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  1. pharmadog
  2. ›drugs
  3. ›GLYCEROL PHENYLBUTYRATE
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GLYCEROL PHENYLBUTYRATE

Marketedupdated 3mo ago
by Lupin Ltd
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval6 co-mentions · 3 sources
  • drugphenylbutyrate3 co-mentions · 3 sources
  • tagSmall Molecule2 co-mentions · 2 sources
  • companyAurobindo Pharma Ltd1 co-mentions · 1 sources

all catalysts(2)

approval · 2
Apr 15, 2026
approval
4mo ago
GLYCEROL PHENYLBUTYRATE — FDA approval
GLYCEROL PHENYLBUTYRATE
→
Apr 15, 2026
approval
4mo ago
GLYCEROL PHENYLBUTYRATE — FDA approval
GLYCEROL PHENYLBUTYRATE
→

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 22, 2030
~4.1 years out

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

patents (14)

  • Sep 22, 2030method-of-use (U-1816)US 100459584.1y
  • Sep 22, 2030method-of-use (U-1816)US 100459594.1y
  • Sep 22, 2030method-of-use (U-1816)US 101830024.1y
  • Sep 22, 2030method-of-use (U-1816)US 101830034.1y
  • Sep 22, 2030method-of-use (U-1816)US 101830044.1y
  • Sep 22, 2030method-of-use (U-1816)US 101830054.1y
  • Sep 22, 2030method-of-use (U-1816)US 101830064.1y
  • Sep 22, 2030method-of-use (U-1816)US 106680404.1y
  • Sep 22, 2030method-of-use (U-1383)US 86420124.1y
  • Sep 22, 2030method-of-use (U-1816)US 92542784.1y
  • Sep 22, 2030method-of-use (U-1816)US 93269664.1y
  • Sep 22, 2030method-of-use (U-1383)US 95611974.1y
  • Sep 22, 2030method-of-use (U-1816)US 99623594.1y
  • Sep 22, 2030method-of-use (U-1816)US 99996084.1y

FDA exclusivities (1)

  • Apr 15, 2026PCPC

News(0)

no news has mentioned this drug yet

brand
GLYCEROL PHENYLBUTYRATE
generic
GLYCEROL PHENYLBUTYRATE
indication
Urea Cycle Disorders
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 13m ago
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