Entacapone - Generic Drug Details

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

Entacapone is the generic ingredient in two branded drugs marketed by Orion Pharma, Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Pharmobedient, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for entacapone. Thirteen suppliers are listed for this compound.

Summary for entacapone

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	44
Patent Applications:	8,314
Drug Prices:	Drug price trends for entacapone
What excipients (inactive ingredients) are in entacapone?	entacapone excipients list
DailyMed Link:	entacapone at DailyMed

See drug prices for entacapone

Recent Clinical Trials for entacapone

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

Sponsor	Phase
University Hospital Tuebingen	PHASE3
The Affiliated Hospital of Qingdao University	Phase 1
Second Affiliated Hospital of Soochow University	PHASE4

See all entacapone clinical trials

Pharmacology for entacapone

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

Anatomical Therapeutic Chemical (ATC) Classes for entacapone

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

Paragraph IV (Patent) Challenges for ENTACAPONE

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

US Patents and Regulatory Information for entacapone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt Bio Ag	ENTACAPONE	entacapone	TABLET;ORAL	078941-001	Aug 16, 2012	AB	RX	No	No
Pharmobedient	ENTACAPONE	entacapone	TABLET;ORAL	202394-001	May 13, 2013		DISCN	No	No
Sun Pharm	ENTACAPONE	entacapone	TABLET;ORAL	090690-001	Jul 16, 2012	AB	RX	No	No

Expired US Patents for entacapone

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

EU/EMA Drug Approvals for entacapone

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Entacapone

Last updated: July 27, 2025

Introduction

Entacapone, marketed under brand names such as Comtan, is a selective and reversible catechol-O-methyltransferase (COMT) inhibitor primarily used in Parkinson’s disease management. Since its approval by the FDA in 1999, entacapone’s role has evolved, impacting its market dynamics and financial prospects. This analysis explores the key drivers, competitive landscape, regulatory environment, and future financial outlook for entacapone, providing insights critical for stakeholders across the pharmaceutical spectrum.

Market Overview and Therapeutic Context

Parkinson’s disease (PD), a progressive neurodegenerative disorder affecting approximately 6 million individuals globally, demands multifaceted treatment approaches. Conventional therapies, notably levodopa/carbidopa, face challenges such as motor fluctuations and dyskinesia over time. COMT inhibitors like entacapone augment levodopa’s efficacy by prolonging its plasma half-life, thereby improving symptom control.

Entacapone occupies a niche within PD therapeutics; it is often combined with levodopa/carbidopa, forming a foundational treatment component. The global PD drug market, projected to reach USD 9 billion by 2026 with a CAGR of around 4.8%, signals growing demand fueled by aging populations and increased awareness.

Key Market Drivers

• Aging Demographics: The prevalence of PD escalates with age, targeting populations above 60. As global life expectancy rises, so does the need for PD management.
• Advancements in Symptom Management: Enhanced formulations and combination therapies with entacapone improve patient outcomes, bolstering its clinical utility.
• Expanding Access: Countries in Asia, Latin America, and Eastern Europe are expanding healthcare infrastructure, facilitating broader distribution and access.
• Patent Expiry and Generics: While the original patent for Comtan expired in 2016, generic versions have entered predominant markets, affecting pricing strategies and revenue streams.

Market Dynamics

Competitive Landscape

Entacapone competes primarily with tolcapone, another COMT inhibitor, and newer dopamine agonists or MAO-B inhibitors. Tolcapone, despite higher efficacy, is limited due to severe hepatotoxicity risks, positioning entacapone as the safer mainstream option.

Generic manufacturing has increased affordability, shrinking revenue per unit but expanding volume sales. Major pharmaceutical companies like Novartis and Teva have significant stakes through licensing agreements and generics.

Regulatory Environment & Patent Landscape

Regulatory approvals in multiple jurisdictions have maintained entacapone's market presence. However, the patent landscape influences pricing strategies, with patent cliffs precipitating generic competition. Notably, the patent expiration of Comtan led to price reductions of up to 50% in key markets, impacting revenue.

Regulatory authorities have emphasized post-marketing surveillance for adverse effects, mainly hepatotoxicity concerns linked with tolcapone, which benefits entacapone's market stability.

Pricing and Reimbursement Trends

In established markets like the U.S. and Europe, reimbursement policies favor combination PD therapies, including entacapone. However, price pressures due to generics and healthcare cost containment are notable. Price transparency and negotiated drug prices influence overall revenue.

Emerging Markets and Demographic Shifts

Emerging markets represent significant growth opportunities driven by increased healthcare infrastructure and rising PD diagnosis rates. Lower-cost generics are particularly appealing in these regions, further expanding access.

Research & Development Impact

Ongoing research exploring fixed-dose combinations, novel formulations (e.g., extended-release), and combination therapies could influence future demand and market share. Investment in pharmacogenomics and personalized medicine could tailor entacapone's use, affecting adoption rates.

Financial Trajectory Analysis

Historical Revenue Trends

Post-approval, entacapone experienced rapid initial uptake, especially among specialist neurologists. The patent cliff in 2016 resulted in revenue declines in developed markets, as generic versions flooded the market, with estimates indicating a 30-50% revenue reduction in some regions.

Projected Market Growth

Despite patent expiries, the market is expected to sustain growth due to increasing PD prevalence and new formulation innovations. The CAGR is predicted to stabilize around 2.5%-3% over the next five years, driven by volume growth rather than high-margin sales.

Revenue Forecasts

• Developed Markets: Flat or declining revenues post-patent expiry; however, sustained through generics and expanded indications.
• Emerging Markets: Rapid growth predicted, with compounded annual sales increase of up to 10%, driven by price-sensitive and expanding healthcare infrastructure.
• Pipeline Developments: New formulations and combination therapies could revive sales figures, offering premium pricing opportunities.

Profitability Considerations

Profit margins are under pressure due to generic price erosion. Companies adopting aggressive pricing, cost-efficient manufacturing, and strategic licensing are better positioned to sustain profitability.

Risks and Opportunities

• Risks: Patent expirations, clinical adoption of rival therapies, and regulatory setbacks may dampen revenues.
• Opportunities: Innovation in delivery methods, combination regimens, and geographic expansions can prop up financial trajectories.

Future Outlook

The outlook for entacapone hinges on innovation and market expansion opportunities. The growing focus on personalized medicine and combination therapies offers avenues for niche premium products. Strategic partnerships and licensing agreements in emerging markets will be critical to sustain growth. Additionally, ongoing clinical trials exploring neuroprotective properties could broaden its therapeutic scope, potentially transforming its market trajectory.

Key Takeaways

• Market Longevity Post-Patent Expiry: Despite patent expiration, entacapone retains relevance due to its established efficacy and cost-effectiveness, especially in emerging markets.
• Pricing Strategies Are Critical: Companies will need to balance affordability with profitability, particularly as generics dominate.
• Innovation Drives Growth: New formulations, combination therapies, and personalized approaches will be essential to rejuvenate sales.
• Emerging Markets Are Key Growth Zones: Expanding healthcare access and demographic shifts make these regions vital for long-term revenue streams.
• Regulatory and Safety Profiling Affects Market Dynamics: Continued monitoring for hepatotoxicity and other adverse effects influences prescribing patterns and market acceptance.

FAQs

1. How does entacapone compete with other Parkinson’s disease therapies?
Entacapone complements levodopa/carbidopa therapy, improving symptom control by prolonging drug activity. Unlike dopamine agonists or MAO-B inhibitors, it specifically inhibits COMT, making it a targeted adjunct. Its safety profile and cost-effectiveness favor its continued use, especially where generic options are available.

2. What impact did patent expiration have on entacapone's market revenues?
The patent expiry in 2016 led to a surge in generic supply, driving prices down and reducing revenue for originator companies by up to 50% in certain regions. However, volume sales and expanding indications have mitigated some revenue losses.

3. Are there any upcoming formulations or combination therapies involving entacapone?
Research focuses on fixed-dose combinations, extended-release formulations, and potential neuroprotective adjuncts. While none are yet standard, ongoing clinical studies indicate a promising pipeline, potentially expanding its market.

4. What demographic trends are influencing the future of entacapone?
An aging global population increases PD prevalence, expanding the potential user base. Developing markets with improving healthcare systems further accelerate access and utilization.

5. How does the safety profile of entacapone compare with tolcapone?
Entacapone is generally safer, with fewer hepatotoxicity concerns, which led to its preference over tolcapone. Ongoing monitoring ensures safety standards support its continued use.

References

[1] Global Parkinson’s Disease Market. (2022). Market Research Future.
[2] U.S. Food & Drug Administration (FDA). (1999). Approval of Comtan.
[3] European Medicines Agency (EMA). (2016). Patent expiration details.
[4] World Health Organization. (2020). Global Parkinson’s Disease Report.
[5] Pharmaceutical Industry Reports. (2021). Market analysis for COMT inhibitors.