ENTACAPONE - Generic Drug Details

What are the generic 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, Norvium Bioscience, 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. Fourteen 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:	14
Raw Ingredient (Bulk) Api Vendors:	100
Clinical Trials:	42
Patent Applications:	7,434
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
The Affiliated Hospital of Qingdao University	Phase 1
Xiangya Hospital of Central South University	Early Phase 1
Bial - Portela C S.A.	Phase 4

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
Aurobindo Pharma Ltd	ENTACAPONE	entacapone	TABLET;ORAL	203437-001	Jun 19, 2015	AB	RX	No	No
Macleods Pharms Ltd	ENTACAPONE	entacapone	TABLET;ORAL	207210-001	Jun 5, 2017	AB	RX	No	No
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	AB	RX	Yes	Yes
Sun Pharm	ENTACAPONE	entacapone	TABLET;ORAL	090690-001	Jul 16, 2012	AB	RX	No	No
Wockhardt Bio Ag	ENTACAPONE	entacapone	TABLET;ORAL	078941-001	Aug 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	6,599,530
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	5,446,194
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,135,950
Orion Pharma	COMTAN	entacapone	TABLET;ORAL	020796-001	Oct 19, 1999	5,112,861

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/002440 Entacapone 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/000170 Entacapone 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/000171 Entacapone 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/002075 Entacapone 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

ENTACAPONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Entacapone

Introduction to Entacapone

Entacapone is a catechol-O-methyltransferase (COMT) inhibitor, commonly used in the treatment of Parkinson's disease, particularly in combination with levodopa and carbidopa. It extends the duration of action of levodopa in the brain, thereby reducing the symptoms of Parkinson's disease more effectively than levodopa alone[1].

Global Market Size and Growth

The global entacapone market has been exhibiting impressive growth, driven by the increasing prevalence of Parkinson's disease and the need for effective treatment options.

• As of 2021, the global entacapone market size was valued at several million USD, with the US, Europe, and China being significant contributors to this market. The market is forecasted to grow at a considerable CAGR during the period from 2020 to 2028[1].
• By 2028, the market is expected to reach a readjusted size, reflecting a steady growth trajectory despite the economic disruptions caused by the COVID-19 pandemic[1].

Regional Market Analysis

North America

• North America, particularly the US, holds a significant share of the global entacapone market. The region is expected to continue its dominance due to advanced healthcare infrastructure and high adoption rates of new treatments[4].

Europe

• Europe is another major market for entacapone, with countries like Germany, France, the UK, Italy, and Russia contributing substantially. Germany is projected to reach a notable market size by 2028, growing at a specific CAGR[1].

Asia-Pacific

• The Asia-Pacific region, including China, Japan, South Korea, and Southeast Asia, is witnessing rapid growth. China's market size is expected to increase significantly, trailing a high CAGR through the analysis period[1].

Latin America and Middle East & Africa

• These regions are also growing, albeit at a slower pace compared to the more developed markets. However, they present opportunities for future expansion due to increasing healthcare spending and awareness[4].

Market Segmentation

By Type

• The entacapone market is segmented based on purity levels, primarily into Purity: 98% and Purity: Above 98%. The Purity: 98% segment accounted for a significant share of the global market in 2021 and is projected to continue growing at a revised CAGR in the post-COVID-19 period[1].

By Application

• The market is also segmented by application, with Tablet Product being a major segment. Other forms like Capsule Product and others are also present but constitute a smaller share[4].

Key Players and Competitive Landscape

The global entacapone market is competitive, with several key players dominating the landscape:

• Fermion, ACIC Pharmaceuticals, Apollo Pharmaceuticals, Jubilant Pharma, RXN Chemicals, Sudarshan Solvent Industries, Precise Chemipharma, Suven Life Sciences, and HEC Pharm are among the top manufacturers. In 2021, the top five players held a significant share of the market revenue[1].

Cost-Effectiveness and Economic Impact

Entacapone has been shown to be a cost-effective treatment for Parkinson's disease:

• A study in the Netherlands demonstrated that entacapone as a complementary therapy slightly decreased total average discounted costs while increasing effectiveness in terms of quality-adjusted life years (QALYs) and time without severe motor fluctuations[2].
• Another study in Mexico highlighted the cost-utility analysis of levodopa-carbidopa versus levodopa-carbidopa-entacapone, showing that the addition of entacapone provided better outcomes at comparable costs[5].

Market Drivers and Opportunities

Increasing Prevalence of Parkinson’s Disease

• The growing number of patients with Parkinson’s disease is a significant driver for the entacapone market. As the global population ages, the demand for effective treatments is expected to rise[3].

Advancements in Treatment Options

• Research into new combinations and formulations of COMT inhibitors, including entacapone, is driving market growth. The potential use of COMT inhibitors in other medical disorders also presents new opportunities[3].

Geographical Expansion

• Emerging markets in Asia-Pacific, Latin America, and the Middle East & Africa offer substantial growth opportunities due to improving healthcare infrastructure and increasing awareness of Parkinson’s disease treatments[4].

Challenges and Restraints

Reimbursement Challenges

• Variations in insurance coverage and reimbursement policies can limit patient access to entacapone, particularly in regions with less developed healthcare systems[3].

Disease Complexity and Drug Interactions

• The complexity of Parkinson’s disease and potential drug-drug interactions can pose challenges to the widespread adoption of entacapone[3].

Financial Trajectory

Revenue Forecast

• The global entacapone market is anticipated to grow significantly, with revenue expected to increase from its current value to a projected value by 2028. The CAGR during this period is expected to be substantial, reflecting the market's growth potential[1].

Regional Revenue Share

• North America, Europe, and Asia-Pacific are expected to contribute significantly to the revenue growth, with each region showing a distinct growth trajectory based on local market dynamics[4].

Key Takeaways

• The global entacapone market is driven by the increasing prevalence of Parkinson’s disease and the need for effective treatment options.
• The market is segmented by type and application, with Purity: 98% and Tablet Product being major segments.
• Key players dominate the market, and regional growth varies with North America and Europe being significant contributors.
• Cost-effectiveness studies highlight the benefits of entacapone in treating Parkinson’s disease.
• Emerging markets and new treatment options present opportunities for future growth.

Frequently Asked Questions (FAQs)

1. What is the current size of the global entacapone market?

The global entacapone market size was valued at several million USD in 2021, with projections for significant growth by 2028[1].

2. Which regions are the major contributors to the entacapone market?

North America, Europe, and Asia-Pacific are the major regions contributing to the entacapone market, with the US, Germany, and China being key countries[1][4].

3. What are the main types of entacapone products?

The main types of entacapone products are segmented by purity levels, primarily Purity: 98% and Purity: Above 98%[1].

4. Is entacapone a cost-effective treatment for Parkinson’s disease?

Yes, studies have shown that entacapone is a cost-effective treatment, increasing effectiveness while maintaining or reducing overall treatment costs[2][5].

5. What are the challenges facing the entacapone market?

Reimbursement challenges, disease complexity, and potential drug-drug interactions are some of the challenges facing the entacapone market[3].

Cited Sources:

1. Globenewswire: Entacapone Market 2022 to Showing Impressive Growth by No of pages 85 Industry Trends Share Size Top Key Players Analysis and Forecast Research by proficient market insights.
2. PubMed: Cost-effectiveness analysis of entacapone in Parkinson's disease.
3. Credenceresearch: COMT Inhibitors Market By Size, Share, Revenue and Trends 2030.
4. Cognitivemarketresearch: Entacapone Market Report 2024 (Global Edition).
5. ISPOR: PND9 COST UTILITY ANALYSIS OF LEVODOPA-CARBIDOPA VS LEVODOPA-CARBIDOPA-ENTACAPONE IN PARKINSON DISEASE IN MEXICO.