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Ongentys · pharmadog

pharmadog
drugs
Ongentys

drug

patient view →

opicapone

Marketedupdated 2mo ago

by $AMRX Amneal Pharmaceuticals, Inc.

Approved

community read0 votes

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

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

ONGENTYS (OPICAPONE) — FDA approval

ONGENTYS (OPICAPONE) — FDA approval

ONGENTYS (OPICAPONE) — FDA approval

comments(0)

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no comments yet — first sniff?

Data sources

openFDA · ClinicalTrials.gov

last refreshed 1h ago

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Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

Patent cliff

source: FDA Orange Book

first barrier falls

Jul 26, 2026

19 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 100710853.7y
Mar 31, 2030formulationUS 100710853.7y
Mar 31, 2030method-of-use (U-3869)US 105831303.7y
Mar 31, 2030method-of-use (U-3869)US 105831303.7y
Jul 14, 2029method-of-use (U-3869)US 85247463.0y
Jul 14, 2029method-of-use (U-3869)US 85247463.0y
Apr 2, 2029compositionUS 81687932.7y
Apr 2, 2029compositionUS 81687932.7y
Oct 10, 2027formulationUS 97452901.3y
Oct 10, 2027formulationUS 97452901.3y
May 12, 2027compositionUS 8907099309d
May 12, 2027compositionUS 8907099309d
Jul 26, 2026method-of-use (U-3872)US 955075919d
Jul 26, 2026method-of-use (U-3872)US 955075919d

$AMRX17.25+0.58%

$AMRX17.25+0.58%

$AMRX17.25+0.58%

🐶 often sniffed alongside

top 3

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

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