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  1. pharmadog
  2. ›drugs
  3. ›Ongentys
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opicapone

Marketedupdated 5mo ago
by $AMRX Amneal Pharmaceuticals, Inc.
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugONGENTYS12 co-mentions · 3 sources
  • tagApproval12 co-mentions · 3 sources
  • tagSmall Molecule6 co-mentions · 3 sources

Small molecule drug with a maximum clinical stage of Approval, with an approval for parkinson disease.

indications

investigational
Parkinson's Disease

all catalysts(3)

approval · 3
Apr 24, 2020
approval
$AMRX20.50+3.69%
6y ago
ONGENTYS (OPICAPONE) — FDA approval
opicapone
→
Feb 7, 2025
approval
$AMRX20.50+3.69%
2y ago
ONGENTYS (OPICAPONE) — FDA approval
opicapone
→
Oct 10, 2025
approval
$AMRX20.50+3.69%
12mo ago
ONGENTYS (OPICAPONE) — FDA approval
opicapone
→

Trials studying opicapone

  • —REal-life ON PARKinson's - ITaly (REONPARK-IT)recruitingn=200
  • phase4OpiCapone Effect on Motor Fluctuations and pAiNcompletedn=144
  • phase4OpicApone Sleep dISordercompletedn=22
  • phase4eArly levoDopa With Opicapone in Parkinson's paTients wIth motOr fluctuatioNs.completedn=106
  • phase3Early ParkinSon wIth L-DOPA/DDCI and OpicapoNe (EPSILON Study)completedn=410
  • phase4A Study to Evaluate the add-on Efficacy and Safety of Opicapone 50 mg or an Extra Dose of L-DOPA 100 mg for the Treatment of Wearing-off in Patients With PDcompletedn=169

Patent cliff

source: FDA Orange Book
first barrier falls
May 12, 2027
224 days

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

patents (18)

  • Dec 12, 2032compositionUS 9630955
  • Dec 12, 2032compositionUS 9630955
  • Jan 11, 2032method-of-use (U-4038)US 12129247
  • Jan 11, 2032method-of-use (U-4038)US 12129247
  • Mar 31, 2030formulationUS 100710853.5y
  • Mar 31, 2030formulationUS 100710853.5y
  • Mar 31, 2030method-of-use (U-3869)US 105831303.5y
  • Mar 31, 2030method-of-use (U-3869)US 105831303.5y
  • Jul 14, 2029method-of-use (U-3869)US 85247462.8y
  • Jul 14, 2029method-of-use (U-3869)US 85247462.8y
  • Apr 2, 2029compositionUS 81687932.5y
  • Apr 2, 2029compositionUS 81687932.5y
  • Oct 10, 2027formulationUS 97452901.0y
  • Oct 10, 2027formulationUS 97452901.0y
  • May 12, 2027compositionUS 8907099224d
  • May 12, 2027compositionUS 8907099224d
  • Jul 26, 2026method-of-use (U-3872)US 9550759
  • Jul 26, 2026method-of-use (U-3872)US 9550759

News(0)

no news has mentioned this drug yet

brand
Ongentys
generic
opicapone [INN]
MOA
12.1 Mechanism of Action Opicapone is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT). COMT catalyzes the transfer of the methyl group of S-adenosyl-L-methionine to the phenolic group of substrates that contain a catechol structure. Physiological substrates of COMT include DOPA, catecholamines (dopamine, norepinephrine, and epinephrine), and their hydroxylated metabolites. When decarboxylation of levodopa is prevented by carbidopa, COMT becomes the major metabolizing enzyme for levodopa, catalyzing its metabolism to 3-methoxy-4-hydroxy-L-phenylalanine (3-OMD).
indication
Parkinson's Disease
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 2h ago
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