CARBIDOPA; ENTACAPONE; LEVODOPA - Generic Drug Details

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

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

Four suppliers are listed for this compound.

Summary for CARBIDOPA; ENTACAPONE; LEVODOPA

US Patents:	0
Tradenames:	7
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	4
Clinical Trials:	24
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
Second Affiliated Hospital of Soochow University	PHASE4
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
Pharmobedient	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	203424-006	Aug 13, 2020		DISCN	No	No
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-005	Jan 25, 2022	AB	RX	No	No
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-006	Jan 25, 2022	AB	RX	No	No
Rising	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	213212-001	Jan 25, 2022	AB	RX	No	No
Sun Pharm	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	079085-002	May 10, 2012		DISCN	No	No
Macleods Pharms Ltd	CARBIDOPA, LEVODOPA AND ENTACAPONE	carbidopa; entacapone; levodopa	TABLET;ORAL	214495-003	Apr 15, 2025	AB	RX	No	No

Expired US Patents for CARBIDOPA; ENTACAPONE; LEVODOPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003
Orion Pharma	STALEVO 75	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-005	Aug 29, 2008

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/002441Levodopa/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/002785Corbilta 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/000511Stalevo 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

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

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for Parkinson’s disease (PD) therapies is characterized by evolving market dynamics driven by demographic shifts, advanced therapeutics, regulatory reforms, and commercialization strategies. Central to this segment are the drugs Carbidopa, Entacapone, and Levodopa — cornerstone agents in PD management. This analysis examines the current market environment, growth drivers, competitive trends, and financial prospects associated with these drugs, providing stakeholders with strategic insights.

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Market Overview

Parkinson’s Disease Burden

Parkinson’s disease, a progressive neurodegenerative disorder affecting over 10 million globally, primarily impacts populations aged 60 and above. As longevity increases, the prevalence of PD accelerates, amplifying demand for effective management options. The global PD therapeutics market was valued at approximately USD 4.3 billion in 2021 and is projected to reach USD 6.7 billion by 2028, growing at a CAGR of around 6.3% [1].

Therapeutic Role of Carbidopa, Entacapone, and Levodopa

Levodopa remains the most efficacious agent in PD symptom control, often combined with Carbidopa to inhibit peripheral conversion, thereby increasing central nervous system availability. Entacapone, a COMT inhibitor, is commonly added adjunctively to prolong levodopa’s effect. These drugs are considered foundational, with generic formulations dominating cost-sensitive markets and branded options maintaining premium due to innovation and patent protections.

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Market Dynamics

1. Demographic and Epidemiological Drivers

Globally aging populations are primary market catalysts. For instance, the World Health Organization projects that by 2050, individuals aged 60+ will constitute 16% of the population, intensifying PD prevalence [2]. Developed markets, notably the U.S. and Europe, possess extensive patient bases requiring sustained pharmacotherapy, fostering a resilient demand pipeline.

2. Patent Expiry and Generic Transition

Generic proliferation exerts downward pricing pressure on Levodopa and Carbidopa formulations, especially in mature markets. While branded variants have historically commanded premium margins, patent expirations have initiated widespread substitution with lower-cost generics. However, some differentiated formulations, such as controlled-release or combination medications with novel delivery systems, retain patent portfolios, sustaining higher margins temporarily.

3. R&D and Innovation

Innovation in formulation science, including controlled-release delivery systems, transdermal patches, and combination therapies, influence market share dynamics. While Carbidopa, Entacapone, and Levodopa are established, incremental innovations extend product life cycles. Companies investing in these advancements expect to counteract generic competition and enhance therapeutic efficacy, thus maintaining or growing revenue streams.

4. Regulatory Environment

Stringent regulatory frameworks in key markets affect market entry and product approval timelines. The FDA and EMA continue to promote biosimilar and generic drug approvals, which accelerates price competition. Conversely, novel conjugates and fixed-dose combinations may benefit from exclusivity periods and accelerated approval pathways.

5. Market Penetration and Accessibility

High affordability and widespread availability characterize core markets, but access remains limited in low-income regions due to cost and healthcare infrastructure deficiencies. This disparity limits growth potential in certain geographies but presents opportunities for market expansion through tailored pricing strategies and partnerships.

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Financial Trajectory

1. Revenue Trends

The combined revenues from Levodopa, Carbidopa, and Entacapone have been relatively stable but exhibit regional divergence. In mature markets, revenues plateau due to patent expirations; however, emerging markets demonstrate high growth owing to increasing PD diagnoses and rising healthcare expenditure. For example, sales in Asia-Pacific are projected to grow at over 8% CAGR through 2028, surpassing traditional markets [3].

2. Pricing Dynamics

Pricing strategies are increasingly influenced by generics and biosimilars. Average wholesale prices (AWP) for branded Levodopa formulations have declined by approximately 20% over the past five years in the U.S., while generic versions are priced 40-60% lower. Meanwhile, premium formulations with innovative delivery systems maintain higher price points, supporting profit margins.

3. Investment and R&D Spending

Pharmaceutical companies are allocating substantial R&D budgets toward developing next-generation PD therapies, including gene therapies and neuroprotective agents. Although these innovations could supplant traditional drugs in the long term, investments bolster the incumbent market’s value by expanding indications and improving safety profiles.

4. Market Share and Competitive Positioning

Leading firms such as AbbVie, Teva, and Mylan hold significant shares in generics for Levodopa and Carbidopa. Meanwhile, blockbuster brands like Sinemet® (Levodopa/Carbidopa) maintain dominance through established clinical efficacy and patient adherence. Entacapone’s market share is bolstered by combination drugs like Stalevo®, which integrate multiple mechanisms, enhancing therapeutic convenience.

5. Impact of Regulatory and Patent Strategies

Patent extensions and new formulations prolong exclusivity periods, enabling premium pricing. Conversely, the pursuit of biosimilar and generic alternatives intensifies price competition, impacting revenue trajectories. Strategic patent filings and patent litigations shape the competitive landscape.

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Market Drivers and Challenges

Drivers

• Increasing PD prevalence due to aging demographics
• Continuous innovation in drug formulations and delivery systems
• Expansion into emerging markets with rising healthcare access
• Regulatory incentives for novel combination therapies

Challenges

• Price erosion driven by generics and biosimilars
• Patent expirations leading to revenue declines in mature markets
• Regional disparities in healthcare infrastructure and affordability
• Potential adverse effects limiting drug combination formulations' market appeal

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Opportunities for Growth

• Biogenerics and Biosimilars: Developing biosimilar versions of branded Levodopa combinations can capture market share amid patent cliffs.
• Value-added Formulations: Introducing sustained-release, transdermal, or implantable devices improves patient adherence and distinguishes products.
• Regional Expansion: Penetrating underserved markets offers significant growth potential, especially through local manufacturing partnerships.
• Combination Therapies: Creating fixed-dose combinations can enhance convenience, foster brand loyalty, and command premium pricing.

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Key Takeaways

• The market for Carbidopa, Entacapone, and Levodopa remains robust, propelled largely by demographic trends and sustained clinical efficacy.
• Generic entry has pressured revenues, but innovation in formulations and delivery mechanisms sustains profitability for key players.
• Emerging markets and regions with expanding healthcare infrastructure offer substantial long-term growth opportunities.
• Market participants must navigate patent landscapes strategically, balancing innovation investments with cost competitiveness.
• Ongoing R&D, particularly in pharmacokinetic enhancements and combination therapies, will be vital to maintaining market positioning and financial stability.

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FAQs

Q1: How will patent expirations affect the revenue of Levodopa products?
A1: Patent expirations lead to generic competition, which typically results in a significant reduction in brand-name drug revenues. Companies often combat this through new formulations, delivery systems, or combination therapies that can extend exclusivity periods.

Q2: What role do biosimilars and biogenerics play in this market?
A2: While traditional Levodopa and Carbidopa are small molecules with limited biosimilar options, innovations like biosimilar combination drugs and advanced delivery systems are emerging, potentially reducing costs and increasing accessibility.

Q3: Are there notable innovations beyond traditional formulations for these drugs?
A3: Yes. Innovations include controlled-release matrices, transdermal patches, implantable delivery devices, and fixed-dose combination pills, all aimed at improving patient adherence and therapeutic outcomes.

Q4: Which regions present the highest growth potential for these drugs?
A4: Asia-Pacific, Latin America, and Africa offer significant growth due to increasing PD prevalence, improving healthcare infrastructure, and population size, despite current affordability challenges.

Q5: What strategic actions should pharmaceutical companies consider?
A5: Firms should invest in formulation innovation, pursue strategic patent protections, explore regional expansion, and develop tailored pricing strategies to navigate market challenges and capitalize on growth opportunities.

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References

1. Grand View Research. Parkinson’s Disease Therapeutics Market Size, Share & Trends Analysis Report. 2022.
2. World Health Organization. Ageing and Health. 2021.
3. IQVIA. The Global Use of Medicines in 2022.

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This comprehensive review aims to inform decision-makers and stakeholders about the evolving market landscape for Carbidopa, Entacapone, and Levodopa, anchoring strategic planning in current industry dynamics and future outlooks.