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  1. pharmadog
  2. ›drugs
  3. ›Sephience
drug · small molecule
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sepiapterin

Marketedupdated 3mo ago
by $PTC PTC INC.🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for phenylketonuria and 2 investigational indications.

all catalysts(0)

nothing on the calendar yet

Trials studying sepiapterin

  • phase3A Study of Sepiapterin in Participants With Phenylketonuria (PKU)recruitingn=56

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 28, 2030
~4.0 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)

  • Mar 6, 2042method-of-use (U-4250)US 12257252
  • Mar 6, 2042method-of-use (U-4250)US 12257252
  • Sep 4, 2038formulationUS 11752154
  • Sep 4, 2038formulationUS 11752154
  • Sep 4, 2038method-of-use (U-4251)US 12213982
  • Sep 4, 2038method-of-use (U-4251)US 12213982
  • Apr 16, 2038compositionUS 11072614
  • Apr 16, 2038compositionUS 11072614

FDA exclusivities (2)

  • Jul 28, 2030NCENew Chemical Entity (5y)4.0y
  • Jul 28, 2030NCENew Chemical Entity (5y)4.0y

News(0)

no news has mentioned this drug yet

brand
Sephience
generic
sepiapterin
indication
Hyperphenylalaninemia
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 37m ago
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