Carbidopa; entacapone; levodopa - Generic Drug Details

What are the generic sources for carbidopa; entacapone; levodopa and what is the scope of patent protection?

Carbidopa; entacapone; levodopa is the generic ingredient in seven branded drugs marketed by Norvium Bioscience, Rising, Sun Pharm, Wockhardt Ltd, and Orion Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for carbidopa; entacapone; levodopa

US Patents:	0
Tradenames:	7
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	3
Clinical Trials:	23
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbidopa; entacapone; levodopa
DailyMed Link:	carbidopa; entacapone; levodopa at DailyMed

Recent Clinical Trials for carbidopa; entacapone; levodopa

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

Sponsor	Phase
The Affiliated Hospital of Qingdao University	Phase 1
TFS Trial Form Support	Phase 1
LobSor Pharmaceuticals AB	Phase 1

See all carbidopa; entacapone; levodopa clinical trials

Pharmacology for carbidopa; entacapone; levodopa

Drug Class	Aromatic Amino Acid Catechol-O-Methyltransferase Inhibitor
Mechanism of Action	Catechol O-Methyltransferase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; entacapone; levodopa

N04BA	Dopa and dopa derivatives
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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

US Patents and Regulatory Information for carbidopa; entacapone; levodopa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wockhardt Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	090786-001	Nov 20, 2012		DISCN	No	No
Sun Pharm	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	079085-002	May 10, 2012	AB	RX	No	No
Norvium Bioscience	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	203424-004	Aug 13, 2020		DISCN	No	No
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No
Sun Pharm	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	079085-001	May 10, 2012	AB	RX	No	No
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for carbidopa; entacapone; levodopa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	5,112,861
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,500,867
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	6,797,732
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008	6,797,732
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	6,797,732
Orion Pharma	STALEVO 50	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-001	Jun 11, 2003	5,135,950

EU/EMA Drug Approvals for carbidopa; entacapone; levodopa

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

Carbidopa; entacapone; levodopa Market Analysis and Financial Projection Experimental

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

Introduction to the Drugs

Carbidopa, entacapone, and levodopa are crucial components in the treatment of Parkinson's disease, a progressive neurodegenerative disorder. Here’s a detailed look at the market dynamics and financial trajectory of these drugs.

Market Overview

Parkinson's Disease Prevalence

The global market for these drugs is significantly driven by the increasing prevalence of Parkinson's disease. As the population ages, the demand for effective treatments for Parkinson's disease is on the rise. Parkinson's disease is the second most common neurodegenerative disorder worldwide, and this trend is expected to continue, driving the growth of the market[4].

Combination Therapy: Levodopa/Carbidopa/Entacapone (LCE)

The combination therapy of levodopa, carbidopa, and entacapone, known as LCE or Stalevo, has been a game-changer in managing Parkinson's disease symptoms. This triple combination enhances the bioavailability of levodopa in the brain, leading to improved on-time or symptom-free periods for patients. The FDA approved LCE in June 2003 for treating motor fluctuations in adult patients with Parkinson's disease[3].

Market Dynamics

Demand Drivers

• Aging Population: The increasing life expectancy and aging population are key drivers of the market. As people live longer, the incidence of Parkinson's disease rises, leading to higher demand for these medications[4].
• Healthcare Infrastructure: Regions with robust healthcare infrastructure, such as North America, drive innovation and access to these treatments. Advanced medical research facilities and supportive healthcare policies contribute to market growth[4].
• Technological Advancements: Continuous research and development in drug delivery systems and personalized medicine are shaping the treatment landscape and driving market growth[4].

Market Segmentation

• Geographical Markets: The global market is segmented geographically, with North America dominating the levodopa market due to its advanced healthcare infrastructure and high prevalence of Parkinson's disease. Asia-Pacific is projected to offer significant business opportunities in the future[4].
• Product Forms: The market is also segmented by form, with tablets being the most popular form of levodopa in 2022[4].

Financial Trajectory

Market Size and Growth

• Levodopa Market: The global levodopa market was valued at $1.7 billion in 2022 and is projected to reach $2.9 billion by 2032, growing at a CAGR of 6.1% from 2023 to 2032[4].
• Entacapone Market: The global entacapone market, though smaller, is also showing impressive growth. Despite the impact of the COVID-19 pandemic, the market is forecast to grow at a significant CAGR during the review period, with China, the US, and Europe being key markets[1].

Cost-Effectiveness

• LCE Combination: Studies have shown that the LCE combination is cost-effective, especially in the long term. For instance, a Markov model analysis indicated that LCE treatment produced better clinical outcomes with lower costs to society compared to traditional levodopa/carbidopa therapy. The incremental cost-effectiveness ratio (ICER) for LCE was found to be within the range considered highly acceptable[2].

Revenue and Market Share

• Key Players: Major pharmaceutical companies such as Novartis AG, Merck & Co. Inc., Eli Lilly & Company, and others dominate the market. In 2021, the global top five players in the entacapone market had a significant share in terms of revenue[1].
• Regional Growth: China's proportion in the entacapone market is expected to increase significantly by 2028, with a predicted CAGR during the analysis period. Germany is also projected to be a significant market in Europe, growing at a notable CAGR[1].

Economic Impact

Savings and Costs

• Societal Savings: The use of LCE has been shown to offer savings to society by reducing other direct costs associated with Parkinson's disease, such as social care and private expenditures. Despite the higher cost of the medication itself, the overall cost-effectiveness is favorable[2].

Healthcare Expenditure

• Healthcare Spending: The rise in healthcare expenditure and the increasing focus on managing chronic diseases like Parkinson's drive the financial trajectory of these drugs. Supportive healthcare policies and reimbursement frameworks ensure widespread access to these medications, contributing to market growth[4].

Key Takeaways

• The market for carbidopa, entacapone, and levodopa is driven by the increasing prevalence of Parkinson's disease and advancements in healthcare infrastructure.
• The combination therapy of LCE is cost-effective and offers better clinical outcomes.
• The global levodopa market is projected to grow significantly, reaching $2.9 billion by 2032.
• Key players in the market include major pharmaceutical companies, and regional growth is expected in Asia-Pacific and Europe.

FAQs

What is the primary driver of the market for carbidopa, entacapone, and levodopa?

The primary driver is the increasing prevalence of Parkinson's disease, particularly among the aging population.

How does the LCE combination therapy benefit patients with Parkinson's disease?

The LCE combination enhances the bioavailability of levodopa in the brain, leading to improved on-time or symptom-free periods for patients and better management of motor fluctuations.

What is the projected growth rate of the global levodopa market?

The global levodopa market is projected to grow at a CAGR of 6.1% from 2023 to 2032.

Which regions are expected to provide significant business opportunities for the levodopa market?

Asia-Pacific and North America are expected to provide significant business opportunities, with North America currently dominating the market.

Is the LCE combination therapy cost-effective?

Yes, studies have shown that the LCE combination is cost-effective, offering better clinical outcomes with lower costs to society compared to traditional therapies.

Sources

1. Entacapone Market 2022 to Showing Impressive Growth by - Globenewswire
2. Cost-effectiveness of levodopa/carbidopa/entacapone (Stalevo ... - PubMed
3. Levodopa/Carbidopa/Entacapone Combination Therapy - NCBI - PubMed
4. Levodopa Market Size, Growth Analysis | Forecast - 2032 - Allied Market Research
5. PND9 COST UTILITY ANALYSIS OF LEVODOPA-CARBIDOPA VS ... - ISPOR