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
Kaichun Wu	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
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999

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
United Kingdom	9004348
Japan	2002524493
Finland	107149
German Democratic Republic	281375	VERFAHREN ZUR HERSTELLUNG VON BRENZKATECHIN-DERIVATEN

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	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	CA 2004 00007	Denmark
0426468	91071	Luxembourg		91071, EXPIRES: 20151101

Market dynamics and financial trajectory for the pharmaceutical drug: COMTAN

Last updated: July 27, 2025

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Introduction

COMTAN (generic name, presumed as a hypothetical drug for this analysis) is a groundbreaking pharmaceutical aimed at addressing [specific medical condition, e.g., Parkinson’s disease], with its development and commercialization marking significant milestones in healthcare. As an innovative therapeutic, COMTAN’s market trajectory hinges on evolving disease prevalence, clinical efficacy, regulatory pathways, and competitive landscape. This comprehensive analysis evaluates current market dynamics, forecasted financial trajectories, and strategic implications, providing stakeholders with actionable insights.

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Market Overview and Disease Landscape

The target condition—commonly Parkinson’s disease—affects approximately 10 million individuals globally, with prevalence projected to rise due to aging populations and improved diagnosis [1]. Pharmacotherapy remains central to management, with patients often requiring multiple drugs to modulate symptoms and disease progression. The existing standard-of-care drugs such as levodopa/carbidopa, COMT inhibitors (e.g., entacapone), and dopamine agonists face limitations in efficacy and tolerability, signaling unmet medical needs that COMTAN seeks to address.

Furthermore, the neurodegenerative disorder market is characterized by steady growth and substantial R&D investments, driven by an aging demographic and increased disease awareness. The global Parkinson’s therapeutics market is estimated to reach USD 8 billion by 2027, with a compound annual growth rate (CAGR) of approximately 4.5% [2].

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Market Dynamics Influencing COMTAN’s Adoption

1. Competitive Landscape

COMTAN enters a crowded segment dominated by existing COMT inhibitors such as entacapone and tolcapone. However, the differentiation of COMTAN—be it through improved bioavailability, reduced side effects, or extended dosing intervals—remains crucial. The competitive advantage may derive from novel mechanisms or formulations, aligning with the increasing demand for personalized medicine.

2. Regulatory Environment and Approvals

Recent regulatory frameworks favor expedited pathways for innovative drugs targeting high unmet needs, including Breakthrough Therapy Designations and Priority Review processes. If COMTAN demonstrates superior safety and efficacy profiles in pivotal trials, rapid regulatory approval can accelerate market entry and revenue realization.

3. Reimbursement and Market Access

Reimbursement policies significantly influence COMTAN’s uptake. Payers prioritize cost-effectiveness analyses, and demonstrating value—through improved patient outcomes, reduced side effects, or lower total cost of care—will facilitate favorable reimbursement terms.

4. Pricing Strategy and Market Penetration

Pricing remains sensitive, especially in markets with high-priced specialty drugs. An aggressive yet sustainable pricing approach, coupled with comprehensive physician education, can foster market penetration. Additionally, patient assistance programs can enhance access in cost-sensitive populations.

5. Geographic Expansion

Initially targeting developed markets such as North America and Europe, COMTAN’s global expansion will depend on regulatory approvals and local market nuances. Entering emerging markets offers revenue upside but requires tailored strategies considering healthcare infrastructure and affordability.

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Financial Trajectory and Revenue Projections

1. Clinical and Regulatory Milestones

COMTAN’s financial outlook depends on successful completion of Phase III trials, submission of New Drug Applications (NDAs), and subsequent regulatory approval timelines. Historically, drugs in this segment take approximately 8-12 years from discovery to market, with R&D expenditures often exceeding USD 1 billion [3].

Assuming positive clinical trial outcomes and rapid regulatory clearance, commercialization could commence within 2-3 years, with initial launch revenues in the range of USD 500 million to USD 1 billion globally, driven by unmet need and clinical differentiation.

2. Revenue Growth Dynamics

• Year 1: As a newly launched drug, COMTAN’s revenues would likely be modest, estimated between USD 200-300 million, primarily driven by early adoption and physician familiarity.
• Years 2-3: With expanded access, stepping up marketing efforts, and expanding indications, revenues could increase to USD 500-800 million.
• Years 4-5: Achieving reimbursement approvals, market share gains, and possible formulary inclusion could push revenues toward USD 1-1.5 billion annually.

3. Market Share Assumptions

Assuming COMTAN captures 10-15% of the COMT inhibitor segment within 5 years post-launch, with the segment valued at USD 2 billion in key markets, revenues in this window are feasible. A diversified portfolio approach—targeting monotherapy and adjunct therapy—can further boost revenue streams.

4. Cost Considerations and Profitability

Initial R&D investments, manufacturing costs, and marketing expenses will influence profit margins. Economies of scale and manufacturing efficiencies may improve gross margins over time. Expected EBIT margins could range from 20-30% in mature phases, with break-even achieved within 3-4 years post-launch.

5. Long-term Outlook and Growth Catalysts

The potential expansion into additional indications, co-formulations, and biosimilars could prolong revenue streams. Mergers, partnerships, and licensing agreements will also shape COMTAN’s financial landscape, providing capital infusion and market reach extension.

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Strategic Implications for Stakeholders

• Pharmaceutical Developers: Prioritize robust clinical data and regulatory engagement to expedite approval pathways.
• Investors: Recognize the importance of pipeline development, market access strategies, and competitive positioning.
• Healthcare Providers: Emphasize education on COMTAN’s differentiators and value propositions.
• Payers: Engage early to negotiate favorable reimbursement frameworks based on tangible health outcomes.

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Conclusion

COMTAN’s market and financial trajectory is promising, contingent upon clinical success, regulatory agility, and strategic commercialization. The drug’s differentiation from existing therapies and alignment with regulatory incentives position it to capitalize on a growing demand for effective Parkinson’s disease treatments. Stakeholders must navigate competitive pressures, optimize market access, and adapt to evolving healthcare landscapes to maximize COMTAN’s commercial potential.

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Key Takeaways

• COMTAN targets a rapidly growing segment driven by increasing Parkinson’s disease prevalence and unmet therapeutic needs.
• Competitive differentiation and regulatory strategy are critical to accelerating market entry and adoption.
• Revenue projections suggest a substantial initial market share, with potential for sustained growth via indications expansion and geographic penetration.
• Cost management, reimbursement negotiations, and strategic partnerships will influence long-term profitability.
• The drug’s success hinges on balancing clinical efficacy, safety profiles, and market access considerations.

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FAQs

1. What distinguishes COMTAN from other COMT inhibitors in the market?
COMTAN offers improved bioavailability, a better safety profile, or extended dosing intervals, addressing limitations of current therapies like entacapone and tolcapone.

2. How does regulatory policy affect COMTAN’s market entry?
Expedited pathways, such as Breakthrough Therapy Designation and Priority Review, can significantly reduce approval timelines if COMTAN demonstrates substantial clinical benefit.

3. What are the risks affecting COMTAN’s financial projection?
Clinical trial failures, regulatory delays, adverse safety profiles, or market resistance due to cost concerns could hinder revenue realization.

4. Which markets pose the greatest revenue opportunities for COMTAN?
North America and Europe represent primary markets due to high prevalence rates and established healthcare infrastructure, with emerging markets providing additional growth potential.

5. How can stakeholders maximize value from COMTAN’s commercial launch?
Investing in clinical validation, early payer engagement, strategic licensing, and effective marketing campaigns will optimize adoption and financial returns.

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References

[1] World Health Organization. "The Global Burden of Parkinson’s Disease." 2022.
[2] Research and Markets. "Global Parkinson’s Therapeutics Market Growth & Trends." 2021.
[3] FDA. "Drug Development and Approval Timelines." 2022.