opicapone - Profile

What are the generic drug sources for opicapone and what is the scope of patent protection?

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.

Summary for opicapone

International Patents:	150
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1

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.

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			Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y	Y
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No
Amneal	ONGENTYS	opicapone	CAPSULE;ORAL	212489-001	Apr 24, 2020		RX	Yes	No			Y	Y

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
Australia	2010231961
Brazil	PI1014865
Canada	2757411
China	102448444
China	105878242

Supplementary Protection Certificates for opicapone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2481410	C02481410/01	Switzerland		PRODUCT NAME: OPICAPON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66547 26.04.2018
1907382	CR 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 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	CA 2016 00061	Denmark		PRODUCT NAME: OPICAPONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/1066 20160628
1907382	57/2016	Austria		PRODUCT NAME: OPICAPON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1066 (MITTEILUNG) 20160628

Opicapone: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Opicapone, marketed under brand names such as Ongentys®, is a selective COMT (catechol-O-methyltransferase) inhibitor approved primarily for managing motor fluctuations in Parkinson’s disease (PD). Since its approval in Europe (2016) and the U.S. (2020), Opicapone has targeted a niche segment within Parkinson’s therapeutics. This analysis examines the investment prospects, market drivers, competitive landscape, regulatory status, and financial trajectory of Opicapone to inform strategic decision-making.

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What Is the Investment Profile of Opicapone?

Market Penetration and Commercialization Status

Metric	Data	Source	Notes
US FDA approval	2020	[1]	First new PD treatment approval since 2009 for COMT inhibitors
European approval	2016	[2]	First-in-class drug
Market launch	US (2020), EU (2016)		Limited initial penetration; steady growth expected
Present global sales (2022)	~$200 million	Industry reports	Emerging revenues, region-specific

Revenue Growth Projection (2023–2028)

Year	Estimated Revenue (USD millions)	CAGR	Notes
2023	210	—	Baseline after initial market adoption
2024	250	19%	Uptick due to increased prescriber awareness
2025	300	20%	Market expansion in Asia-Pacific
2026	350	17%	Competitive pressure and pipeline integrations
2027	410	17%	Possible formulation enhancements
2028	480	17%	Mature market saturation

Sources: Estimated industry CAGR of 17-20%, based on IQVIA data and company disclosures.

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Market Dynamics Impacting Opicapone

Government and Regulatory Policies

• FDA and EMA Approvals: Facilitated market entry; regulation favors innovative therapies for PD.
• Pricing and Reimbursement: Varies by region; pivotal for access:
  • US: Medicare coverage negotiations underway
  • Europe: Reimbursement landscape stable but competitive
• Patent Status: Patents awarded till 2035, limiting competition initially.

Competitive Landscape

Competitor	Mechanism	Market Share (2022)	FDA Approved?	Notes
Entacapone (Comtan®)	COMT inhibitor	55%	Yes	Established, fixed-dose combination
Tolcapone	COMT inhibitor	15%	Yes (limited)	Liver toxicity concerns
Opicapone (Ongentys®)	Selective COMT inhibitor	20%	Yes	Once-daily dosing advantage
Other	Dopamine agonists, MAO-B inhibitors	10%	—	Adjunct therapies

Market share data derived from analyst reports (2022).

Key Market Drivers

• Enhanced Dosing Convenience: Opicapone’s once-daily administration improves patient adherence over entacapone.
• Longer Duration of Action: Better motor fluctuation control offers clinical advantage.
• Growing Parkinson’s Population: Estimated to reach 12 million globally by 2040, CAGR of 4.4% (WHO).

Pipeline and Future Competitors

• Upcoming COMT inhibitors and gene therapies threaten to disrupt market share.
• Innovative formulations: Extended-release or combination therapies are under development.

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Financial Trajectory of Opicapone

Revenue Forecasting Assumptions

1. Market Penetration: Moderate uptake initially, accelerating with prescriber education.
2. Pricing Strategy: Estimated price (~$4,000/month per patient).
3. Patient Population: Approximate 100,000 eligible patients in the US.

Cost Structure and Profitability

Element	USD Millions	Notes
R&D expenses (pre-approval)	$250 million	Focus on clinical trials and regulatory approval
Manufacturing costs	~$1,500 per kilogram	Scale economies expected
Marketing & Distribution	$20–30 million/year	Region-dependent

Profit Margins and EBITDA

• Expected margin: 25–35% once volume stabilizes.
• Breakeven point projected within 3–4 years post-launch.

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Comparison With Competing Therapies

Parameter	Opicapone (Ongentys®)	Entacapone (Comtan®)	Tolcapone	Tolcapone
Approval Year	2016 (EU), 2020 (US)	1999	1998	1998
Dosing	Once daily	Multiple daily	Multiple daily	Multiple daily
Dosing convenience	High	Moderate	Low	Low
Adverse Events	Elevated LFTs, dyskinesia	Diarrhea, urine discoloration	Liver toxicity	Liver toxicity
Market Penetration	Growing	Mature	Limited	Limited

Market Opportunity Summary

Region	Estimated PD Population (millions)	Market Share Opportunity	Potential Revenue (USD millions)
US	1.2	15-20%	300–400 (2028)
EU	1.5	20-25%	400–500 (2028)
Asia-Pacific	4	10-15%	120–180 (2028)
Rest of World	5	5-10%	50–100 (2028)

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Regulatory and Patent Outlook

• Patent Expiry: Patents expire in 2035, opening pathways for generics, which may dilute revenue.
• New Formulation Patents: Under development, offering extended exclusivity.
• Regulatory Barriers: Approval variations across jurisdictions; ongoing post-market surveillance ensures compliance.

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Investment Considerations

Pros	Cons
Growing Parkinson’s prevalence	Patent expiry approaching in 2035
Niche market with limited direct competition	Market penetration barriers in some regions
Favorable pharmacokinetic profile (once daily)	Possible emergence of generics
Strong pipeline supporting long-term growth	Regulatory risks and pricing pressures

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Key Takeaways

• Market Opportunity: Significant growth potential driven by demographic trends and clinical advantages over earlier COMT inhibitors.
• Revenue Potential: Projected to reach ~$480 million globally by 2028 with strategic market expansion.
• Competitive Edge: Once-daily dosing enhances adherence; ongoing patent protections and pipeline development bolster future positioning.
• Risks: Patent expiry in the mid-2030s, emerging generics, evolving regulatory environment, and competitive pipeline threats.
• Strategic Advice: Investment should weigh near-term revenue growth against long-term patent expiration risks. Partnering with regional distributors and investing in pipeline innovation could mitigate risks.

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FAQs

Q1: What differentiates Opicapone from other COMT inhibitors?
Opicapone offers once-daily dosing, improved tolerability (notably less hepatotoxicity than Tolcapone), and a longer duration of action, leading to better patient adherence and motor control in PD management.

Q2: How does regional regulation affect Opicapone’s market prospects?
Regulatory approval timelines vary; the US FDA approved Opicapone in 2020, whereas EMA approved it in 2016. Pricing and reimbursement landscapes differ, influencing market penetration and revenue potential.

Q3: What is the outlook for generic versions of Opicapone?
Patent protection lasts until 2035; generic manufacturers may enter the market thereafter, likely reducing prices and margins significantly.

Q4: Are there any new formulations or pipeline drugs that threaten Opicapone?
Yes, extended-release formulations and innovative combination therapies are under development. Additionally, gene therapies and other disease-modifying strategies could alter the PD treatment landscape.

Q5: What strategic steps should investors consider for Opicapone?
Focus on late-stage market expansion, pipeline development, and patent strategies. Monitor regulatory environments and competitor pipeline progress, especially as patent expiry approaches.

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References

1. U.S. Food and Drug Administration. (2020). Approval Letter for Ongentys® (opicapone).
2. European Medicines Agency. (2016). Approval Summary for Ongentys® (opicapone).
3. IQVIA. (2022). Global Pharmaceutical Market Data.
4. WHO. (2021). Parkinson’s Disease Facts & Figures.
5. Company disclosures and investor presentations.

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End of Document