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OPICAPONE
CAS NO.: 923287-50-7
Chemical Formula: C15H10Cl2N4O6
Molecular Weight: 413.2000
DMF&GMP status: Please contact us for more details.
Description:
Opicapone is a ring assembly and an oxadiazole.

Opicapone is a potent, reversible, and peripherally-acting third-generation inhibitor of catechol-o-methyltransferase (COMT), an enzyme involved in the breakdown of various catecholamines including dopamine. In June 2016, the European Commission granted a marketing authorization valid throughout the European Union for OPC, indicated as adjunct therapy to levodopa and decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations. In April 2020, the FDA approved the use of opicapone as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. Opicapone is marketed as, under the brand name Ongentys as once-daily oral capsules. Almost all individuals with Parkinson’s disease whom are treated with levodopa plus a dopa decarboxylase (DDC) inhibitor (eg carbidopa) will develop motor complications in time. The initial step in the management is changing the levodopa/DDC inhibitor dosage and the use of adjunct drugs. Various options include supplementing with a dopamine agonist, a monoamine oxidase B inhibitor (selegiline, rasagiline), a catechol-O-methyl transferase (COMT) inhibitor, or amantadine, or using a modified-release formulation of levodopa. The newest adjunctive option is opicapone. This drug is a peripherally selective reversible COMT inhibitor that offers the benefit of a duration of action exceeding 24h, allowing for once-daily administration. Opicapone demonstrates the lowest risk for cytotoxicity in comparison with other catechol-O-methyltransferase inhibitors.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
OPICAPONECAPSULE;ORAL25MGONGENTYSNEUROCRINE BIOSCIENCES INC
OPICAPONECAPSULE;ORAL50MGONGENTYSNEUROCRINE BIOSCIENCES INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
816879304/02/2029DSDPU-2811
852474607/14/2029U-2811
890709905/12/2027DS
955075907/26/2026U-2811 U-2817 U-2818
963095512/12/2032DSDPU-2811
974529010/10/2027DPU-2811
1007108503/31/2030DP
1035746805/27/2035U-2812
1058313003/31/2030U-2811
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 04/24/2025