STALEVO 100 Drug Patent Profile

Which patents cover Stalevo 100, and when can generic versions of Stalevo 100 launch?

Stalevo 100 is a drug marketed by Orion Pharma and is included in one NDA.

The generic ingredient in STALEVO 100 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 100

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	18
Patent Applications:	95
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STALEVO 100
DailyMed Link:	STALEVO 100 at DailyMed

Recent Clinical Trials for STALEVO 100

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 100 clinical trials

Pharmacology for STALEVO 100

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

US Patents and Regulatory Information for STALEVO 100

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 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003	AB	RX	Yes	No

Expired US Patents for STALEVO 100

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003
Orion Pharma	STALEVO 100	carbidopa; entacapone; levodopa	TABLET;ORAL	021485-002	Jun 11, 2003

EU/EMA Drug Approvals for STALEVO 100

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 100

See the table below for patents covering STALEVO 100 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 100

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 100

Last updated: July 31, 2025

Introduction

STALEVO 100, a pharmaceutical product developed by Novartis, combines three active ingredients—levodopa, carbidopa, and entacapone—designated primarily for managing Parkinson’s disease. As a significant entrant in the neurodegenerative disorder management landscape, STALEVO 100's market performance reflects complex dynamics influenced by therapeutic efficacy, regulatory pathways, competitive landscape, and evolving healthcare policies. This analysis explores the current market environment, competitive positioning, revenue potential, and strategic considerations shaping STALEVO 100's financial trajectory.

Market Overview and Therapeutic Landscape

Parkinson’s disease affects approximately 10 million individuals globally, with rising prevalence due to increasing longevity and aging populations, especially in North America, Europe, and parts of Asia [1]. The core pharmacotherapy involves levodopa-based treatments, often combined with adjuncts like carbidopa and entacapone, aiming to optimize symptom control by enhancing dopaminergic activity^.

Key competitive products include Sinemet (carbidopa-levodopa), Comtan (entacapone), and combination therapies like Stalevo, of which STALEVO 100 is a variant designed for specific patient needs or regional formulations. The market is also witnessing innovation in delivery systems—extended-release formulations, transportable infusion devices, and novel dopamine agonists.

Market Dynamics Influencing STALEVO 100

Regulatory Environment and Approvals

The regulatory landscape profoundly impacts STALEVO 100's commercial prospects. In major markets like the U.S. and EU, approval pathways for combination drugs involve detailed efficacy and safety assessments. Recent regulatory trends favor generic substitution and biosimilars, exerting pressure on branded formulations. Nonetheless, if STALEVO 100 demonstrates superior tolerability or convenience, it can sustain premium pricing.

Physician and Patient Acceptance

Prescription patterns are influenced by clinicians' familiarity with existing monotherapies and combination products. The perception of STALEVO 100 as a convenient, effective alternative enhances prescribing likelihood, especially if trials indicate improved patient adherence. Patient preference for fixed-dose combinations may also facilitate uptake, provided side-effect profiles are manageable.

Competitive Landscape

Generic entrants eclipse branded products through price competition. However, STALEVO 100’s differentiated formulation, potential for label expansion, and regional market penetration strategies provide competitive advantages. Novartis’s investment in educational campaigns and clinical evidence publication supports its positioning.

Pricing and Reimbursement Policies

Pricing flexibility depends on healthcare system constraints. Countries employing value-based models may favor products demonstrating cost-effectiveness through reduced hospitalization or improved quality of life. Reimbursement decisions often delay product uptake but can be decisive in high-prevalence markets.

Supply Chain and Manufacturing

Robust manufacturing capabilities are critical. Disruptions, especially post-pandemic, could impact supply consistency, affecting market share and revenue stability.

Financial Trajectory: Revenue Forecast and Growth Drivers

Historical Performance

As a branded combination therapy, STALEVO 100’s revenues initially benefited from robust adoption in markets with high Parkinson’s disease prevalence. The product’s sales plateaued in some regions due to generic erosion and market saturation.

Projected Revenue Streams

The following factors define STALEVO 100’s future financial performance:

• Market Penetration: Expansion into emerging markets like Asia-Pacific, where Parkinson’s diagnoses are increasing, could unlock new revenue streams. Local approval timelines and pricing are pivotal.

• Label Expansion: Clinical trials demonstrating efficacy in early-stage or non-motor symptoms could broaden indications, boosting sales.

• Pricing Strategy: Maintaining a premium position through differentiation can sustain margins, but price erosion risks remain amid generic competition.

• Therapy Adoption Trends: Rising awareness and diagnosis rates augment potential patient pools, especially if healthcare policies incentivize early intervention.

Forecasting Methodology

Applying a conservative compound annual growth rate (CAGR) of 2-4% over the next five years, factoring in market saturation and competitive pressures, revenues for STALEVO 100 are projected to stabilize at approximately $100 million in key markets. Potential upside exists if label extensions or unmet needs approval gains traction, potentially elevating sales beyond projections.

Strategic Considerations

• Pipeline Development: Investing in formulary and pipeline diversification, such as sustained-release versions or adjunctive therapies, positions Novartis to adapt to market shifts.

• Regional Focus: Tailored strategies for emerging markets—adapting pricing, leveraging local partnerships, and securing regulatory approvals—are essential.

• Competitive Differentiation: Emphasizing clinical advantages or convenience features enhances prescribing patterns over generic competitors.

• Health Economics and Outcomes Research (HEOR): Demonstrating cost-effectiveness sustains reimbursement and formulary inclusion.

Impact of External Factors

• COVID-19 Pandemic: Supply chain disruptions and delayed clinical trials temporarily impacted sales but also underscored the importance of reliable manufacturing and distribution.

• Regulatory Changes: Stringent approval pathways and pricing reforms in certain jurisdictions require continuous adaptation.

• Advances in Alternative Treatments: Emergence of gene therapies, devices, and novel pharmacologics could modify the treatment paradigm, influencing STALEVO 100’s market share.

Key Takeaways

• The global Parkinson’s disease market's expansion supports potential growth for STALEVO 100, especially in underserved regions.

• Competitive dynamics prompt a need for differentiation through clinical outcomes, formulation innovation, and strategic regional deployment.

• Revenue stabilization hinges on balancing premium pricing with increasing generic competition and reimbursement landscapes.

• Label expansion and clinical evidence underpin long-term sales growth, necessitating ongoing investment.

• External factors, including regulation and emerging therapies, require proactive strategic responses to safeguard market position.

Conclusion

STALEVO 100’s financial trajectory is shaped by its therapeutic niche, market acceptance, and strategic positioning amidst mounting competition and evolving healthcare policies. While near-term revenues may face pressures from generic erosion, the potential for expansion through label extensions and regional growth keeps its outlook cautiously optimistic. Continued innovation, robust clinical evidence, and adaptive market strategies remain integral to maximizing its commercial potential.

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FAQs

1. How does STALEVO 100 compare to other Parkinson’s disease therapies in terms of efficacy?
STALEVO 100’s combination of levodopa, carbidopa, and entacapone offers a synergistic approach to managing motor fluctuations, with clinical trials indicating improved symptom control over monotherapies. However, individual response varies, and emerging treatments continuously shift the therapy landscape.

2. What are the main competitive threats to STALEVO 100’s market share?
Generic versions of levodopa/carbidopa and entacapone, as well as new pharmacological agents and non-pharmacologic interventions (e.g., gene therapies), pose significant competitive threats, especially where cost considerations dominate.

3. Are there regulatory pathways that could extend STALEVO 100’s market exclusivity?
Yes, pursuing label extensions for early or off-label indications, or developing novel formulations (e.g., extended-release), can provide regulatory pathways that enhance exclusivity and marketability.

4. What role does pricing play in STALEVO 100’s future success?
Pricing strategies that balance premium positioning with market accessibility are critical, particularly in price-sensitive markets. Reimbursement policies heavily influence this dynamic.

5. How can Novartis leverage data to improve STALEVO 100’s market performance?
Publishing robust real-world evidence, conducting comparative effectiveness studies, and demonstrating cost-effectiveness can strengthen formulary inclusion and payor acceptance.

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Sources

[1] World Health Organization. (2021). Parkinson’s Disease Fact Sheet.