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  2. ›drugs
  3. ›Carbaglu
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carglumic acid ODT

Marketedupdated 3mo ago
by Recordati Rare Diseases Inc
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying carglumic acid ODT

  • —An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatricsrecruitingn=20
  • —Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approachrecruitingn=95

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 22, 2028
~1.5 years out

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

FDA exclusivities (1)

  • Jan 22, 2028ODE-345Orphan Drug (7y)1.5y

News(0)

no news has mentioned this drug yet

brand
Carbaglu
generic
carglumic acid
indication
Hyperammonemia
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 1h ago
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