Prescription medicine
Opicapone Brand names: Ongentys
Opicapone (Ongentys) is a prescription medicine with an FDA approval on record since 2020. No generic is listed; pharmacies paid $24.67 per Ongentys 25 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the opicapone FDA label on DailyMed (effective October 15, 2025, Amneal Pharmaceuticals LLC); the NDA 212489 record on Drugs@FDA; every opicapone label on DailyMed.
Highlights of the record
FDA label of October 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Forms and strengths
- 25 mg
- 50 mg
Capsule.
On the market
- Earliest approval on file
- April 24, 2020 Ongentys, Amneal; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 12, 2032 Ongentys capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $24.67 per capsule Ongentys 25 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,261 through July 30, 2026
What is opicapone used for?
From the label: indications and usageONGENTYS is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes. ONGENTYS is a catechol-O-methyltransferase (COMT) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Conditions named in the indications of opicapone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Catechol-O-Methyltransferase Inhibitor.
Source: FDA drug label (ONGENTYS), Amneal Pharmaceuticals LLC, effective October 15, 2025 (SPL set a511a531-112e-43f8-a43f-5334b0efe979), via openFDA; the full label on DailyMed
What does the patient leaflet for opicapone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking ONGENTYS?Do not drive, operate machinery, or do other dangerous activities until you know how ONGENTYS affects you.
From the patient leaflet: How should I store ONGENTYS?Store ONGENTYS at a temperature below 86°F (30°C). Keep ONGENTYS and all medicines out of the reach of children.
Source: FDA drug label (ONGENTYS), Amneal Pharmaceuticals LLC, effective October 15, 2025 (SPL set a511a531-112e-43f8-a43f-5334b0efe979), via openFDA; the full label on DailyMed
Is there a generic for opicapone (Ongentys)?
No generic opicapone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 9 patents for Ongentys capsules: the compound patent runs to December 12, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for opicapone (Ongentys)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $24.67 per Ongentys 25 mg capsule, up 4% from $23.60 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Ongentys 25 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Ongentys 25 mg capsule | Brand | $24.67 per capsule | $740.04 | +4% |
| Ongentys 50 mg capsule | Brand | $24.76 per capsule | $742.81 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the opicapone label say about other medicines?
The opicapone label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Dobutamine | warnings and precautions | … of ONGENTYS and drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, and dobutamine), regardless of the route of administration (including inhalation). |
| Epinephrine | warnings and precautions | Effects with Concomitant Use of Drugs Metabol ized by Catechol-O-Methyltransferase (COMT) Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, and … |
| Isocarboxazid | drug interactions | DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. |
| Isoproterenol | warnings and precautions | Effects with Concomitant Use of Drugs Metabol ized by Catechol-O-Methyltransferase (COMT) Possible arrhythmias, increased heart rate, and excessive changes in blood pressure may occur with concomitant use of ONGENTYS and drugs metabolized by COMT (e.g., isoproterenol, epinephrine, norepinephrine, dopamine, and … |
| Levodopa | warnings and precautions | May cause or exacerbate dyskinesia; consider levodopa or dopaminergic medication dose reduction. ( 5.4 ) Hallucinations and Psychosis: |
| Phenelzine | drug interactions | DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. |
| Tranylcypromine | drug interactions | DRUG INTERACTIONS 7.1 Non-Selective Monoamine Oxidase (MAO) Inhibitors Both ONGENTYS and non-selective MAO inhibitors (e.g., phenelzine, isocarboxazid, and tranylcypromine) inhibit catecholamine metabolism, leading to increased levels of catecholamines. |
Source: FDA drug label (ONGENTYS), Amneal Pharmaceuticals LLC, effective October 15, 2025 (SPL set a511a531-112e-43f8-a43f-5334b0efe979), via openFDA; the full label on DailyMed
What do FAERS reports show for opicapone?
The FDA Adverse Event Reporting System holds 2,261 reports that list opicapone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 235 are coded as a death and 929 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as opicapone?
13 other medicines are given the same way (oral) and in the same FDA class as opicapone or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Carbidopa and entacapone and levodopa | Parkinson's disease | 4 labelers | $0.695 per tablet 25-100-200 mg tablet | No current entry |
| Entacapone | Parkinson's disease | 11 labelers | $0.325 per tablet 200 mg tablet | No current entry |
| Tolcapone | Parkinson's disease | 1 labeler | n/a | No current entry |
| Ropinirole | Parkinson's disease | 27 labelers | $0.046 per tablet 0.25 mg tablet | No current entry |
| Pramipexole | Parkinson's disease | 22 labelers | $0.0452 per tablet 0.25 mg tablet | No current entry |
| Carbidopa and levodopa | Parkinson's disease | 33 labelers | $0.0759 per tablet 25-100 tablet | No current entry |
| Benztropine | Parkinson's disease | 19 labelers | $0.0753 per tablet 1 mg tablet | A presentation being discontinued |
| Rasagiline | Parkinson's disease | 14 labelers | $0.521 per tablet 0.5 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to opicapone
- 13 medicines for the same use
- Other catechol-o-methyltransferase inhibitors
- the pharmacologic class, with prices and generics
- Opicapone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other