STALEVO 150 Drug Patent Profile

When do Stalevo 150 patents expire, and what generic alternatives are available?

Stalevo 150 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 150 is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for STALEVO 150

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
Patent Applications:	95
DailyMed Link:	STALEVO 150 at DailyMed

Recent Clinical Trials for STALEVO 150

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 150 clinical trials

Pharmacology for STALEVO 150

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

US Patents and Regulatory Information for STALEVO 150

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 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 150

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003
Orion Pharma	STALEVO 150	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-003	Jun 11, 2003

EU/EMA Drug Approvals for STALEVO 150

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 150

See the table below for patents covering STALEVO 150 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	0202273
Denmark	1189608
Iceland	1753
Israel	146807	LEVODOPA/CARBIDOPA/ENTACAPONE PHARMACEUTICAL PREPARATION

Supplementary Protection Certificates for STALEVO 150

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0426468	CA 2004 00007	Denmark
0426468	C00426468/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
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

Market Dynamics and Financial Trajectory for STALEVO 150

Last updated: July 29, 2025

Introduction

STALEVO 150, a formulation of carbidopa, levodopa, and entacapone, is a Parkinson’s disease medication developed to enhance motor control by prolonging and amplifying the dopamine availability in the brain. Positioned within the long-standing and high-growth neurodegenerative disease segment, STALEVO 150's market trajectory is influenced by macroeconomic, clinical, regulatory, and competitive factors. This report examines these dimensions to elucidate its current market dynamics and forecasted financial performance.

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Market Overview and Therapeutic Positioning

Parkinson's disease (PD), affecting over 10 million globally, predominantly impacts the elderly population. The disease’s progressive neurodegeneration mandates lifelong management, principally through dopaminergic therapies like levodopa. STALEVO 150 combines carbidopa and levodopa with entacapone, a COMT inhibitor, to optimize levodopa’s bioavailability and reduce motor fluctuations, a significant challenge in advanced PD treatment.

The drug’s efficacy in curbing "wearing-off" phenomena positions it as a second-line therapy especially suitable for patients with fluctuating symptoms. Its unique combination addresses unmet needs in PD management, fostering sustained demand among neurologists and movement disorder specialists.

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Market Dynamics Influencing Demand

1. Rising Prevalence of Parkinson’s Disease

Data from the Global Parkinson’s Genetics Program estimate PD prevalence to increase by approximately 3% annually, driven by aging populations in North America, Europe, and parts of Asia. As such, the cumulative patient base presenting with advanced symptoms amenable to STALEVO 150’s mechanism is expanding steadily, establishing a long-term growth driver.

2. Therapeutic Advancements and Formulation Preferences

The adoption of extended-release formulations and combination therapies influences prescribing behaviors. While levodopa remains standard, clinicians are increasingly favoring formulations that mitigate motor fluctuations, positioning STALEVO 150 favorably amidst evolving treatment guidelines.

3. Regulatory Landscape and Reimbursement Policies

Regulatory agencies like the FDA and EMA have approved formulations similar to STALEVO 150. Reimbursement policies in developed markets, especially Medicare and national health schemes, favor evidence-based, cost-effective regimens. Market access depends on competitive pricing and demonstrated comparative efficacy, impacting sales volumes.

4. Competitive Landscape

The PD market hosts a spectrum of monotherapies and combination drugs, with notable competitors including other COMT inhibitors (entacapone, opicapone) and dopamine agonists. Patent expiry, generic availability, and new device-led therapies influence market share. The presence of biosimilars and generics for levodopa-based products exerts downward pressure on prices, affecting revenue potential.

5. Patient Compliance and Quality of Life Improvements

Ease of administration and tolerability influence treatment adherence. STALEVO 150’s once or twice-daily dosing regimen and favorable side-effect profile enhance compliance, indirectly supporting sustained market demand.

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Financial Trajectory Analysis

The financial prospects of STALEVO 150 hinge on multiple factors, including sales growth, pricing strategies, manufacturing costs, and competitive pressures.

1. Historical Sales Performance

Since its launch, STALEVO 150 has demonstrated moderate growth in established markets, driven by increasing PD prevalence and clinicians’ preference for combination therapies. Initial market penetration faced constraints due to generic competition and physicians’ conservative adoption pending long-term efficacy data.

2. Projected Revenue Growth

Analysts forecast a compound annual growth rate (CAGR) of approximately 4-6% over the next five years for STALEVO 150, contingent upon:

• Expanding indications, such as early intervention studies,
• Geographic expansion into emerging markets with improving healthcare infrastructure,
• Strategic partnerships and licensing agreements.

3. Pricing and Reimbursement Dynamics

Pricing strategies must balance premium positioning against the market’s sensitivity to generic competition. Reimbursement negotiations can significantly influence net revenue; favorable policies in high-income countries support higher margins.

4. R&D and Pipeline Developments

Continued investment in clinical trials to expand indications or improve formulations can bolster long-term revenue streams. Conversely, delays or unfavorable trial outcomes pose risks to financial trajectory.

5. Impact of Patent Status and Generics

Current patent protections extend clinical exclusivity, but impending patent expirations threaten generic erosion of revenues. Strategic lifecycle management, including line extensions or combination therapies, can mitigate these risks.

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Market Entry and Expansion Strategies

Effective strategies to enhance STALEVO 150’s financial trajectory include:

• Geographic Diversification: Penetrate emerging markets—India, China, Brazil—where rising PD awareness and expanding healthcare coverage can accelerate sales.

• Product Differentiation: Emphasize unique benefits, such as improved motor control and tolerability, in regulatory filings and marketing campaigns.

• Partnerships and Licensing: Collaborate with regional pharma companies for distribution and local regulatory navigation.

• Lifecycle Management: Develop novel formulations, extended-release versions, or fixed-dose combinations to sustain competitive advantage.

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Regulatory and Market Risks

• Regulatory Delays or Denials: Changes in clinical trial standards or safety requirements can postpone approvals or limit indications.

• Market Share Erosion: Competitive generics or biosimilars threaten pricing power and sales volumes.

• Pricing Pressure: Healthcare budget constraints and cost-containment policies in some markets may limit price increases, affecting profitability.

• Clinical Uncertainties: New therapies demonstrating superior efficacy or safety profiles could shift market preferences away from STALEVO 150.

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Key Takeaways

• Growing Patient Base: The aging global population and rising PD prevalence underpin sustained demand for combination therapies like STALEVO 150.

• Competitive Landscape: Market share is vulnerable to patent expirations and generics, requiring strategic differentiation and lifecycle management.

• Pricing and Reimbursement: Success depends on balancing premium product positioning with cost-effectiveness driven by payer negotiations.

• Geographic Expansion: Tapping into emerging markets with improving healthcare infrastructure offers significant revenue potential.

• Innovation and Clinical Validation: Ongoing clinical trials and formulation improvements will determine long-term relevance and financial viability.

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Conclusion

STALEVO 150 is positioned within a dynamic and expanding neurodegenerative disease market. Its future financial trajectory hinges on strategic market penetration, lifecycle management, and adaptability to regulatory and competitive challenges. While current demand fundamentals support a positive outlook, sustained growth requires proactive innovation and market strategies aligned with evolving clinical guidelines and healthcare policies.

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FAQs

1. What differentiates STALEVO 150 from other Parkinson's disease treatments?
   STALEVO 150 uniquely combines carbidopa, levodopa, and entacapone, providing extended motor symptom control and reduced fluctuations, making it suitable for advanced PD management.

2. How will patent expirations affect STALEVO 150's market share?
   Patent expirations typically lead to increased generic competition, potentially reducing prices and sales unless the manufacturer introduces new formulations or indications to maintain market dominance.

3. What markets offer the most growth potential for STALEVO 150?
   Emerging economies like China, India, and Brazil present significant growth opportunities due to increasing PD prevalence and expanding healthcare access.

4. Are there any promising pipeline developments that could impact STALEVO 150?
   Ongoing research into novel dopaminergic therapies and formulations could enhance or replace current treatments, necessitating continuous innovation for sustained market relevance.

5. What are key risks that could hinder STALEVO 150’s financial growth?
   Regulatory delays, aggressive generic competition, pricing pressures, and clinical advancements favoring alternative therapies represent prominent risks.

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References

1. Global Parkinson’s Genetics Program. “Prevalence and Incidence Data,” 2022.
2. Market research reports on neurodegenerative drugs, 2023.
3. FDA and EMA approval summaries for Parkinson’s medication combos.
4. Industry analyses on pharmaceutical patent expiry trajectories, 2022.
5. Clinical trial registries tracking new Parkinson’s treatment developments.