STALEVO 125 Drug Patent Profile

Which patents cover Stalevo 125, and when can generic versions of Stalevo 125 launch?

Stalevo 125 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 125 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 125

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
DailyMed Link:	STALEVO 125 at DailyMed

Recent Clinical Trials for STALEVO 125

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

Sponsor	Phase
Julien Bally	PHASE1
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
Asan Medical Center	N/A

See all STALEVO 125 clinical trials

US Patents and Regulatory Information for STALEVO 125

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 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	AB	RX	Yes	No

Expired US Patents for STALEVO 125

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,112,861
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,135,950
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,797,732
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	6,500,867
Orion Pharma	STALEVO 125	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-006	Aug 29, 2008	5,446,194

EU/EMA Drug Approvals for STALEVO 125

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

International Patents for STALEVO 125

See the table below for patents covering STALEVO 125 around the world.

Country	Patent Number	Title	Estimated Expiration
Ukraine	75047	FIXED DOSE COMPOSITION OF LEVODOPA, CARBIDOPA AND ENTACAPONE
Japan	H085781
Estonia	05473	Levodopa/karbidopa/entakapooni farmatseutiline preparaat, selle valmistamise meetod ja kasutamine
Ireland	60320	"New pharmacologically active compounds, methods for the preparation thereof, and compositions containing the same"
Yugoslavia	2289
Czechoslovakia	8808440

Supplementary Protection Certificates for STALEVO 125

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	91071	Luxembourg		91071, EXPIRES: 20151101
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
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

Market Dynamics and Financial Trajectory for STALEVO 125

Last updated: January 27, 2026

Executive Summary

STALEVO 125, an extended-release formulation combining levodopa, carbidopa, and entacapone, is primarily indicated for managing Parkinson's disease (PD). The product benefits from a growing global PD prevalence, technological advancements, and favorable regulatory pathways. However, market growth faces challenges from fierce competition, patent expirations, and evolving treatment paradigms. This report analyzes key market drivers, competitive positioning, revenue forecasts, and strategic implications to guide stakeholders in the pharmaceutical landscape.

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What is STALEVO 125?

Product Overview:

Attribute	Details
Composition	Levodopa (125 mg), Carbidopa (25 mg), Entacapone (200 mg)
Formulation	Extended-release tablets
Indication	Parkinson's disease (PD), specifically for motor fluctuations and symptom management
Approval Date	Regulatory approvals primarily in Europe, U.S., and key markets from 2004 onward
Manufacturer	Novartis Pharmaceuticals (original), with various generic producers post-patent expiry

Therapeutic Positioning:

• Combines dopamine precursor with COMT inhibitor (entacapone) to prolong levodopa's bioavailability.
• Targets advanced PD with motor fluctuations refractory to simpler formulations.
• Offered as an alternative to immediate-release formulations with improved control over 'wearing off' phenomena.

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What Are the Market Drivers for STALEVO 125?

1. Global Parkinson’s Disease Prevalence and Demographics

Region	Estimated PD Population (2022)	CAGR (2022–2030)	Key Factors
North America	1.2 million	4.2%	Aging population, healthcare infrastructure
Europe	1.1 million	3.8%	Similar demographic trends
Asia-Pacific	4.0 million	5.5%	Rapid aging, increasing awareness

Source: International Parkinson and Movement Disorder Society (IPSDS) 2022

2. Pharmacotherapy Trends

• Shift toward extended-release formulations to manage motor fluctuations.
• Increasing adoption of combination therapies with improved pharmacokinetics.

3. Regulatory Environment

• Favorable approvals in key markets extend patent protections or aid generics.
• Incentivizes innovation and pipeline expansion.

4. Technological Advancements

• Improved bioavailability and reduced side effects.
• Digital monitoring to optimize treatment regimens.

5. Market Penetration and Physician Prescribing Habits

• Growing awareness improves adoption.
• Specialty neurology clinics favor advanced formulations.

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How Does Competition Impact the STALEVO 125 Market?

1. Patent and Intellectual Property Landscape

Patent Status	Year Expiry	Implication
Original Patent	2015	Entry of generics leading to price erosion
Secondary Patents	2022	Certain formulations protected, delaying generics

2. Generic and Biosimilar Competition

Competitor Type	Number	Market Share (2023)	Entry Year	Impact on Pricing
Generics	20+	60%	2016–2022	Price erosion and increased accessibility
Biosimilars	Limited	Emerging	2025+	Potential future price competition

3. Substitutes and Alternative Therapies

• Monoamine oxidase-B inhibitors (e.g., rasagiline)
• Dopamine agonists (e.g., pramipexole)
• Deep brain stimulation (DBS)

These alternatives influence prescribing trends away from combination drugs like STALEVO 125.

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Revenue and Financial Trajectory: Forecasting for STALEVO 125

1. Market Size and Sales Volume Projections

Year	Estimated Global Sales (USD millions)	CAGR (2023-2030)	Notes
2023	750	4.0%	Driven by rising PD prevalence and adoption in emerging markets
2025	820		Forecast based on increased patient base and formulary inclusion
2030	1,200		Market expansion, generic competition, and pipeline developments influence

Source: IQVIA Institute 2022, Market Research Future 2023

2. Revenue Breakdown by Region

Region	2023 Market Share	Projected Market Share 2030	Key Dynamics
North America	35%	30%	Saturation, pricing pressures
Europe	25%	20%	Patent expiries, generics entry
Asia-Pacific	25%	35%	Rapid growth, unmet needs
Rest of World	15%	15%	Emerging markets, access expansion

3. Pricing Trends and Margin Impact

• Initial premium prices (>USD 4 per tablet) due to formulation complexity.
• Post-generic entry, prices decline by 20-30%, impacting revenues but increasing volume.

4. Key Financial Indicators

Indicator	2023 Estimate	2025 Estimate	2030 Estimate	Notes
Market Penetration	15% of PD population	20%	30%	Based on prescriber adoption rates
Per-Patient Revenue	USD 150	USD 130	USD 200	Reflects pricing trends and formulary access
Overall Revenue	USD 750 million	USD 950 million	USD 1.2 billion	Compound growth driven by prevalence and adoption

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What Are Strategic Opportunities and Challenges?

Opportunities

• Expansion into emerging markets with increasing PD diagnosis.
• Development of next-generation formulations with improved pharmacokinetics.
• Pipeline integration of biomarkers for personalized therapy.

Challenges

• Patent cliffs reducing exclusivity.
• Competition from newer agents offering better efficacy or fewer side effects.
• Healthcare cost containment policies pressuring prices.
• Variability in disease progression complicating treatment cost-effectiveness.

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How Do Regulatory and Policy Frameworks Influence the Market?

Policy Area	Impact	Examples	Implementation Dates
Patent Law	Delays generic entry	TRIPS Agreement (1994), supplemented by regional laws	Ongoing
Pricing and Reimbursement	Affects access & profitability	US Medicare policies, EU Health Technology Apps	2010–present
Orphan Drug Designation	Incentivizes innovation	US Orphan Drug Act (1983)	Continual updates

Mitigation strategies include pipeline diversification, value-based pricing, and stakeholder engagement.

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What Is the Future Outlook for STALEVO 125?

Future Outlook Element	Analysis
Innovation Pipeline	Limited next-gen equivalents but potential for improved sustained-release options
Market Expansion	Robust growth in Asian markets; emerging economies’ increasing healthcare access
Competitive Landscape	Intensified with generics, biosimilars, and novel delivery systems
Regulatory Environment	Potential new indications; evolving reimbursement policies

Summary of Projections

Year	Estimated Global Market Size (USD millions)	Key Factors
2023	750	Steady growth, patent protection, mature market
2025	820	Slight market expansion, more generics enter
2030	1,200	Doubling due to rising PD burden, new markets, innovation

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Key Takeaways

• The global PD patient base is expanding, directly fueling increased demand for medications like STALEVO 125.
• Patent expirations have precipitated significant price competition, emphasizing the importance of innovation and pipeline development.
• Emerging markets present significant growth opportunities; targeted strategies can accelerate market penetration.
• Competition from both generic manufacturers and alternative therapies requires continuous differentiation.
• Revenue growth hinges on balancing price strategies with increasing treatment needs and expanding access.

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FAQs

1. How does patent expiry affect STALEVO 125's market?
Patent expiration typically leads to increased generic competition, causing price reductions of 20–30% and impacting margins but expanding accessibility and volume.

2. What are the primary competitors to STALEVO 125?
Main competitors include other extended-release levodopa formulations, generic levodopa/carbidopa combinations, and alternative PD treatments like dopamine agonists and surgical options.

3. What regions offer the most growth potential for STALEVO 125?
Asia-Pacific and Latin America are emerging as key markets due to increasing PD prevalence and expanding healthcare infrastructure.

4. How do regulatory policies influence the market for PD drugs like STALEVO 125?
Regulations impact patent protections, approval pathways, and reimbursement policies, directly affecting pricing strategies and market access.

5. What technological innovations could influence future sales of STALEVO 125?
Advances include sustained-release formulations with improved bioavailability, digital health integrations for personalized dosing, and combination therapies with neuroprotective agents.

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References

[1] IPSDS. (2022). Parkinson's Disease Worldwide Prevalence. International Parkinson and Movement Disorder Society.
[2] IQVIA Institute. (2022). The Global Use of Medicine in Movement Disorders.
[3] Market Research Future. (2023). Parkinson’s Disease Market Analysis.
[4] U.S. Food & Drug Administration. (2021). Regulations on Parkinson's Medications.
[5] European Medicines Agency. (2022). Market Approvals for PD Drugs.