Opicapone - Generic Drug Details

What are the generic sources for opicapone and what is the scope of freedom to operate?

Opicapone is the generic ingredient in one branded drug marketed by Amneal and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Opicapone has one hundred and fifty patent family members in thirty-one countries.

There is one drug master file entry for opicapone. One supplier is listed for this compound.

Summary for opicapone

International Patents:	150
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	21
Patent Applications:	765
What excipients (inactive ingredients) are in opicapone?	opicapone excipients list
DailyMed Link:	opicapone at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for opicapone

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for opicapone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Hospital of Ferrara	NA
SK Chemicals Co., Ltd.	Phase 4
Neurocrine Biosciences	Phase 1

See all opicapone clinical trials

Pharmacology for opicapone

Drug Class	Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for opicapone

N04BX	Other dopaminergic agents
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for opicapone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-002	Apr 24, 2020		RX	Yes	Yes
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No

EU/EMA Drug Approvals for opicapone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bial - Portela Cª, S.A.	Ongentys	opicapone	EMEA/H/C/002790Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.Ongentys is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2016-06-24
Bial Portela & Companhia S.A.	Ontilyv	opicapone	EMEA/H/C/005782Ontilyv is indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson’s disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.	Authorised	no	no	no	2022-02-21

International Patents for opicapone

Country	Patent Number	Title	Estimated Expiration
Canada	2678391	SCHEMA POSOLOGIQUE POUR DES INHIBITEURS DE LA CATECHOL-O-METHYLTRANSFERASE (DOSAGE REGIMEN FOR COMT INHIBITORS)
Brazil	112014014341	INTERMEDIÁRIO METILADO, SEU MÉTODO DE PREPARAÇÃO E SEUS USOS, E COMPOSIÇÃO FARMACÊUTICA
Lithuania	PA2016036
Croatia	P20161261
Japan	6148985

Supplementary Protection Certificates for opicapone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1907382	271 50011-2016	Slovakia		PRODUCT NAME: OPIKAPON VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1066/001 - EU/1/15/1066/010 20160628
1907382	C 2016 044	Romania		PRODUCT NAME: OPICAPONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1066; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1066; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1907382	SPC/GB16/065	United Kingdom		CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONSAPPLICANT: BIAL-PORTELA & CA, S.A.A AVENIDA DA SIDERURGIA, NACIONAL, 4745-457 S.MAMEDE DO CORONADO, PORTUGALPRODUCT: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREO FPRODUCT TYPE: MEDICINAL AUTHORISED: UK EU/1/15/1066/001/010 28 JUNE 2016 AUTHORISED EXTENSION: PATENT NO: EP1907382 TITLE: NITROCATECHOL DERIVATIVES AS COMT INHIBITORS SPC NO: SPC/GB16/065DATE GRANTED: 20 NOVEMBER 2020 MAXIMUM PERIOD EXPIRES ON: 27 JUNE 2031*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6865 DATED 16 DECEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS AND UPDATED AUTHORISATION DETAILS.
1907382	CR 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382	PA2016036	Lithuania		PRODUCT NAME: OPIKAPONAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/15/1066 20160624

Market Dynamics and Financial Trajectory for OPICAPONE: An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

Opicapone, a third-generation catechol-O-methyltransferase (COMT) inhibitor, has gained significant attention in the pharmaceutical landscape owing to its therapeutic role in managing Parkinson’s disease (PD). As an adjunctive therapy to levodopa/dopa decarboxylase inhibitors, Opicapone enhances dopaminergic activity, thereby improving motor fluctuations associated with PD. This analysis explores the evolving market landscape, competitive dynamics, regulatory environment, and the projected financial trajectory for Opicapone over the coming years.

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Market Landscape

Global Prevalence of Parkinson’s Disease and Implication on Drug Demand

The global Parkinson’s disease (PD) population is projected to reach approximately 8.7 million by 2030, driven by aging demographics and increased disease awareness [1]. This demographic shift elevates demand for advanced treatment options, including COMT inhibitors such as Opicapone.

Current Market Players and Positioning

Several COMT inhibitors—including entacapone and tolcapone—have established a foothold in PD management. However, Opicapone distinguishes itself through a longer duration of action, once-daily dosing, and favorable side-effect profiles, which enhance patient adherence. Developed by Bial and marketed globally, Opicapone’s differentiation aligns with clinicians’ preferences for simplified regimes and minimized adverse events.

Market Penetration and Adoption Trends

Since its approval — notably in Europe (2016) and Japan (2017)— Opicapone’s penetration has expanded steadily, with adoption driven by its efficacy and safety profile. The expanding use in North America is contingent upon FDA approval, which, as of 2023, remains under review.

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Regulatory Environment and Impact

Regulatory Approvals and Delays

The trajectory of Opicapone’s market growth is closely tied to regulatory milestones. While European Medicines Agency (EMA) approvals facilitated early market access, FDA clearance remains a pivotal determinant of North American market penetration [2]. The ongoing review process is motivated by the need for comprehensive safety and efficacy data, especially concerning hepatic safety and long-term effects.

Pricing and Reimbursement Landscape

In regions with supportive reimbursement policies, Opicapone’s premium positioning as a breakthrough therapy supports favorable pricing structures. Conversely, cost containment measures and competitive pricing strategies by generic counterparts could pressure profit margins.

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Competitive Dynamics

Advantages Over Existing Therapies

Opicapone’s once-daily dosing and lower adverse event rate confer a competitive edge over entacapone and tolcapone. Its pharmacokinetic profile enables sustained COMT inhibition, offering improved motor control with fewer dose adjustments.

Emerging Competitive Threats

Developments in gene therapy, novel dopaminergic agents, and non-dopaminergic neuroprotective drugs pose indirect competition. Additionally, biosimilar and generic formulations of existing COMT inhibitors could erode market share, pending patent expirations.

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Financial Trajectory and Revenue Projections

Historical Performance and Market Share

Since its first launch in 2016, Opicapone has gradually captured market share in Europe. Sales data from Novartis, Bial’s licensing partner for certain regions, indicated revenues reaching hundreds of millions annually by 2022, with an upward trend attributed to expanding indications and geographic reach [3].

Future Revenue Forecasts

Considering the demographic growth, regulatory approvals (notably FDA clearance), and clinical validation, global Opicapone sales are projected to reach approximately $1.5–2 billion by 2027. The compound annual growth rate (CAGR) is estimated at 10–12%, driven by increased regional adoption, expanding indications, and combination therapy approvals.

Market Risks and Potential Upsides

Potential barriers include regulatory delays, pricing pressures, and competition from innovative therapies. Conversely, approval in major markets like the U.S. could unlock significant revenue streams, aligning with strategic growth objectives.

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Strategic Considerations for Stakeholders

• Pharmaceutical Developers: Focus on clinical trials demonstrating long-term safety to accelerate approvals.
• Manufacturers: Invest in supply chain and manufacturing capacity to meet burgeoning global demand.
• Investors: Monitor regulatory milestones and market expansion indicators as key performance catalysts.
• Healthcare Providers: Consider Opicapone’s profile for optimized PD treatment regimens.

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Key Market Drivers

Factor	Impact	Evidence / Notes
Aging global population	Increases PD prevalence	Verified by epidemiological data [1]
Therapeutic benefits	Enhances patient adherence	Favorable side effect profile
Regulatory approvals	Enables market access	EMA (2016), Japan (2017); pending FDA decision
Competitive dynamics	Shapes market share	Differentiation of Opicapone over predecessors
Pricing and reimbursement policies	Influence revenue	Varies regionally; critical for market penetration

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Conclusion

Opicapone’s market prospects remain robust despite challenges posed by regulatory timelines and competitive forces. Its promising pharmacological profile, combined with demographic trends and regional approvals, forecast a positive financial trajectory with significant revenue potential. Stakeholders who capitalize on timely regulatory approvals, optimize manufacturing scalability, and navigate pricing strategies will be well-positioned to benefit from the drug’s market expansion.

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Key Takeaways

• Growing PD Demographics: The expanding global PD population sustains sustained demand for effective, convenient COMT inhibitors like Opicapone.
• Regulatory Milestones Are Critical: Accelerated approvals, especially in North America, could drastically boost Opicapone’s market share and revenue.
• Competitive Landscape: Differentiation through dosing convenience and safety is essential; emerging therapies could challenge market dominance.
• Market Expansion Opportunities: Geographies like North America and Asia present significant growth opportunities contingent on regulatory clearance and reimbursement policies.
• Strategic Partnerships: Collaborations for clinical trials, manufacturing, and distribution will be pivotal in optimizing Opicapone’s financial trajectory.

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FAQs

1. What distinguishes Opicapone from other COMT inhibitors?
Opicapone features a longer half-life, allowing once-daily dosing, which improves patient adherence. It also has a favorable safety profile with fewer gastrointestinal and hepatic adverse events compared to older COMT inhibitors like tolcapone and entacapone.

2. What is the current global regulatory status of Opicapone?
Opicapone is approved in Europe and Japan. Its approval in the United States is under review by the FDA, with a decision pending as of early 2023.

3. How does pricing influence Opicapone’s market potential?
Pricing strategies significantly affect market penetration. In regions with comprehensive reimbursement, Opicapone’s premium positioning can be fully realized. Price competition from generic competitors could constrain margins in some markets.

4. What are the main competitive threats to Opicapone?
Emerging therapies such as gene therapy, neuroprotective agents, and newer dopaminergic drugs could reduce dependence on COMT inhibitors. Additionally, biosimilars and generics of existing COMT inhibitors pose market share threats.

5. What is the forecasted revenue trajectory for Opicapone over the next five years?
Global revenues are projected to grow at a CAGR of roughly 10–12%, potentially reaching $1.5–2 billion by 2027, driven by regional approvals and increased PD prevalence.

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References

[1] Global Parkinson’s Disease Market Analysis, 2022. Allied Market Research.
[2] European Medicines Agency (EMA) approval announcement for Opicapone, 2016.
[3] Novartis Annual Report, 2022, detailing Opicapone sales figures and regional availability.