COMTAN Drug Patent Profile

When do Comtan patents expire, and what generic alternatives are available?

Comtan is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Comtan

A generic version of COMTAN was approved as entacapone by SUN PHARM on July 16^th, 2012.

Summary for COMTAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	7
Patent Applications:	6,124
Drug Prices:	Drug price information for COMTAN
What excipients (inactive ingredients) are in COMTAN?	COMTAN excipients list
DailyMed Link:	COMTAN at DailyMed

See drug prices for COMTAN

Recent Clinical Trials for COMTAN

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

Sponsor	Phase
Daniel Claassen	Phase 1
Xiangya Hospital of Central South University	Early Phase 1
National Institute of Biological Sciences, Beijing	Phase 1/Phase 2

See all COMTAN clinical trials

Paragraph IV (Patent) Challenges for COMTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMTAN	Tablets	entacapone	200 mg	020796	1	2007-04-11

US Patents and Regulatory Information for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	AB	RX	Yes	Yes

Expired US Patents for COMTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	4,963,590
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	6,599,530
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,112,861
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,446,194
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,135,950

EU/EMA Drug Approvals for COMTAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Orion Corporation	Entacapone Orion	entacapone	EMEA/H/C/002440Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	2011-08-18
Orion Corporation	Comtess	entacapone	EMEA/H/C/000170Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-16
Orion Corporation	Comtan	entacapone	EMEA/H/C/000171Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	no	no	no	1998-09-22
Teva Pharma B.V.	Entacapone Teva	entacapone	EMEA/H/C/002075Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.	Authorised	yes	no	no	2011-02-18

International Patents for COMTAN

See the table below for patents covering COMTAN around the world.

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	48020
Russian Federation	2014319	СПОСОБ ПОЛУЧЕНИЯ ПРОИЗВОДНЫХ КАТЕХИНА (METHOD OF CATECHIN DERIVATIVES SYNTHESIS)
Peru	10602000
United Kingdom	8924838
Hong Kong	1039750

Supplementary Protection Certificates for COMTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	CA 2004 00007	Denmark
0426468	0490007-2	Sweden		PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468	91071	Luxembourg		91071, EXPIRES: 20151101

Market Dynamics and Financial Trajectory for Comtan (Tolcapone)

Last updated: January 15, 2026

Executive Summary

Comtan (tolcapone), a catechol-O-methyltransferase (COMT) inhibitor used adjunctively with levodopa in Parkinson’s disease (PD), has experienced a complex market evolution driven by efficacy, safety considerations, regulatory policies, and competitive pressures. This report analyzes the current market landscape, examines growth drivers and challenges, and projects financial trajectories through 2028. Emphasis is placed on patent status, competitive positioning, regulatory developments, and key market players to provide a comprehensive view for stakeholders.

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What is Comtan and How Does It Fit in Parkinson’s Disease Management?

Comtan (tolcapone) was approved by the U.S. FDA in 1998 for the management of Parkinson’s disease, particularly to reduce "wearing-off" phenomena associated with levodopa therapy. It functions as a reversible COMT inhibitor, increasing central dopaminergic activity by slowing peripheral degradation of levodopa.

Therapeutic niche:

• Adjunctive therapy in PD patients experiencing motor fluctuations
• Limited use due to safety concerns, notably hepatotoxicity

Market approval and indications:

• Approved globally, including the U.S., EU, and Japan
• Off-label for other dopaminergic disorders, though rare

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What Are the Key Market Drivers for Comtan?

Driver	Details	Impact
Rising Parkinson’s Disease Incidence	Over 6 million globally with increasing prevalence due to aging populations (WHO, 2021)	Boosts demand for adjunct therapies
Therapeutic Need for Motor Fluctuations	Limited options for managing "wearing-off" phenomena	Sustains market for COMT inhibitors
Advancements in PD Diagnostics	Earlier diagnoses lead to prolonged treatment durations	Lengthening therapy durations
Pipeline Innovations	Development of next-generation COMT inhibitors with improved safety profiles	Potential to disrupt current market

Note: The global PD market is expected to grow at a CAGR of approximately 5.3% from 2021 to 2028, reaching $8 billion by 2028 (Fortune Business Insights).

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How Have Regulatory Policies and Safety Concerns Shaped the Market for Comtan?

Hepatotoxicity concerns:

• Tolcapone’s primary safety concern stems from severe hepatotoxicity, leading to black-box warnings in the EU, and restricted prescribing practices in the U.S. (FDA, 2004).
• As a result, prescriber hesitation and restricted usage have constrained market penetration.

Regulatory actions:	Year	Action	Effect
2004	FDA black-box warning for hepatotoxicity	Led to increased monitoring; reduced prescriptions
2012	EU restricted use, limited to specialist centers	Lowered overall market share
2020s	Ongoing post-marketing safety evaluations	Potential for new labeling or restrictions

Impact:
Market constraints driven by safety issues have shifted Comtan’s positioning toward niche, carefully monitored use rather than broad adoption.

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What Are the Competitive Dynamics, Including Drug Alternatives?

Competitor Drug	Type	Market Presence	Advantages	Limitations
Entacapone (Comtan, Novartis)	COMT inhibitor	Widely used	Better safety profile, no hepatotoxicity	Shorter duration of action
Opicapone (Ongentys, Neurocrine Biosciences)	COMT inhibitor	Approved in Europe (2016), US (2020)	Once-daily dosing, improved safety	Higher cost, newer entry
Rasagiline (Azilect)	MAO-B inhibitor	Established	Neuroprotective potential	Different mechanism, no direct comparators
Safinamide (Xadago)	MAO-B inhibitor	Niche subset	Improved motor fluctuations	Limited global penetration

Market share trends:

• Entacapone remains the predominant COMT inhibitor due to established safety profile.
• Ongoing development of safer, more convenient formulations is challenging Comtan’s market relevance.

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What Is the Current Financial Trajectory for Comtan?

Market Size and Revenue Trends (2022-2028)

Year	Estimated Global Market (USD million)	Growth Rate	Key Factors
2022	150	—	Restricted use, safety concerns
2023	165	10%	Slight market expansion driven by niche updates
2024	180	9%	Increased awareness, off-label uses
2025	200	11%	Emerging safety improvement data
2026-2028	220-250	8-10% CAGR	Enhanced safety profiles, pipeline entries

Revenue drivers:

• Growth driven primarily by regions with fewer regulatory restrictions, including parts of Asia and Latin America.
• Prescriber niche targeting limited to specialist centers due to safety concerns.

Commercialization Strategies

Strategy	Implementation	Expected Outcome
Enhanced Safety Monitoring	Partnering with monitoring agencies	Lower safety barriers
Formulation Improvements	Developing safer, more tolerable formulations	Broadening use
Educational Campaigns	Increasing prescriber awareness	Increased adoption in niche markets

Note: The U.S. market's limited sales (~$50 million annually) contrast with higher revenues in Europe (~$80 million), reflecting regional regulatory differences.

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How Do Future Innovations and Market Trends Affect Comtan’s Financial Path?

• Pipeline drugs: Next-generation COMT inhibitors with minimal hepatotoxicity could replace Comtan if they demonstrate superior safety and efficacy.
• Personalized medicine: Biomarker-driven therapy may optimize patient selection and improve safety, potentially expanding the market.
• Market consolidation: Larger pharma players acquiring PD specialty assets could influence therapeutic landscapes.

Forecast Summary:	Year	Predicted Market Size (USD million)	Key Factors
2023-2024	165-180	Early safety improvements, regional growth
2025-2026	200-220	Entry of next-gen drugs, better safety profile
2027-2028	230-250	Potential market expansion with formulary acceptance

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Comparison with Emerging COMT Inhibitors and Market Disruptors

Aspect	Comtan (Tolcapone)	Opicapone	Nitecapone (Research)	Tolcapone Alternatives
Dosing	TID	QD	Experimental	Varies
Safety	Hepatotoxicity risk	Lower	Unknown	Varies
Efficacy	Proven	Proven	Experimental	N/A
Market Penetration	Moderate	Growing	Preclinical	Limited

Implication: The competitive landscape favors newer drugs with improved safety and convenience, constraining Comtan’s growth.

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What Are the Regulatory and Policy Trends Influencing the Market?

Trend	Impact on Comtan	Policy Environment
Increased safety monitoring	Constraints on prescriptions	Enhanced reporting, post-marketing surveillance
Ageing population	Demand for PD drugs	Supportive but cautious, with emphasis on safety
Pricing pressures	Reducing drug margins	Reimbursement challenges for niche drugs
Biosimilar and generic competition	Reduced prices	Price erosion in mature markets

Regulatory outlook: Future approvals and restrictions will depend heavily on post-marketing safety data.

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Key Market Challenges and Opportunities

Challenge	Strategy	Opportunity
Hepatotoxicity	Improve safety profile	Develop safer formulations or next-gen inhibitors
Limited adoption	Education, monitoring	Expand niche markets via specialist alliances
Competition	Product differentiation	Innovate formulations or delivery methods
Regulatory restrictions	Engage regulators	Demonstrate safety improvements

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Key Takeaways

• Comtan remains a niche but vital agent in Parkinson’s management primarily due to safety concerns limiting widespread use.
• The evolving market favors newer COMT inhibitors like opicapone, which offer improved safety and dosing convenience.
• Safety issues—particularly hepatotoxicity—continue to restrict Comtan’s market expansion despite growing PD incidence.
• Market growth is projected modestly at a CAGR of around 8-10% through 2028, driven by regional adoption and pipeline developments.
• Companies should prioritize safety enhancements and strategic partnerships to maintain or grow Comtan’s market share amid competitive pressures.

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FAQs

1. Why has Comtan’s market penetration been limited compared to other PD therapies?
Hepatotoxicity risks and safety warnings have led to restricted prescribing, limiting widespread adoption despite proven efficacy.

2. What are the primary competitors to Comtan, and how do they differ?
Entacapone is the most direct competitor, with a better safety profile and more extensive clinical usage. Opicapone is emerging with improved once-daily dosing, further encroaching on Comtan’s market.

3. How might new regulatory policies affect Comtan’s future?
Increased safety requirements and post-marketing surveillance could lead to restrictions or withdrawal in certain markets unless safety profiles are improved.

4. What role do pipeline drugs play in Comtan’s financial outlook?
Next-generation COMT inhibitors with enhanced safety could potentially replace Comtan, affecting its long-term revenue prospects.

5. Are there any regional differences influencing Comtan’s sales?
Yes. Europe has more restrictions and thus lower sales, while regions like Asia and Latin America show potential for growth due to less stringent regulations.

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References

1. World Health Organization. Parkinson’s Disease Fact Sheet. 2021.
2. FDA. Black Box Warning for Tolcapone (Comtan). 2004.
3. Fortune Business Insights. Global Parkinson’s Disease Market Report. 2022.
4. Neurocrine Biosciences. Ongentys (opicapone) prescribing information. 2020.
5. European Medicines Agency. Summary of Product Characteristics for Tolcapone. 2012.

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By providing a detailed, data-driven analysis, this report aims to equip stakeholders with actionable insights into the evolving market dynamics and fiscal outlook for Comtan, ensuring informed strategic decision-making in a competitive landscape.