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Last Updated: December 22, 2024

CARBIDOPA, LEVODOPA AND ENTACAPONE Drug Patent Profile


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When do Carbidopa, Levodopa And Entacapone patents expire, and what generic alternatives are available?

Carbidopa, Levodopa And Entacapone is a drug marketed by Norvium Bioscience, Rising, Sun Pharm, and Wockhardt Ltd. and is included in five NDAs.

The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

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Summary for CARBIDOPA, LEVODOPA AND ENTACAPONE
US Patents:0
Applicants:4
NDAs:5
Finished Product Suppliers / Packagers: 1
Clinical Trials: 23
What excipients (inactive ingredients) are in CARBIDOPA, LEVODOPA AND ENTACAPONE?CARBIDOPA, LEVODOPA AND ENTACAPONE excipients list
DailyMed Link:CARBIDOPA, LEVODOPA AND ENTACAPONE at DailyMed
Drug patent expirations by year for CARBIDOPA, LEVODOPA AND ENTACAPONE
Recent Clinical Trials for CARBIDOPA, LEVODOPA AND ENTACAPONE

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

SponsorPhase
The Affiliated Hospital of Qingdao UniversityPhase 1
TFS Trial Form SupportPhase 1
LobSor Pharmaceuticals ABPhase 1

See all CARBIDOPA, LEVODOPA AND ENTACAPONE clinical trials

Pharmacology for CARBIDOPA, LEVODOPA AND ENTACAPONE

US Patents and Regulatory Information for CARBIDOPA, LEVODOPA AND ENTACAPONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 203424-001 Aug 13, 2020 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-003 Nov 20, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 213212-001 Jan 25, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 203424-004 Aug 13, 2020 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rising CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 213212-006 Jan 25, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wockhardt Ltd CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 090833-005 Nov 20, 2012 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for CARBIDOPA, LEVODOPA AND ENTACAPONE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Orion Corporation Levodopa/Carbidopa/Entacapone Orion levodopa, carbidopa, entacapone EMEA/H/C/002441
Levodopa/Carbidopa/Entacapone Orion is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Authorised no no no 2011-08-23
Orion Corporation Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) levodopa, carbidopa, entacapone EMEA/H/C/002785
Corbilta is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment.
Authorised no no no 2013-11-11
Orion Corporation Stalevo levodopa, carbidopa, entacapone EMEA/H/C/000511
Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa / dopa-decarboxylase (DDC)-inhibitor treatment.
Authorised no no no 2003-10-17
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

CARBIDOPA, LEVODOPA AND ENTACAPONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Carbidopa, Levodopa, and Entacapone

Introduction

Carbidopa, levodopa, and entacapone are crucial components in the treatment of Parkinson’s disease, a progressive neurological disorder. The combination of these drugs, often referred to as Levodopa/Carbidopa/Entacapone (LCE), has significantly improved the management of Parkinson’s symptoms. Here, we delve into the market dynamics and financial trajectory of this therapeutic combination.

Market Overview

The global market for Entacapone, a key component of LCE, has shown impressive growth despite the challenges posed by the COVID-19 pandemic. The market size was estimated to be worth a significant amount in 2022 and is forecasted to grow at a considerable Compound Annual Growth Rate (CAGR) until 2028[1].

Regional Market Analysis

The market for LCE is distributed across various regions, with North America, Europe, and Asia-Pacific being the major contributors. In 2021, the US and Europe held substantial market shares, while China was also a significant player. The Chinese market is expected to grow rapidly, with a predicted increase in its proportion by 2028[1].

North America

The North American market, particularly the US, is a major hub for the consumption of LCE. The region's advanced healthcare infrastructure and high demand for effective Parkinson’s disease treatments drive the market growth.

Europe

Europe, especially Germany, is another key region. The European market is expected to continue its growth trajectory, with Germany projected to reach a significant market value by 2028[1].

Asia-Pacific

Asia-Pacific, including countries like Japan, South Korea, and Southeast Asia, is also witnessing notable growth. These regions are expected to maintain their CAGR over the next six years, contributing significantly to the global market[1].

Key Manufacturers

The global market for Entacapone is dominated by several key manufacturers, including Fermion, ACIC Pharmaceuticals, Apollo Pharmaceuticals, Jubilant Pharma, and others. In 2021, the top five players held a substantial share of the market revenue[1].

Cost-Effectiveness and Economic Impact

The cost-effectiveness of LCE has been a subject of extensive study. A Markov model analysis showed that LCE treatment results in better clinical outcomes with lower total direct costs to society compared to traditional levodopa/carbidopa treatments. From a societal perspective, LCE was found to be dominant, producing an average gain of 1.04 quality-adjusted life-years (QALYs) per patient and reducing the total 10-year direct cost of care by approximately £10,198 per patient[2].

However, from the perspective of the UK National Health Service (NHS), while LCE increased direct costs, the incremental cost-effectiveness ratio (ICER) remained below £3,800 per QALY gained, indicating its cost-effectiveness[2].

Clinical Benefits and Mechanism of Action

LCE works by enhancing the efficacy of levodopa. Levodopa is converted into dopamine in the brain, which helps alleviate Parkinson’s symptoms. Carbidopa blocks the enzyme dopa decarboxylase, preventing levodopa from being broken down outside the brain, while entacapone blocks catechol-O-methyl transferase (COMT), further prolonging the action of levodopa. This combination reduces the frequency of dosing and improves patient compliance[3].

Side Effects and Safety Profile

Common side effects of LCE include dyskinesia, muscle pain, diarrhea, nausea, and harmless urine discoloration. Serious but less common side effects include gastrointestinal hemorrhage and angioedema[3].

Comparison with Other Treatments

When compared to other COMT inhibitors like opicapone, entacapone has shown varying cost-effectiveness profiles. A study from a US payer perspective found that opicapone, although more effective in reducing OFF-time hours, was associated with higher total lifetime costs and a higher incremental cost-effectiveness ratio compared to entacapone[4].

Market Growth Drivers

Several factors drive the growth of the LCE market:

Increasing Prevalence of Parkinson’s Disease

The rising incidence of Parkinson’s disease globally is a significant driver. As the population ages, the demand for effective treatments increases.

Advancements in Treatment Options

The development of combination therapies like LCE, which offer better symptom management and patient compliance, has boosted market growth.

Regulatory Approvals

Entacapone has been authorized in the European Union since 1998, and the combination of LCE has undergone extensive clinical trials and regulatory approvals, enhancing its market acceptance[3].

Market Challenges

Despite the growth, the market faces several challenges:

Cost and Accessibility

The higher costs associated with LCE compared to traditional treatments can be a barrier, especially in regions with limited healthcare resources.

Side Effects and Safety Concerns

The potential for serious side effects, although rare, can impact patient adherence and overall market growth.

Competition from Other Treatments

The presence of other COMT inhibitors and emerging treatments can pose competition to LCE, affecting its market share.

Financial Trajectory

The financial trajectory of the LCE market is positive, with a projected significant growth rate over the next few years. The market size is expected to increase substantially by 2028, driven by the increasing demand for effective Parkinson’s disease treatments and the expanding patient population[1].

Key Takeaways

  • The global market for Entacapone and LCE is expected to grow significantly due to the increasing prevalence of Parkinson’s disease.
  • The combination of levodopa, carbidopa, and entacapone offers better clinical outcomes and cost-effectiveness compared to traditional treatments.
  • Regional markets, particularly in North America, Europe, and Asia-Pacific, are driving the growth.
  • Key manufacturers play a crucial role in the market, and regulatory approvals have been instrumental in market acceptance.
  • Despite challenges, the financial trajectory of the LCE market remains positive.

FAQs

Q: What is the primary use of Levodopa/Carbidopa/Entacapone (LCE) in medical treatment?

A: LCE is primarily used to treat adults with Parkinson’s disease, especially those experiencing end-of-dose motor fluctuations.

Q: How does Entacapone enhance the efficacy of Levodopa?

A: Entacapone blocks the enzyme catechol-O-methyl transferase (COMT), which prolongs the action of levodopa in the brain, thereby improving the symptoms of Parkinson’s disease.

Q: What are the common side effects of LCE?

A: Common side effects include dyskinesia, muscle pain, diarrhea, nausea, and harmless urine discoloration.

Q: How does the cost-effectiveness of LCE compare to other treatments?

A: LCE is generally cost-effective, especially from a societal perspective, offering better clinical outcomes with lower total direct costs. However, it may have higher direct costs from a healthcare provider's perspective.

Q: What are the key regions driving the growth of the LCE market?

A: The key regions include North America, Europe, and Asia-Pacific, with significant contributions from the US, Europe, and China.

Sources

  1. Entacapone Market 2022 to Showing Impressive Growth by - Globenewswire
  2. Cost-effectiveness of levodopa/carbidopa/entacapone (Stalevo ... - PubMed
  3. Levodopa/Carbidopa/Entacapone Orion - European Medicines Agency
  4. Cost-effectiveness of opicapone and entacapone in reducing OFF ... - PubMed
  5. Clinical Pharmacology of Entacapone (Comtan) From the FDA ... - Oxford Academic

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