STALEVO 200 Drug Patent Profile

Which patents cover Stalevo 200, and what generic alternatives are available?

Stalevo 200 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 200 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 200

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for STALEVO 200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orion Pharma	STALEVO 200	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-004	Aug 2, 2007	AB	RX	Yes	Yes

International Patents for STALEVO 200

See the table below for patents covering STALEVO 200 around the world.

Country	Patent Number	Title	Estimated Expiration
Italy	1225762	COMPOSTI FARMACOLOGICAMENTE ATTIVI, PROCEDIMENTI PER LA LORO PREPARAZIONE E COMPOSIZIONI CHE LI CONTENGONO.
Australia	8187987
Hungary	T45473
United Kingdom	8727854
Eurasian Patent Organization	200200106
Japan	H085781
Finland	991485

Supplementary Protection Certificates for STALEVO 200

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
0426468	CA 2004 00007	Denmark
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0426468	0490007-2	Sweden		PRODUCT NAME: (E)-2-CYANO-N,N-DIETYL-3-(3,4-DIHYDROXI-5-NITROFENYL)AKRYLAMID; REGSISTRATION NO/DATE: EU/1/03/260/001 20031017
0426468	91071	Luxembourg		91071, EXPIRES: 20151101

Investment Scenario, Market Dynamics, and Financial Trajectory for STALEVO 200

Last updated: February 3, 2026

Executive Summary

STALEVO 200 (containing levodopa/carbidopa/entacapone at a potency of 200 mg levodopa per dose) is a prescription medication used in the management of Parkinson’s disease (PD). As a combination therapy, it offers extended therapeutic benefits over traditional levodopa formulations. This report analyzes its current market landscape, investment potential, key market drivers, competitive positioning, regulatory influences, and future revenue forecasts.

Market Overview and Key Metrics

Aspect	Data & Insights
Indication	Parkinson’s Disease (PD)
Market Size (2023)	$6.1 billion (global PD drug market) [1]
Estimated Market CAGR (2023–2028)	7.8% [2]
Key Components	Levodopa, Carbidopa, Entacapone
Approved By	FDA (United States), EMA (Europe), PMDA (Japan)

Current Market Dynamics

Market Penetration and Adoption

• Prevalence of Parkinson’s Disease: Estimated at 1 million Americans and over 10 million globally, with numbers rising due to aging populations [3].
• Treatment Trends: First-line therapy remains levodopa-based formulations; combination therapies like STALEVO 200 are preferred for advanced PD stages.
• Competition: Dominated by Sinemet (carbidopa-levodopa), with key competitors including Stalevo (the original marketed version of STALEVO 200), and other dopaminergic agents.

Patent Status and Generics

• Patent Outlook: Original patent expired in 2020; generic versions of levodopa/carbidopa/entacapone are available.
• Market Exclusivity: Some regions grant data exclusivity for new formulations or delivery systems, potentially benefiting STALEVO 200’s proprietary positioning.

Pricing and Reimbursement

• Pricing: Estimated at $4–$5 per tablet in the US; higher than generic levodopa products.
• Insurance Coverage: Generally well-covered by Medicare/Medicaid and private insurers, though formulary restrictions can impact uptake.

Regulatory Trends

• Increasing emphasis on reducing motor fluctuations and OFF episodes in PD, which combination therapies like STALEVO 200 address effectively.
• Ongoing guidance encourages innovation in delivery systems and extended-release formulations.

Investment Opportunities & Risks

Opportunities

Opportunity	Rationale	Strategic Actions
Market Expansion	Growing prevalence of PD globally	Target emerging markets with tailored pricing strategies
Gap in Advanced Formulations	Superior pharmacokinetics for advanced PD	Develop newer delivery systems or sustained-release versions
Combination with Digital health	Enhancing adherence and monitoring	Partner with health tech firms for digital compliance tools

Risks

Risk	Impact	Mitigation Strategies
Patent Challenges	Reduced exclusivity period	Invest in patent portfolio extension and formulation patents
Competitive Pressures	Price erosion	Focus on clinical differentiation and patient adherence benefits
Regulatory Delays	Market entry barriers	Allocate resources towards proactive regulatory engagement

Financial Trajectory and Revenue Forecasts

Market Penetration Assumptions

Variable	Assumption	Source/Comments
Penetration Rate (2023–2028)	15% growth annually among existing PD patients	Market reports [2]
Patient Population Growth	3% CAGR, reflecting aging trends	Global health statistics [3]
Market Share of STALEVO 200	Projected to capture 60% of combination therapy segment	Competitive positioning analysis

Projected Revenue (USD)

Year	Estimated Global Revenue (millions)	Notes
2023	$120	Stable initial adoption; current market presence
2024	$140	Growth fueled by expanded indications and markets
2025	$170	Adoption in emerging markets
2026	$200	Second-generation formulations and label updates
2027	$230	Increased penetration with value-added combinations
2028	$260	Mature market plateauing

Key Revenue Drivers

• Increasing global PD prevalence.
• Product differentiation through improved pharmacokinetics.
• Strategic alliances with healthcare payers and providers.

Competitive Landscape and Positioning

Competitor	Product	Market Share (Estimated, 2023)	Key Differentiator	Regulatory Status
Sinemet	Carbidopa-Levodopa	45%	Established presence	Mature, patent expiry in 2020
Stalevo	Carbidopa-Levodopa-Entacapone	25%	Multi-action formulation	Marketed globally
New Entrants	Extended-release formulations	10%	Longer acting	Pending approval in certain markets

Regulatory Frameworks Impacting Market Dynamics

Region	Regulatory Body	Recent Policies	Impact on STALEVO 200
US	FDA	QIDP designation policies	Accelerated approval pathways
EU	EMA	Incentives for innovation in PD	Favorable for formulations with improved pharmacokinetics
Japan	PMDA	Emphasis on aging population health	Support for novel delivery systems

Comparison with Similar Therapeutics

Aspect	STALEVO 200	Sinemet	Extended-release formulations
Dosage	200 mg levodopa per tablet	100 mg levodopa per tablet	Variable
Pharmacokinetics	Immediate release (original), extended options available	Immediate release	Extended-release designed for once-daily dosing
Efficacy	Effective in reducing OFF time	Prototype standard	Similar or improved, depending on formulation
Adverse Effects	Dyskinesia, nausea	Similar	Similar, potentially fewer fluctuations

Key Market and Investment Drivers

• Rising PD prevalence and aging demographics.
• Patent expiries incentivizing creation of new formulations.
• Growing acceptance of combination therapies to improve QoL.
• Regulatory incentives for innovative delivery systems.
• Strategic partnerships to expand in emerging markets.

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Key Takeaways

• Market Growth: The global PD drug market is expanding at ~7.8% CAGR, driven by demographic shifts and product innovations.
• Competitive Position: STALEVO 200 benefits from established efficacy and multi-action therapy but faces generic competition.
• Revenue Potential: Estimated USD 120–260 million from 2023–2028, contingent on market share gains and regional expansion.
• Regulatory & Reimbursement Factors: Favorable policies in key markets can accelerate adoption; reimbursement remains a critical factor.
• Investment Risks: Patent cliffs, pricing pressures, and rapid competitive entry could impact profitability.

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FAQs

1. What distinguishes STALEVO 200 from generic levodopa formulations?
STALEVO 200 combines levodopa, carbidopa, and entacapone, offering continuous dopaminergic stimulation that reduces motor fluctuations associated with standard levodopa therapy.

2. How does patent status influence investment in STALEVO 200?
While the original patent expired in 2020, proprietary formulations, delivery systems, or combination strategies could extend exclusivity, impacting revenue streams.

3. What are the primary regulatory challenges for market expansion?
Compliance with regional approval pathways, variations in drug classification, and demonstrating clinical benefits over existing generics are critical hurdles.

4. How significant are emerging markets for STALEVO 200's growth?
Significantly, as PD prevalence rises globally; emerging markets present opportunities for increased volume through tailored pricing and partnerships.

5. What are the key future product development directions?
Focus areas include sustained-release formulations, digital adherence tools, and combination therapies integrating new mechanisms to address unmet needs in PD management.

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References

1. MarketData Forecast. "Global Parkinson’s Disease Therapeutics Market Report," 2023.
2. Global Data. "Pharmacological Trends in Parkinson’s Disease," 2022.
3. Parkinson’s Foundation. "PD Statistics," 2023.