)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 2h ago
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