Carbidopa; levodopa - Generic Drug Details

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

Carbidopa; levodopa is the generic ingredient in nine branded drugs marketed by Impax, Abbvie, Accord Hlthcare, Alembic, Apotex, Impax Labs, Kv Pharm, Mylan, Rubicon Research, Sciegen Pharms Inc, Sun Pharm Inds, Organon Llc, Ranbaxy, Rising, Sun Pharm, Ucb Inc, Actavis Elizabeth, Ani Pharms, Apotex Inc, Ascent Pharms Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Pharmobedient, SCS, Watson Labs, Zydus Pharms, Avion Pharms, and Organon, and is included in thirty-seven NDAs. There are thirty-five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carbidopa; levodopa has sixty-five patent family members in fifteen countries.

Thirty-six suppliers are listed for this compound.

Summary for carbidopa; levodopa

International Patents:	65
US Patents:	35
Tradenames:	9
Applicants:	28
NDAs:	37
Finished Product Suppliers / Packagers:	36
Clinical Trials:	192
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbidopa; levodopa
DailyMed Link:	carbidopa; levodopa at DailyMed

Recent Clinical Trials for carbidopa; levodopa

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

Sponsor	Phase
The Cleveland Clinic	PHASE4
Julien Bally	PHASE1
Impax Laboratories, LLC	PHASE4

See all carbidopa; levodopa clinical trials

Pharmacology for carbidopa; levodopa

Drug Class

Aromatic Amino Acid

Anatomical Therapeutic Chemical (ATC) Classes for carbidopa; levodopa

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

Paragraph IV (Patent) Challenges for CARBIDOPA; LEVODOPA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CREXONT	Extended-release Capsules	carbidopa; levodopa	35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg	217186	1	2024-09-23
RYTARY	Extended-release Capsules	carbidopa; levodopa	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg	203312	1	2015-06-24
RYTARY	Extended-release Capsules	carbidopa; levodopa	61.25 mg/245 mg	203312	1	2015-06-10

US Patents and Regulatory Information for carbidopa; levodopa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes			Y
Sun Pharm Inds	CARBIDOPA AND LEVODOPA	carbidopa; levodopa	TABLET;ORAL	078536-003	Oct 28, 2008	AB	RX	No	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes			Y

Expired US Patents for carbidopa; levodopa

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-002	Approved Prior to Jan 1, 1982
Organon	SINEMET	carbidopa; levodopa	TABLET;ORAL	017555-001	Approved Prior to Jan 1, 1982
Organon Llc	SINEMET CR	carbidopa; levodopa	TABLET, EXTENDED RELEASE;ORAL	019856-002	Dec 24, 1992

EU/EMA Drug Approvals for carbidopa; levodopa

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amneal Pharma Europe Ltd	Numient	levodopa, carbidopa	EMEA/H/C/002611Symptomatic treatment of adult patients with Parkinson’s disease	Withdrawn	no	no	no	2015-11-19

International Patents for carbidopa; levodopa

Country	Patent Number	Title	Estimated Expiration
China	101910113	Controlled release formulations of levodopa and uses thereof
Israel	206756	תערובות שחרור מבוקרות של levodopa ושימושיהן (Controlled release formulations of levodopa and uses thereof)
European Patent Office	3054929	FORMULATIONS MUCOADHÉSIVES À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET/OU D'ESTERS DE LÉVODOPA ET LEURS UTILISATIONS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)
South Korea	20210072838	레보도파 및/또는 레보도파의 에스테르의 점막-점착성, 제어 방출형 제제 그리고 이의 용도 (/ - MUCO-ADHESIVE CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)

Supplementary Protection Certificates for carbidopa; levodopa

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for Carbidopa-Levodopa

Last updated: July 29, 2025

Introduction

Carbidopa-levodopa remains the gold standard in managing Parkinson’s disease (PD), a neurodegenerative disorder affecting approximately 10 million people globally [1]. This combination therapy provides symptomatic relief by replenishing dopamine levels in the brain, with a well-established efficacy profile. As the PD epidemic accelerates amid aging populations worldwide, understanding the market dynamics and financial trajectory of this drug is vital for stakeholders—including pharmaceutical companies, investors, healthcare providers, and policymakers.

Market Overview

Global Market Size and Growth Drivers

The global Parkinson’s disease treatment market was valued at approximately USD 4.4 billion in 2021 and is projected to surpass USD 8 billion by 2028, growing at a compound annual growth rate (CAGR) of around 9% [2]. Carbidopa-levodopa comprises roughly 60-70% of this market, reflecting its status as the primary therapeutic agent. Factors propelling this growth include the rising prevalence of PD, advances in drug formulations, and increased awareness and diagnosis.

Epidemiological Trends

The incidence of PD globally is increasing, driven by aging demographics and improved diagnostic methods. The World Parkinson’s Program estimates a prevalence of 1 million cases in North America alone, with similar trends in Europe and Asia [1]. This expanding patient base underpins sustained demand for carbidopa-levodopa, forming a substantial revenue base for manufacturers.

Market Dynamics

Patent Landscape and Generic Competition

Most brand-name formulations of carbidopa-levodopa were initially protected by patents, securing market exclusivity. However, patent expirations—such as the original formulations of Sinemet—have led to a surge in generic equivalents, intensifying price competition. The entry of generics has generally precipitated a decrease in prices, impacting revenue trajectories for branded products [3].

Product Innovation and Formulation Developments

Innovation within the carbidopa-levodopa market is primarily centered on enhancing delivery mechanisms:

• Extended-release formulations: Improve on-off phenomenon management and provide more stable plasma dopamine levels.
• Novel delivery systems: Including inhalable, subcutaneous, or implantable devices aimed at optimizing absorption and reducing peripheral side effects.

These advancements aim to capture premium pricing and improve patient adherence, indirectly boosting market size.

Regulatory Environment

Regulatory agencies, notably the FDA and EMA, have standardized approval pathways for generics, facilitating rapid market entry and increasing price competition. Conversely, proprietary formulations with improved bioavailability or delivery systems may enjoy extended exclusivity periods, allowing manufacturers to command higher prices temporarily.

Reimbursement Landscape

In major markets, reimbursement policies influence drug accessibility and pricing strategies. Favorable coverage for branded formulations with proven clinical benefits sustains higher margins, while greater reimbursement pressures for generics can compress profit margins.

Supply Chain and Manufacturing Factors

Manufacturing complexities, especially for formulations with specialized delivery systems, influence production costs. Supply chain disruptions—whether due to geopolitical, pandemic, or raw material shortages—can impact pricing, availability, and market stability.

Financial Trajectory

Revenue Streams and Profitability

Established brands like Sinemet (by UCB/AbbVie), funded primarily through patents, historically generated billions annually. As patents expire, revenue shifts toward generics, with significantly lower margins but higher volume sales.

Emerging formulations with new delivery mechanisms are positioned as premium products, with potential for high margins if differentiated effectively. For example, extended-release formulations command higher prices and loyalty, cushioning revenue declines from generic erosion.

Market Entry and Competition

The influx of generics post-patent expiry typically lowers drug prices by 30-60%, leading to immediate revenue dips for brand-name manufacturers. However, commercialization of innovative formulations can offset this effect within niche markets.

Predicted trends suggest that in the next decade:

• Gradual decline in revenue from standard immediate-release formulations owing to generic competition.
• Growth in specialty formulations targeting improved quality of life and disease management.
• Expansion into emerging markets as pricing strategies adapt to local affordability.

R&D Investment and Pipeline Outlook

Pharmaceutical companies are investing in research to develop novel delivery systems and combination therapies. While R&D costs are substantial, successful innovation could secure higher pricing, regulatory exclusivity, and market share, supporting long-term financial stability.

Future Market Opportunities

Key avenues include:

• Personalized medicine approaches targeting specific patient subgroups.
• Technological advances: such as implantable devices and gene therapies, for disease modification.
• Emerging markets expansion: with tailored price strategies to expand reach.

With the aging population projected to double by 2050, the demand for Parkinson’s therapies—including carbidopa-levodopa—will continue rising, even as competitors innovate around delivery and efficacy.

Risks and Challenges

Notable risks include:

• Competitive pressures from generics and biosimilars.
• Regulatory hurdles impeding new formulations.
• Pricing pressures driven by healthcare systems and payers.
• Potential for market saturation in developed countries.

These factors necessitate strategic diversification and innovation to secure sustained revenues.

Key Takeaways

• The global Parkinson’s market is expanding, driven by demographic trends and disease prevalence.
• Carbidopa-levodopa remains the cornerstone therapy, although patent expirations and generic competition are exerting downward price pressures.
• Innovation in drug delivery systems offers potential for premium pricing and extended market exclusivity.
• Revenue trajectories depend heavily on formulation differentiation, regulatory positioning, and regional reimbursement frameworks.
• Long-term growth prospects hinge on technological advancement, pipeline development, and expansion into emerging markets.

FAQs

1. How will patent expiries influence the revenue of carbidopa-levodopa?
Patent expiries typically lead to generic entry, causing significant reductions in prices and revenues for brand-name manufacturers. However, companies can mitigate these effects by developing superior formulations or delivery systems that warrant premium pricing and extended exclusivity.

2. What are emerging innovations in carbidopa-levodopa formulations?
Recent innovations focus on extended-release formulations, inhalable options, implantable pumps, and novel delivery mechanisms aimed at improving bioavailability, reducing fluctuations, and enhancing patient compliance.

3. How does the global prevalence of Parkinson’s disease impact market growth?
An increasing PD prevalence, primarily due to aging populations, sustains demand for symptomatic therapies like carbidopa-levodopa, underpinning a steady growth trajectory in the global market.

4. What are the key risks facing the financial stability of companies producing carbidopa-levodopa?
Key risks include aggressive generic competition, regulatory delays for new formulations, reimbursement challenges, and pricing pressures from healthcare systems.

5. What strategies can stakeholders adopt to optimize long-term financial outcomes?
Stakeholders should focus on continuous innovation, diversifying product portfolios, expanding into emerging markets, and engaging in strategic patent protections and lifecycle management.

References

[1] World Parkinson’s Program, “Global Epidemiology and Market Trends,” 2022.
[2] MarketWatch, “Pharmaceuticals: Parkinson’s Disease Drugs Market Size & Trends,” 2023.
[3] IMS Health, “Impact of Patent Expiry on Parkinson’s Medication Market,” 2021.